14 Car Manufacturing jobs in the United States

CAR T Manufacturing Operator

08869 Raritan, New Jersey J&J Family of Companies

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Job Description

At Johnson & Johnson,?we believe health is everything. Our strength in healthcare innovation empowers us to build a?world where complex diseases are prevented, treated, and cured,?where treatments are smarter and less invasive, and?solutions are personal?Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity?Learn more at Function:**
Supply Chain Manufacturing
**Job Sub** **Function:**
Manufacturing Assembly
**Job Category:**
Business Enablement/Support
**All Job Posting Locations:**
Raritan, New Jersey, United States of America
**Job Description:**
**About Innovative Medicine**
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.
Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.
Learn more at are searching for the best talent for CAR-T Manufacturing Operator to be in Raritan, NJ.**
**Purpose:** This position is responsible for performing manufacturing procedures and the execution of scheduled tasks within a CGMP environment. This position is responsible for quality and maintaining the highest standards in compliance with company policies, procedures, and all applicable regulations. Responsible for fostering site pride and J&J citizenship.
**You will be responsible for:**
-Be part of the manufacturing operations team responsible for the production of autologous CAR-T products for clinical and commercial operation in a controlled current Good Manufacturing Practice (cGMP) cleanroom environment.
-Independently execute manufacturing or manufacturing-support processes according to standard operating procedures and current curriculum.
-Execute manufacturing activities common to cell culturing, purification, aseptic processing, and cryopreservation using appropriate techniques.
-Perform process unit operations according to standard operating procedures and batch records, and record production data and information in a clear, concise, format according to Good Documentation Practices (GDP).
-Work in a team-based, cross-functional environment to complete production tasks required by shift schedule.
-Aid in the development of manufacturing processes including appropriate documentation.
-Drive continuous improvement of manufacturing operations leveraging own observation as well as input of team members.
-Handle human-derived materials in containment areas.
-Support schedule adjustments to meet production.
-Accurately complete documentation in SOP's, logbooks, and other GMP documents.
-Demonstrate training progression through the assigned curriculum.
-Accountable for maintaining a working knowledge of basic cGMP requirements to ensure adherence to compliance policies and regulations.
-Wear the appropriate PPE when working in manufacturing and other hazardous working environments.
-Proactively maintain a clean and safe work environment. Take necessary action to eliminate safety hazards and communicate to others any observed unsafe behaviors.
-Ensure materials are available for production.
-Perform tasks on time in a manner consistent with quality systems and cGMP requirements.
**ADDITIONAL RESPONSIBILITIES/DUTIES:**
-Support the ongoing production schedule by:
O Report to work on time and according to the shift schedule.
O Perform other duties as assigned.
O Attend departmental and other scheduled meetings.
O Practice good interpersonal and communication skills.
O Demonstrate a positive team-oriented approach in the daily execution of procedures.
O Promote and work within a team environment.
O Learn new skills, procedures, and processes as assigned by management and continue to develop professionally.
-Support investigation efforts as required.
-Responsible for audit preparation and participation.
*This is not an exhaustive or comprehensive listing of job functions. May perform other duties as assigned.
**AUTONOMY and COMPLEXITY:**
+ Needs direction to perform manufacturing daily tasks within functional area.
+ Support and contributes to projects
+ Assist in troubleshooting routine manufacturing processes
+ Support and execute non-routine manufacturing activities.
**NATURE OF TASKS:**
+ Basic technical knowledge within functional units
+ Demonstrate a basic understanding of the process to properly perform the assigned manufacturing tasks.
**COMPUTER ABILITY:**
+ Basic understanding and working knowledge of systems required per curriculum. Utilizes tools within MS Office and other systems to improve business effectiveness.
+ Accurate Data Entry skills in relevant manufacturing applications (SAP, electronic batch records (EBR), etc.)
**Qualifications / Requirements:**
**EDUCATION AND EXPERIENCE:**
HS Diploma required with 4-6 Years of Biotech/Pharmaceutical experience or equivalent industry experience.
**OR**
Associate degree required with 2-4 Years of Biotech/Pharmaceutical experience or equivalent industry experience.
**OR**
Bachelor's degree required in Life Sciences or Engineering, with 0-2 years of Biotech/Pharmaceutical experience or equivalent industry experience.
**LANGUAGE SKILLS:**
+ Read and interpret documents such as safety rules, operating instructions, and logbooks
+ Review and provide feedback for SOP and Batch Record Revisions
**REASONING ABILITY:**
+ Interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
+ Follow instructions
+ Solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
**MATHEMATICAL SKILLS:**
+ Add, subtract, multiply and divide into all units of measure, using whole numbers, common fractions, and decimals.
**OTHER SKILLS, ABILITIES, OR QUALIFICATIONS:**
+ Knowledge and ability to operate manufacturing, manufacturing-support, and lab equipment.
+ Knowledge of Process Excellence Tools
+ Possesses solid knowledge of routine and non-routine testing and sampling methods, techniques, and related equipment.
**PHYSICAL DEMANDS:**
**While performing the duties of this job, the employee:**
+ Needs to be mobile and able to independently transport themselves between various sites/locations, as dictated by the essential functions and responsibilities of the position.
+ Is frequently required to communicate with coworkers.
+ While performing the duties of this job, the employee is regularly required to stand; walk; climb, bend, stoop; and reach with hands and arms.
+ Ability to lift 25 lbs.
+ Needs to perform gowning procedures to work in the manufacturing core.
***The Raritan CAR-T Manufacturing organization is committed to working with any applicant or employee to make reasonable accommodations in the job structure in consideration of any known physical challenges or disabilities.**
**_Additional Information:_**
The anticipated base pay range for this position is $40,000 to $4,400.
The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/performance year. Bonuses are awarded at the Company's discretion on an individual basis. ·
+ Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
+ Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).
+ This position is eligible to participate in the Company's long-term incentive program.
+ Employees are eligible for the following time off benefits:
+ Vacation - up to 120 hours per calendar year
+ Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year
+ Holiday pay, including Floating Holidays - up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year
+ Additional information can be found through the link below. compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center ( ) or contact AskGS to be directed to your accommodation resource.
**The anticipated base pay range for this position is :**
The anticipated base pay range for this position is $ 0,000 to 64,400.
Additional Description for Pay Transparency:
The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/performance year. Bonuses are awarded at the Company's discretion on an individual basis. · - Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. - Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). - This position is eligible to participate in the Company's long-term incentive program. - Employees are eligible for the following time off benefits: ? Vacation - up to 120 hours per calendar year ? Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year ? Holiday pay, including Floating Holidays - up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year - Additional information can be found through the link below. The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.
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CAR T Manufacturing Operator

08869 Raritan, New Jersey Johnson and Johnson

Posted 11 days ago

Job Viewed

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Job Description

Permanent

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at

Job Function:

Supply Chain Manufacturing

Job Sub Function:

Manufacturing Assembly

Job Category:

Business Enablement/Support

All Job Posting Locations:

Raritan, New Jersey, United States of America

Job Description:

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at are searching for the best talent for CAR-T Manufacturing Operator to be in Raritan, NJ.

 

Purpose:  This position is responsible for performing manufacturing procedures and the execution of scheduled tasks within a CGMP environment. This position is responsible for quality and maintaining the highest standards in compliance with company policies, procedures, and all applicable regulations. Responsible for fostering site pride and J&J citizenship.

 

You will be responsible for:

•Be part of the manufacturing operations team responsible for the production of autologous CAR-T products for clinical and commercial operation in a controlled current Good Manufacturing Practice (cGMP) cleanroom environment.

•Independently execute manufacturing or manufacturing-support processes according to standard operating procedures and current curriculum.

•Execute manufacturing activities common to cell culturing, purification, aseptic processing, and cryopreservation using appropriate techniques.

•Perform process unit operations according to standard operating procedures and batch records, and record production data and information in a clear, concise, format according to Good Documentation Practices (GDP).

•Work in a team-based, cross-functional environment to complete production tasks required by shift schedule.

•Aid in the development of manufacturing processes including appropriate documentation.

•Drive continuous improvement of manufacturing operations leveraging own observation as well as input of team members.

•Handle human-derived materials in containment areas.

•Support schedule adjustments to meet production.

•Accurately complete documentation in SOP’s, logbooks, and other GMP documents.

•Demonstrate training progression through the assigned curriculum.

•Accountable for maintaining a working knowledge of basic cGMP requirements to ensure adherence to compliance policies and regulations.

•Wear the appropriate PPE when working in manufacturing and other hazardous working environments.

•Proactively maintain a clean and safe work environment. Take necessary action to eliminate safety hazards and communicate to others any observed unsafe behaviors.

•Ensure materials are available for production.

•Perform tasks on time in a manner consistent with quality systems and cGMP requirements.

 

ADDITIONAL RESPONSIBILITIES/DUTIES:

 

•Support the ongoing production schedule by:

O Report to work on time and according to the shift schedule.

O Perform other duties as assigned.

O Attend departmental and other scheduled meetings.

O Practice good interpersonal and communication skills.

O Demonstrate a positive team-oriented approach in the daily execution of procedures.

O Promote and work within a team environment.

O Learn new skills, procedures, and processes as assigned by management and continue to develop professionally.

•Support investigation efforts as required.

•Responsible for audit preparation and participation.

 

 

*This is not an exhaustive or comprehensive listing of job functions.  May perform other duties as assigned.

 

 

AUTONOMY and COMPLEXITY:

  • Needs direction to perform manufacturing daily tasks within functional area.
  • Support and contributes to projects
  • Assist in troubleshooting routine manufacturing processes
  • Support and execute non-routine manufacturing activities.

 

NATURE OF TASKS:

  • Basic technical knowledge within functional units
  • Demonstrate a basic understanding of the process to properly perform the assigned manufacturing tasks.

 

COMPUTER ABILITY:

  • Basic understanding and working knowledge of systems required per curriculum. Utilizes tools within MS Office and other systems to improve business effectiveness.
  • Accurate Data Entry skills in relevant manufacturing applications (SAP, electronic batch records (EBR), etc.)

 

Qualifications / Requirements:

EDUCATION AND EXPERIENCE:

HS Diploma required with 4-6 Years of Biotech/Pharmaceutical experience or equivalent industry experience.

OR

Associate degree required with 2-4 Years of Biotech/Pharmaceutical experience or equivalent industry experience.

OR

Bachelor’s degree required in Life Sciences or Engineering, with 0-2 years of Biotech/Pharmaceutical experience or equivalent industry experience.

 

LANGUAGE SKILLS:

  • Read and interpret documents such as safety rules, operating instructions, and logbooks
  • Review and provide feedback for SOP and Batch Record Revisions

 

REASONING ABILITY:

  • Interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
  • Follow instructions
  • Solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.

 

MATHEMATICAL SKILLS:

  • Add, subtract, multiply and divide into all units of measure, using whole numbers, common fractions, and decimals.

 

OTHER SKILLS, ABILITIES, OR QUALIFICATIONS:

  • Knowledge and ability to operate manufacturing, manufacturing-support, and lab equipment.
  • Knowledge of Process Excellence Tools
  • Possesses solid knowledge of routine and non-routine testing and sampling methods, techniques, and related equipment.

 

PHYSICAL DEMANDS:

While performing the duties of this job, the employee:

  • Needs to be mobile and able to independently transport themselves between various sites/locations, as dictated by the essential functions and responsibilities of the position.
  • Is frequently required to communicate with coworkers.
  • While performing the duties of this job, the employee is regularly required to stand; walk; climb, bend, stoop; and reach with hands and arms.
  • Ability to lift 25 lbs.
  • Needs to perform gowning procedures to work in the manufacturing core.

 

*The Rari tan CAR-T Manufacturing organization is committed to working with any applicant or employee to make reasonable accommodations in the job structure in consideration of any known physical challenges or disabilities.

Additional Information:

The anticipated base pay range for this position is $40,000 to $4,400.

 

The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year. Bonuses are awarded at the Company’s discretion on an individual basis. ·

  • Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
  • Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
  • This position is eligible to participate in the Company’s long-term incentive program.
  • Employees are eligible for the following time off benefits:
    • Vacation – up to 120 hours per calendar year
    • Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year
    • Holiday pay, including Floating Holidays – up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year
  • Additional information can be found through the link below. 

 

The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.

 

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center ( ) or contact AskGS to be directed to your accommodation resource.

The anticipated base pay range for this position is :

The anticipated base pay range for this position is $40,000 to $64,400.

u>Additional Description for Pay Transparency:

The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year. Bonuses are awarded at the Company’s discretion on an individual basis. · • Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. • Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)). • This position is eligible to participate in the Company’s long-term incentive program. • Employees are eligible for the following time off benefits: ○ Vacation – up to 120 hours per calendar year ○ Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year ○ Holiday pay, including Floating Holidays – up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year • Additional information can be found through the link below. The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.

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Manufacturing Associate, Liso-cel CAR-T, Manufacturing Operations

07901 Summit, New Jersey Bristol Myers Squibb

Posted today

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Job Description

**Working with Us**
Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us .
At Bristol Myers Squibb we are reimagining the future of **Cell Therapy** . With our bold ambition, backed by a best-in-the-industry team and long-term commitment, we are leading the way to unlock the full promise of Cell Therapy as we strive to put more patients on the path to a cure. If you are ready to challenge yourself, accelerate your career, and give new hope to patients, there's no better place than here at BMS with our Cell Therapy team.
The **Manufacturing Associate, Liso-cel CAR-T, Manufacturing Operations** manufactures human blood derived components per Standard Operating Procedures (SOPs) in a controlled, cGMP cleanroom environment under the supervision of Manufacturing Management. Manufacturing Associates adhere to regulatory requirements while performing job functions. Job duties are performed within a team according to an assigned, production shift schedule. Communication of production deviations and assistance with quality investigations are required, as applicable. Start and end times are subject to change based on business demands.
**Shifts Available:**
Wednesday to Saturday - 12-hour shift (every other Wed off)
+ 5 p.m. to 5:30 a.m.
**Responsibilities:**
+ Perform set-up and operation of equipment to support production of blood component lots through cell culture, harvest, and cryopreservation.
+ Support deviation investigations and write ups as needed. Support on time closure of any assigned CAPAs within the designated shift.
+ Aseptic technique is required for tube most activities: welding, connections, and transfers, at minimum. Aseptic qualification is required.
+ Weighs and measures in-process materials to ensure proper quantities are added/removed.
+ Adheres to the production schedule ensuring on-time, internal production logistics.
+ Records production data and information in a clear, concise, format according to proper GDPs.
+ Perform all tasks in a manner consistent with site safety policies, quality systems, and GMP requirements.
+ Works in a team based, cross-functional environment to complete production tasks required by shift schedule.
+ Motivated, team consciousness individuals are needed to fulfill job requirements.
+ Become a SME and qualified trainer within a designated function of manufacturing.
+ Supervision will be managed by the shift Supervisor or designated Team Lead.
+ Maintain on time completion of training assignments to maintain the necessary technical skills and process knowledge.
+ Performs other tasks as assigned: continuous improvement projects, inspection readiness, right first-time initiatives, etc.
**Knowledge & Skills:**
+ Basic understanding of cell culture, cryopreservation, purification, and aseptic processing or lab technique.
+ Knowledge of cGMP/FDA regulated industry.
+ Basic mathematical skills - General understanding of cGMPs.
+ Technical writing capability.
+ Proficient in MS Office applications.
+ Background to include an understanding of biology, chemistry, medical or clinical practices.
+ Pre-requisites: Prior experience in Manufacturing and/or scientific/engineering education.
**Basic Requirements:**
+ High School diploma/GED and 2 years of Manufacturing or Operations experience.
**Preferred Requirements:**
+ Bachelor's degree.
+ Associate / Medical Technical degree and 3 years of Manufacturing Operations experience.
**Working Conditions:**
+ Intermittent walking and sitting to perform job functions; however, ability to sit or stand for extended periods of time may be necessary.
+ Must be comfortable working with contained human blood components.
+ Physical dexterity sufficient to use computers and documentation.
+ Sufficient vision and hearing capability to work in job environment.
+ Ability to lift 25 pounds.
+ Must have the ability to work around laboratories and controlled, enclosed, restricted areas.
+ Cleanroom garments and personal protective equipment will be required in designated areas which cover head, parts of the face, core body, and legs/feet.
+ Makeup, gum, nail polish, or other potential microbial sources are prohibited in restricted areas.
+ Flexibility to don clean room garments and personal protective equipment (PPE).
+ Clean room environment is an enclosed, restricted space, with assigned pressure and temperature conditions.
+ Reagents, chemicals, and exposure to sanitization agents are expected.
+ Routine exposure to human blood components. Exposure to strong magnets is likely.
+ Designated areas may prohibit food, any outside materials such as cell phones, tablets, at a minimum.
+ This job description is intended to describe the general nature and level of work being performed by the person assigned to this position.
+ The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.
+ This job description does not state or imply that the above are the only duties and responsibilities assigned to this position.
+ There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job.
+ Employees holding this position will be required to perform any other job-related duties as requested by management.
The starting compensation for this job is a range from $57,880 - 70,100, plus incentive cash and stock opportunities (based on eligibility).
The starting pay rate takes into account characteristics of the job, such as required skills and where the job is performed.
Final, individual compensation will be decided based on demonstrated experience.
Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit .
Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: Medical, pharmacy, dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support. Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year's holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Parental, caregiver, bereavement, and military leave. Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources. Other perks like tuition reimbursement and a recognition program.
BMSCART
GPS_2025
VETERAN
#LI-Onsite
If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
**Uniquely Interesting Work, Life-changing Careers**
With a single vision as inspiring as Transforming patients' lives through science , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
**On-site Protocol**
BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to . Visit careers.bms.com/ ( eeo-accessibility to access our complete Equal Employment Opportunity statement.
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
**Company:** Bristol-Myers Squibb
**Req Number:** R1593238
**Updated:** 2025-07-24 04:17:35.235 UTC
**Location:** Summit West-NJ
Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.
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Associate Director, CAR-T Manufacturing Operations

07902 Summit, New Jersey Bristol-Myers Squibb

Posted today

Job Viewed

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Job Description

Working with Us

Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us .

At Bristol Myers Squibb, we are reimagining the future of cell therapy. With our bold ambition, backed by a best-in-the-industry team and long-term commitment, we are leading the way to unlock the full promise of cell therapy as we strive to put more patients on the path to a cure. If you are ready to challenge yourself, accelerate your career, and give new hope to patients, there's no better place than here at BMS with our Cell Therapy team.

The purpose of the Associate Director, Value Stream CAR T Manufacturing role is to manage and provide oversight of a team of Manufacturing Sr. Managers, Managers, and their Work Centered Teams (WCT) operating in shifts over a 24/7 schedule whose primary responsibility is the execution of Cell Therapy manufacturing processes, maintaining a culture of safety, compliance, innovation, and Continuous Improvement within the Manufacturing Operations function.

Shift Available:

  • Tuesday - Saturday, Onsite Afternoon Shift, 3 p.m. - 11:30 p.m.

Responsibilities:

Values

  • Leads by example and drives their team to adhere to the BMS values of Inclusion, Accountability, Innovation, Urgency and Passion.

  • Leads with empathy while maintaining team accountability.

  • Able to achieve results while creating an engaging, accountable, and learning culture.

GMP

  • Is accountable to ensure their Manufacturing Sr. Managers, Managers and their WCT members execute the manufacturing of Cell Therapy products according to Current Good Manufacturing Practices (cGMP's) following the current, approved Standard Operating Procedures (SOPs) and Work Instructions (WIs).

  • Responsible to own, review, author, or approve SOP, WI, master batch records.

  • Responsible for setting strategic direction for the WCT while maintaining or exceeding compliance, budgetary, safety, and technical requirements.

  • Has direct experience and success with Health Authorities and is capable to defend CAR-T manufacturing processes.

  • Provides compliant solutions to technical issues or for continuous improvement programs.

  • Develop and deliver against project plans that support technical transfers, APS, new equipment installations.

  • Support and approve technical documents for the IQ/OQ/PQ, UAT Testing, and other equipment or process enhancements.

Safety

  • Takes personal responsibility to work safely and to ensure their managers and WCT members do the same.

  • Performs regular safety Gemba walks, knows the hazards associated with their work and demonstrates safe behavior.

  • Operates and maintains equipment to prevent injuries or incidents.

  • Conducts monthly safety inspections and proactively partners with the EHS team for safety updates, initiatives, or trainings.

  • Provides support for any safety inspections (internal or external) as requested.

  • Acts as a Safety Change Agent supporting safety initiatives and requirements across the site and within WCT.

Documentation

  • Is accountable for the Production Records produced by their Manufacturing Sr. Managers, Managers and WCT members.

  • Performs batch record reviews (BRR) or Electronic Batch Record review by exception.

  • Ensures that all documentation produced by their Sr. Managers, Managers and WCTs follows the ALCOA+ principles.

  • Ensures the documentation produced by their Sr. Managers, Manufacturing Managers and WCT members is right first time, and all records and logbooks are complete and accurate."

  • Addresses all major documentation issues and establishes strategies that reduce documentation errors within their WCT.

Process Expertise

  • Supports Material Review Board (MRB) data collection and provides process expertise when required to support the MRB decision making process.

  • Provides weekend coverage for manufacturing operations and is senior leadership support for any technical or manufacturing issues during weekend coverage.

  • Continues to develop expertise in the field of CAR - T Manufacturing and regulatory requirements that pertain CAR T manufacturing.

Resource Management

  • Is responsible to hire personnel that meet job description criteria and BMS values and sustain the manufacturing culture and that meet budgetary and fiscal requirement.

  • Monitor and maintain the facility resources to ensure calibrations are met, periodic maintenance criteria are met, and facility designs support continuing growth and operational needs for the manufacturing team.

  • Manage and monitor inventory cycle counts during supply shortages and proactively control usage rate.

Priorities

  • Sets their Sr. Managers, Managers and WCTs priorities and adjusts as necessary to track the site and or functional priorities, establishes the WCT goals and is responsible to monitor, measure and assess the performance/completion of the WCT manufacturing activities and goals.

  • Reports out performance metrics and goal progress daily, weekly, monthly in functional and site Tier meetings and the site metric control plans.

  • Capable of managing multiple projects and exceed or at a minimum meet in delivery against deadlines.

Training

  • Ensures that their Manufacturing Managers and their WCTs have the appropriate level of training necessary for CAR-T GMP manufacturing in a multi-product commercial facility.

  • Is responsible to maintain their Manufacturing Sr. Managers, Managers, themselves, and WCTs training compliance at the required 100% on-time completion rate.

  • Ensures that their Manufacturing Sr. Managers, Managers and their WCT members are proficient and qualified to perform the manufacturing tasks before doing so.

  • Monitors team training due dates and maintains the trained status of their Manufacturing Sr. Managers, Managers and WCT members by ensuring appropriate time is allocated to training activities.

  • Immediately disqualifies personnel from GMP tasks if observed to not comply with SOPs, Wis, or batch records, including safety trainings.

  • Actively identifies training needs to increase compliance or technical knowledge and proactively work with the Training & Learning Organization (TLO) to deliver those programs.

Team Building and Development

  • Has proven capability to lead large diverse teams of approximately 100 personnel, supports a diverse thought process, encourages open communication and learning culture.

  • Is responsible to build high performing WCTs comprising of Manufacturing Sr. Managers, Managers, Operators, Team Leads and Supervisors.

  • Recruits exceptional people, conducts interviews, reviews candidates' suitability, and provides meaningful feedback to Talent Acquisition and HR partners during the recruitment process with urgency.

  • Is responsible to create and maintain Workday profiles for all new hired staff.

  • Is responsible to administer the annual performance review process, differentiating performance between team members.

  • Gives recognition when deserved and guidance to improve poor performance or behavior not aligned with the BMS values.

  • Conducts regular 1:1 meeting with each Manufacturing Sr. Manager to mentor, develop and motivate them.

  • Provides periodic 1 over 1 meeting with Managers, Supervisors, Team Leads and WTC members to remain engaged with the team.

  • Cascades relevant company information and takes time to help team members with their professional development including seeking out potential career development opportunities.

  • Creates and maintains a culture of learning via discussion of deviations, safety incidents, and provides meaningful, timely, and accurate coaching during processing.

  • Develops cross-functional relationships with Quality Shop Floor, Warehouse, Supply Chain, Manufacturing Science & Technology, QC Laboratories, QA Doc Control, Training & Learning Organization, Global manufacturing departments, Global Quality and Global Manufacturing Science & Technology teams to sustain, improve, or maintain compliant manufacturing processes.

Deviations

  • Leads troubleshooting activities for their WCTs and is a Deviation Business Process Owner (BPO) or Area Manager Approval or Business Technical Approver (BTA) for deviation approvals occurring for manufacturing.

  • Maintains deviation metrics and ensures deviation awareness for the WCTs across all shifts, Pareto's out worst or repeat causes of deviations and ensures close out of all deviations on time.

  • Works proactively with their Manufacturing Sr. Managers, Managers and WCTs to reduce the number of deviations occurring and to eliminate repeat causes of deviations.

  • Is accountable to drive continuous improvement to prevent repeat deviations.

  • Reports out deviation progress, maintains their deviation metrics, Pareto's out worst or repeat causes of deviations and closes out all deviations on time.

  • Ensures their Manufacturing Sr. Managers and Managers maintain deviation closure rate (on-time - 2 days prior to due date).

  • Provides reinforcement discussion or coaching as needed to build WCT expertise.

CAPAs, Change Controls & Projects

  • Participates, facilitates, and drives meaningful CAPAs, Change Controls and Projects.

  • Implements or holds Sr. Managers and Managers responsible for the implementation of CAPAs prior to due date.

  • Participates in CAPA, Change Control, Capital meetings and defines, agrees, or owns CAPAs, Change Controls or capital projects for manufacturing.

Budgets

  • Effectively controls expenses within their influence (OT, Supplies, T&E).

  • Maintains approval rights for purchases to support daily operations. Complies with BMS fiscal and budgetary protocols and procedures.

  • Develops metrics that demonstrate the meeting of budgets for their WCT.

Meetings

  • Is responsible to facilitate and lead weekly Tier meetings using the site standard Tier meeting tools.

  • Facilitate monthly Manufacturing Performance Review meetings.

  • Is responsible to participate in the weekly Deviation, CAPA, and Change Control meetings to provide status updates on the quality records owned by them.

  • Support the Investigational Review Board Meetings and provide endorsement to deviations.

  • Attends the weekly WAM and the daily cross-functional manufacturing meeting providing summary of previous day activities, successes, or communicates equipment outages or processing delays.

Knowledge & Skills:

  • Extensive knowledge of EHS and cGMPs and the know-how to work and manage within a regulated environment.

  • Demonstrates aptitude for biotechnology principles and manufacturing systems.

  • Demonstrated proficiency in selection of team and effectively managing personnel issues.

  • Adaptable to a fast paced, complex, and ever-changing business environment.

  • Knowledge of lean manufacturing principles required. Green belt certified is a preference.

  • Excellent communication skills (EN).

Basic Requirements:

  • Bachelor's degree in related field is preferred, or equivalent in work experience, and the ability to think and lead strategically. Advanced degree preferred.

  • Minimum of 10 years of relevant pharmaceutical manufacturing experience with 2-3 years of clean room experience.

  • Minimum of 5 years of direct leadership experiences is required.

  • 5 years of regulatory audit experience is required.

  • 2-3 years of working it and managing budgets (to include financial and headcount).

  • 2-3 years of project management.

  • Lean leadership experience. Green belt certification desired.

Working Conditions:

  • Must be able to stand for extended periods of time (6+ hours).

  • Work in areas where handling human blood products (Biosafety Level 2) will be required.

  • Will work in areas with exposure to vapor phase liquid nitrogen.

  • Will work in areas with the presence of strong magnets.

  • Must be able to work nights, weekends, and shift structure.

  • May require aseptic gowning.

The starting compensation for this job is a range from $159,490 to $193,300 plus incentive cash and stock opportunities (based on eligibility).

The starting pay rate takes into account characteristics of the job, such as required skills and where the job is performed.

Final, individual compensation will be decided based on demonstrated experience.

Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit our BMS Careers Site ( .

Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: Medical, pharmacy, dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support. Work-life programs include paid national holidays and optional holidays, Global Shutdown days between Christmas and New Year's holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Parental, caregiver, bereavement, and military leave. Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources. Other perks like tuition reimbursement and a recognition program.

BMSCART, #LI-Onsite

GPS_2025

If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Uniquely Interesting Work, Life-changing Careers

With a single vision as inspiring as Transforming patients' lives through science™ , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol

BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to . Visit careers.bms.com/ ( eeo-accessibility to access our complete Equal Employment Opportunity statement.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information:

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

Company: Bristol-Myers Squibb

Req Number: R1593356

Updated: 2025-07-24 04:17:35.744 UTC

Location: Summit West-NJ

Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.

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Associate Director, CAR-T Manufacturing Operations

07902 Summit, New Jersey Bristol-Myers Squibb

Posted 5 days ago

Job Viewed

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Job Description

Associate Director, CAR-T Manufacturing Operations Associate Director, CAR-T Manufacturing Operations 1 day ago Be among the first 25 applicants Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more careers.bms.com/working-with-us . At Bristol Myers Squibb, we are reimagining the future of cell therapy. With our bold ambition, backed by a best-in-the-industry team and long-term commitment, we are leading the way to unlock the full promise of cell therapy as we strive to put more patients on the path to a cure. If you are ready to challenge yourself, accelerate your career, and give new hope to patients, there's no better place than here at BMS with our Cell Therapy team. The purpose of the Associate Director, Value Stream CAR T Manufacturing role is to manage and provide oversight of a team of Manufacturing Sr. Managers, Managers, and their Work Centered Teams (WCT) operating in shifts over a 24/7 schedule whose primary responsibility is the execution of Cell Therapy manufacturing processes, maintaining a culture of safety, compliance, innovation, and Continuous Improvement within the Manufacturing Operations function. Shift Available Tuesday - Saturday, Onsite Afternoon Shift, 3 p.m. - 11 30 p.m. Responsibilities Values Leads by example and drives their team to adhere to the BMS values of Inclusion, Accountability, Innovation, Urgency and Passion. Leads with empathy while maintaining team accountability. Able to achieve results while creating an engaging, accountable, and learning culture. GMP Is accountable to ensure their Manufacturing Sr. Managers, Managers and their WCT members execute the manufacturing of Cell Therapy products according to Current Good Manufacturing Practices (cGMP's) following the current, approved Standard Operating Procedures (SOPs) and Work Instructions (WIs). Responsible to own, review, author, or approve SOP, WI, master batch records. Responsible for setting strategic direction for the WCT while maintaining or exceeding compliance, budgetary, safety, and technical requirements. Has direct experience and success with Health Authorities and is capable to defend CAR-T manufacturing processes. Provides compliant solutions to technical issues or for continuous improvement programs. Develop and deliver against project plans that support technical transfers, APS, new equipment installations. Support and approve technical documents for the IQ/OQ/PQ, UAT Testing, and other equipment or process enhancements. Safety Takes personal responsibility to work safely and to ensure their managers and WCT members do the same. Performs regular safety Gemba walks, knows the hazards associated with their work and demonstrates safe behavior. Operates and maintains equipment to prevent injuries or incidents. Conducts monthly safety inspections and proactively partners with the EHS team for safety updates, initiatives, or trainings. Provides support for any safety inspections (internal or external) as requested. Acts as a Safety Change Agent supporting safety initiatives and requirements across the site and within WCT. Documentation Is accountable for the Production Records produced by their Manufacturing Sr. Managers, Managers and WCT members. Performs batch record reviews (BRR) or Electronic Batch Record review by exception. Ensures that all documentation produced by their Sr. Managers, Managers and WCTs follows the ALCOA+ principles. Ensures the documentation produced by their Sr. Managers, Manufacturing Managers and WCT members is right first time, and all records and logbooks are complete and accurate." Addresses all major documentation issues and establishes strategies that reduce documentation errors within their WCT. Process Expertise Supports Material Review Board (MRB) data collection and provides process expertise when required to support the MRB decision making process. Provides weekend coverage for manufacturing operations and is senior leadership support for any technical or manufacturing issues during weekend coverage. Continues to develop expertise in the field of CAR - T Manufacturing and regulatory requirements that pertain CAR T manufacturing. Resource Management Is responsible to hire personnel that meet job description criteria and BMS values and sustain the manufacturing culture and that meet budgetary and fiscal requirement. Monitor and maintain the facility resources to ensure calibrations are met, periodic maintenance criteria are met, and facility designs support continuing growth and operational needs for the manufacturing team. Manage and monitor inventory cycle counts during supply shortages and proactively control usage rate. Priorities Sets their Sr. Managers, Managers and WCTs priorities and adjusts as necessary to track the site and or functional priorities, establishes the WCT goals and is responsible to monitor, measure and assess the performance/completion of the WCT manufacturing activities and goals. Reports out performance metrics and goal progress daily, weekly, monthly in functional and site Tier meetings and the site metric control plans. Capable of managing multiple projects and exceed or at a minimum meet in delivery against deadlines. Training Ensures that their Manufacturing Managers and their WCTs have the appropriate level of training necessary for CAR-T GMP manufacturing in a multi-product commercial facility. Is responsible to maintain their Manufacturing Sr. Managers, Managers, themselves, and WCTs training compliance at the required 100% on-time completion rate. Ensures that their Manufacturing Sr. Managers, Managers and their WCT members are proficient and qualified to perform the manufacturing tasks before doing so. Monitors team training due dates and maintains the trained status of their Manufacturing Sr. Managers, Managers and WCT members by ensuring appropriate time is allocated to training activities. Immediately disqualifies personnel from GMP tasks if observed to not comply with SOPs, Wis, or batch records, including safety trainings. Actively identifies training needs to increase compliance or technical knowledge and proactively work with the Training & Learning Organization (TLO) to deliver those programs. Team Building and Development Has proven capability to lead large diverse teams of approximately 100 personnel, supports a diverse thought process, encourages open communication and learning culture. Is responsible to build high performing WCTs comprising of Manufacturing Sr. Managers, Managers, Operators, Team Leads and Supervisors. Recruits exceptional people, conducts interviews, reviews candidates' suitability, and provides meaningful feedback to Talent Acquisition and HR partners during the recruitment process with urgency. Is responsible to create and maintain Workday profiles for all new hired staff. Is responsible to administer the annual performance review process, differentiating performance between team members. Gives recognition when deserved and guidance to improve poor performance or behavior not aligned with the BMS values. Conducts regular 1 1 meeting with each Manufacturing Sr. Manager to mentor, develop and motivate them. Provides periodic 1 over 1 meeting with Managers, Supervisors, Team Leads and WTC members to remain engaged with the team. Cascades relevant company information and takes time to help team members with their professional development including seeking out potential career development opportunities. Creates and maintains a culture of learning via discussion of deviations, safety incidents, and provides meaningful, timely, and accurate coaching during processing. Develops cross-functional relationships with Quality Shop Floor, Warehouse, Supply Chain, Manufacturing Science & Technology, QC Laboratories, QA Doc Control, Training & Learning Organization, Global manufacturing departments, Global Quality and Global Manufacturing Science & Technology teams to sustain, improve, or maintain compliant manufacturing processes. Deviations Leads troubleshooting activities for their WCTs and is a Deviation Business Process Owner (BPO) or Area Manager Approval or Business Technical Approver (BTA) for deviation approvals occurring for manufacturing. Maintains deviation metrics and ensures deviation awareness for the WCTs across all shifts, Pareto's out worst or repeat causes of deviations and ensures close out of all deviations on time. Works proactively with their Manufacturing Sr. Managers, Managers and WCTs to reduce the number of deviations occurring and to eliminate repeat causes of deviations. Is accountable to drive continuous improvement to prevent repeat deviations. Reports out deviation progress, maintains their deviation metrics, Pareto's out worst or repeat causes of deviations and closes out all deviations on time. Ensures their Manufacturing Sr. Managers and Managers maintain deviation closure rate (on-time - 2 days prior to due date). Provides reinforcement discussion or coaching as needed to build WCT expertise. CAPAs, Change Controls & Projects Participates, facilitates, and drives meaningful CAPAs, Change Controls and Projects. Implements or holds Sr. Managers and Managers responsible for the implementation of CAPAs prior to due date. Participates in CAPA, Change Control, Capital meetings and defines, agrees, or owns CAPAs, Change Controls or capital projects for manufacturing. Budgets Effectively controls expenses within their influence (OT, Supplies, T&E). Maintains approval rights for purchases to support daily operations. Complies with BMS fiscal and budgetary protocols and procedures. Develops metrics that demonstrate the meeting of budgets for their WCT. Meetings Is responsible to facilitate and lead weekly Tier meetings using the site standard Tier meeting tools. Facilitate monthly Manufacturing Performance Review meetings. Is responsible to participate in the weekly Deviation, CAPA, and Change Control meetings to provide status updates on the quality records owned by them. Support the Investigational Review Board Meetings and provide endorsement to deviations. Attends the weekly WAM and the daily cross-functional manufacturing meeting providing summary of previous day activities, successes, or communicates equipment outages or processing delays. Knowledge & Skills Extensive knowledge of EHS and cGMPs and the know-how to work and manage within a regulated environment. Demonstrates aptitude for biotechnology principles and manufacturing systems. Demonstrated proficiency in selection of team and effectively managing personnel issues. Adaptable to a fast paced, complex, and ever-changing business environment. Knowledge of lean manufacturing principles required. Green belt certified is a preference. Excellent communication skills (EN). Basic Requirements Bachelor's degree in related field is preferred, or equivalent in work experience, and the ability to think and lead strategically. Advanced degree preferred. Minimum of 10 years of relevant pharmaceutical manufacturing experience with 2-3 years of clean room experience. Minimum of 5 years of direct leadership experiences is required. 5 years of regulatory audit experience is required. 2-3 years of working it and managing budgets (to include financial and headcount). 2-3 years of project management. Lean leadership experience. Green belt certification desired. Working Conditions Must be able to stand for extended periods of time (6+ hours). Work in areas where handling human blood products (Biosafety Level 2) will be required. Will work in areas with exposure to vapor phase liquid nitrogen. Will work in areas with the presence of strong magnets. Must be able to work nights, weekends, and shift structure. May require aseptic gowning. The starting compensation for this job is a range from $159,490 to $93,300 plus incentive cash and stock opportunities (based on eligibility). The starting pay rate takes into account characteristics of the job, such as required skills and where the job is performed. Final, individual compensation will be decided based on demonstrated experience. Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit our BMS Careers Site. Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following Medical, pharmacy, dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support. Work-life programs include paid national holidays and optional holidays, Global Shutdown days between Christmas and New Year's holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Parental, caregiver, bereavement, and military leave. Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources. Other perks like tuition reimbursement and a recognition program. BMSCART, GPS_2025 If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as Transforming patients' lives through science , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. On-site Protocol BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function. BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to . Visit careers.bms.com/ eeo -accessibility to access our complete Equal Employment Opportunity statement. BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters. BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information https //careers.bms.com/california-residents/ Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations. Seniority level Seniority level Not Applicable Employment type Employment type Full-time Job function Job function Engineering and Information Technology Industries Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Bristol Myers Squibb by 2x Get notified about new Director of Manufacturing Operations jobs in Summit, NJ . 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Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr

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Associate Director, CAR-T Manufacturing Operations

84060 Peoa, Utah Bristol-Myers Squibb

Posted 11 days ago

Job Viewed

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Job Description

Associate Director, CAR-T Manufacturing Operations Join to apply for the Associate Director, CAR-T Manufacturing Operations role at Bristol Myers Squibb Associate Director, CAR-T Manufacturing Operations 2 days ago Be among the first 25 applicants Join to apply for the Associate Director, CAR-T Manufacturing Operations role at Bristol Myers Squibb Get AI-powered advice on this job and more exclusive features. Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us . At Bristol Myers Squibb, we are reimagining the future of cell therapy. With our bold ambition, backed by a best-in-the-industry team and long-term commitment, we are leading the way to unlock the full promise of cell therapy as we strive to put more patients on the path to a cure. If you are ready to challenge yourself, accelerate your career, and give new hope to patients, there's no better place than here at BMS with our Cell Therapy team. The purpose of the Associate Director, Value Stream CAR T Manufacturing role is to manage and provide oversight of a team of Manufacturing Sr. Managers, Managers, and their Work Centered Teams (WCT) operating in shifts over a 24/7 schedule whose primary responsibility is the execution of Cell Therapy manufacturing processes, maintaining a culture of safety, compliance, innovation, and Continuous Improvement within the Manufacturing Operations function. Shift Available Tuesday - Saturday, Onsite Afternoon Shift, 3 p.m. - 11:30 p.m. Responsibilities: Values Leads by example and drives their team to adhere to the BMS values of Inclusion, Accountability, Innovation, Urgency and Passion. Leads with empathy while maintaining team accountability. Able to achieve results while creating an engaging, accountable, and learning culture. GMP Is accountable to ensure their Manufacturing Sr. Managers, Managers and their WCT members execute the manufacturing of Cell Therapy products according to Current Good Manufacturing Practices (cGMP's) following the current, approved Standard Operating Procedures (SOPs) and Work Instructions (WIs). Responsible to own, review, author, or approve SOP, WI, master batch records. Responsible for setting strategic direction for the WCT while maintaining or exceeding compliance, budgetary, safety, and technical requirements. Has direct experience and success with Health Authorities and is capable to defend CAR-T manufacturing processes. Provides compliant solutions to technical issues or for continuous improvement programs. Develop and deliver against project plans that support technical transfers, APS, new equipment installations. Support and approve technical documents for the IQ/OQ/PQ, UAT Testing, and other equipment or process enhancements. Safety Takes personal responsibility to work safely and to ensure their managers and WCT members do the same. Performs regular safety Gemba walks, knows the hazards associated with their work and demonstrates safe behavior. Operates and maintains equipment to prevent injuries or incidents. Conducts monthly safety inspections and proactively partners with the EHS team for safety updates, initiatives, or trainings. Provides support for any safety inspections (internal or external) as requested. Acts as a Safety Change Agent supporting safety initiatives and requirements across the site and within WCT. Documentation Is accountable for the Production Records produced by their Manufacturing Sr. Managers, Managers and WCT members. Performs batch record reviews (BRR) or Electronic Batch Record review by exception. Ensures that all documentation produced by their Sr. Managers, Managers and WCTs follows the ALCOA+ principles. Ensures the documentation produced by their Sr. Managers, Manufacturing Managers and WCT members is right first time, and all records and logbooks are complete and accurate." Addresses all major documentation issues and establishes strategies that reduce documentation errors within their WCT. Process Expertise Supports Material Review Board (MRB) data collection and provides process expertise when required to support the MRB decision making process. Provides weekend coverage for manufacturing operations and is senior leadership support for any technical or manufacturing issues during weekend coverage. Continues to develop expertise in the field of CAR - T Manufacturing and regulatory requirements that pertain CAR T manufacturing. Resource Management Is responsible to hire personnel that meet job description criteria and BMS values and sustain the manufacturing culture and that meet budgetary and fiscal requirement. Monitor and maintain the facility resources to ensure calibrations are met, periodic maintenance criteria are met, and facility designs support continuing growth and operational needs for the manufacturing team. Manage and monitor inventory cycle counts during supply shortages and proactively control usage rate. Priorities Sets their Sr. Managers, Managers and WCTs priorities and adjusts as necessary to track the site and or functional priorities, establishes the WCT goals and is responsible to monitor, measure and assess the performance/completion of the WCT manufacturing activities and goals. Reports out performance metrics and goal progress daily, weekly, monthly in functional and site Tier meetings and the site metric control plans. Capable of managing multiple projects and exceed or at a minimum meet in delivery against deadlines. Training Ensures that their Manufacturing Managers and their WCTs have the appropriate level of training necessary for CAR-T GMP manufacturing in a multi-product commercial facility. Is responsible to maintain their Manufacturing Sr. Managers, Managers, themselves, and WCTs training compliance at the required 100% on-time completion rate. Ensures that their Manufacturing Sr. Managers, Managers and their WCT members are proficient and qualified to perform the manufacturing tasks before doing so. Monitors team training due dates and maintains the trained status of their Manufacturing Sr. Managers, Managers and WCT members by ensuring appropriate time is allocated to training activities. Immediately disqualifies personnel from GMP tasks if observed to not comply with SOPs, Wis, or batch records, including safety trainings. Actively identifies training needs to increase compliance or technical knowledge and proactively work with the Training & Learning Organization (TLO) to deliver those programs. Team Building and Development Has proven capability to lead large diverse teams of approximately 100 personnel, supports a diverse thought process, encourages open communication and learning culture. Is responsible to build high performing WCTs comprising of Manufacturing Sr. Managers, Managers, Operators, Team Leads and Supervisors. Recruits exceptional people, conducts interviews, reviews candidates' suitability, and provides meaningful feedback to Talent Acquisition and HR partners during the recruitment process with urgency. Is responsible to create and maintain Workday profiles for all new hired staff. Is responsible to administer the annual performance review process, differentiating performance between team members. Gives recognition when deserved and guidance to improve poor performance or behavior not aligned with the BMS values. Conducts regular 1:1 meeting with each Manufacturing Sr. Manager to mentor, develop and motivate them. Provides periodic 1 over 1 meeting with Managers, Supervisors, Team Leads and WTC members to remain engaged with the team. Cascades relevant company information and takes time to help team members with their professional development including seeking out potential career development opportunities. Creates and maintains a culture of learning via discussion of deviations, safety incidents, and provides meaningful, timely, and accurate coaching during processing. Develops cross-functional relationships with Quality Shop Floor, Warehouse, Supply Chain, Manufacturing Science & Technology, QC Laboratories, QA Doc Control, Training & Learning Organization, Global manufacturing departments, Global Quality and Global Manufacturing Science & Technology teams to sustain, improve, or maintain compliant manufacturing processes. Deviations Leads troubleshooting activities for their WCTs and is a Deviation Business Process Owner (BPO) or Area Manager Approval or Business Technical Approver (BTA) for deviation approvals occurring for manufacturing. Maintains deviation metrics and ensures deviation awareness for the WCTs across all shifts, Pareto's out worst or repeat causes of deviations and ensures close out of all deviations on time. Works proactively with their Manufacturing Sr. Managers, Managers and WCTs to reduce the number of deviations occurring and to eliminate repeat causes of deviations. Is accountable to drive continuous improvement to prevent repeat deviations. Reports out deviation progress, maintains their deviation metrics, Pareto's out worst or repeat causes of deviations and closes out all deviations on time. Ensures their Manufacturing Sr. Managers and Managers maintain deviation closure rate (on-time - 2 days prior to due date). Provides reinforcement discussion or coaching as needed to build WCT expertise. CAPAs, Change Controls & Projects Participates, facilitates, and drives meaningful CAPAs, Change Controls and Projects. Implements or holds Sr. Managers and Managers responsible for the implementation of CAPAs prior to due date. Participates in CAPA, Change Control, Capital meetings and defines, agrees, or owns CAPAs, Change Controls or capital projects for manufacturing. Budgets Effectively controls expenses within their influence (OT, Supplies, T&E). Maintains approval rights for purchases to support daily operations. Complies with BMS fiscal and budgetary protocols and procedures. Develops metrics that demonstrate the meeting of budgets for their WCT. Meetings Is responsible to facilitate and lead weekly Tier meetings using the site standard Tier meeting tools. Facilitate monthly Manufacturing Performance Review meetings. Is responsible to participate in the weekly Deviation, CAPA, and Change Control meetings to provide status updates on the quality records owned by them. Support the Investigational Review Board Meetings and provide endorsement to deviations. Attends the weekly WAM and the daily cross-functional manufacturing meeting providing summary of previous day activities, successes, or communicates equipment outages or processing delays. Knowledge & Skills: Extensive knowledge of EHS and cGMPs and the know-how to work and manage within a regulated environment. Demonstrates aptitude for biotechnology principles and manufacturing systems. Demonstrated proficiency in selection of team and effectively managing personnel issues. Adaptable to a fast paced, complex, and ever-changing business environment. Knowledge of lean manufacturing principles required. Green belt certified is a preference. Excellent communication skills (EN). Basic Requirements: Bachelor's degree in related field is preferred, or equivalent in work experience, and the ability to think and lead strategically. Advanced degree preferred. Minimum of 10 years of relevant pharmaceutical manufacturing experience with 2-3 years of clean room experience. Minimum of 5 years of direct leadership experiences is required. 5 years of regulatory audit experience is required. 2-3 years of working it and managing budgets (to include financial and headcount). 2-3 years of project management. Lean leadership experience. Green belt certification desired. Working Conditions: Must be able to stand for extended periods of time (6+ hours). Work in areas where handling human blood products (Biosafety Level 2) will be required. Will work in areas with exposure to vapor phase liquid nitrogen. Will work in areas with the presence of strong magnets. Must be able to work nights, weekends, and shift structure. May require aseptic gowning. The starting compensation for this job is a range from $159,490 to $193,300 plus incentive cash and stock opportunities (based on eligibility). The starting pay rate takes into account characteristics of the job, such as required skills and where the job is performed. Final, individual compensation will be decided based on demonstrated experience. Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit our BMS Careers Site. Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: Medical, pharmacy, dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support. Work-life programs include paid national holidays and optional holidays, Global Shutdown days between Christmas and New Year's holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Parental, caregiver, bereavement, and military leave. Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources. Other perks like tuition reimbursement and a recognition program. BMSCART, GPS_2025 If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as Transforming patients' lives through science , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. On-site Protocol Responsibilities BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role: Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function. BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to . Visit careers.bms.com/ eeo -accessibility to access our complete Equal Employment Opportunity statement. BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters. BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations. Seniority level Seniority level Director Employment type Employment type Full-time Job function Job function Engineering and Information Technology Industries Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Bristol Myers Squibb by 2x Get notified about new Director of Manufacturing Operations jobs in West Summit, MA . Associate Director, Cell Therapy Manufacturing Systems & MES We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr

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Associate Director, CAR-T Manufacturing Operations

53774 Madison, Wisconsin My Next Stage

Posted 12 days ago

Job Viewed

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Job Description

Working with Us Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us . At Bristol Myers Squibb, we are reimagining the future of cell therapy. With our bold ambition, backed by a best-in-the-industry team and long-term commitment, we are leading the way to unlock the full promise of cell therapy as we strive to put more patients on the path to a cure. If you are ready to challenge yourself, accelerate your career, and give new hope to patients, there’s no better place than here at BMS with our Cell Therapy team. The purpose of the Associate Director, Value Stream CAR T Manufacturing role is to manage and provide oversight of a team of Manufacturing Sr. Managers, Managers, and their Work Centered Teams (WCT) operating in shifts over a 24/7 schedule whose primary responsibility is the execution of Cell Therapy manufacturing processes, maintaining a culture of safety, compliance, innovation, and Continuous Improvement within the Manufacturing Operations function. Shift Available: Tuesday - Saturday, Onsite Afternoon Shift, 3 p.m. - 11:30 p.m. Responsibilities: Values Leads by example and drives their team to adhere to the BMS values of Inclusion, Accountability, Innovation, Urgency and Passion. Leads with empathy while maintaining team accountability. Able to achieve results while creating an engaging, accountable, and learning culture. GMP Is accountable to ensure their Manufacturing Sr. Managers, Managers and their WCT members execute the manufacturing of Cell Therapy products according to Current Good Manufacturing Practices (cGMP’s) following the current, approved Standard Operating Procedures (SOPs) and Work Instructions (WIs). Responsible to own, review, author, or approve SOP, WI, master batch records. Responsible for setting strategic direction for the WCT while maintaining or exceeding compliance, budgetary, safety, and technical requirements. Has direct experience and success with Health Authorities and is capable to defend CAR-T manufacturing processes. Provides compliant solutions to technical issues or for continuous improvement programs. Develop and deliver against project plans that support technical transfers, APS, new equipment installations. Support and approve technical documents for the IQ/OQ/PQ, UAT Testing, and other equipment or process enhancements. Safety Takes personal responsibility to work safely and to ensure their managers and WCT members do the same. Performs regular safety Gemba walks, knows the hazards associated with their work and demonstrates safe behavior. Operates and maintains equipment to prevent injuries or incidents. Conducts monthly safety inspections and proactively partners with the EHS team for safety updates, initiatives, or trainings. Provides support for any safety inspections (internal or external) as requested. Acts as a Safety Change Agent supporting safety initiatives and requirements across the site and within WCT. Documentation Is accountable for the Production Records produced by their Manufacturing Sr. Managers, Managers and WCT members. Performs batch record reviews (BRR) or Electronic Batch Record review by exception. Ensures that all documentation produced by their Sr. Managers, Managers and WCTs follows the ALCOA+ principles. Ensures the documentation produced by their Sr. Managers, Manufacturing Managers and WCT members is right first time, and all records and logbooks are complete and accurate. Addresses all major documentation issues and establishes strategies that reduce documentation errors within their WCT. Process Expertise Supports Material Review Board (MRB) data collection and provides process expertise when required to support the MRB decision making process. Provides weekend coverage for manufacturing operations and is senior leadership support for any technical or manufacturing issues during weekend coverage. Continues to develop expertise in the field of CAR – T Manufacturing and regulatory requirements that pertain CAR T manufacturing. Resource Management Is responsible to hire personnel that meet job description criteria and BMS values and sustain the manufacturing culture and that meet budgetary and fiscal requirement. Monitor and maintain the facility resources to ensure calibrations are met, periodic maintenance criteria are met, and facility designs support continuing growth and operational needs for the manufacturing team. Manage and monitor inventory cycle counts during supply shortages and proactively control usage rate. Priorities Sets their Sr. Managers, Managers and WCTs priorities and adjusts as necessary to track the site and or functional priorities, establishes the WCT goals and is responsible to monitor, measure and assess the performance/completion of the WCT manufacturing activities and goals. Reports out performance metrics and goal progress daily, weekly, monthly in functional and site Tier meetings and the site metric control plans. Capable of managing multiple projects and exceed or at a minimum meet in delivery against deadlines. Training Ensures that their Manufacturing Managers and their WCTs have the appropriate level of training necessary for CAR-T GMP manufacturing in a multi-product commercial facility. Is responsible to maintain their Manufacturing Sr. Managers, Managers, themselves, and WCTs training compliance at the required 100% on-time completion rate. Ensures that their Manufacturing Sr. Managers, Managers and their WCT members are proficient and qualified to perform the manufacturing tasks before doing so. Monitors team training due dates and maintains the trained status of their Manufacturing Sr. Managers, Managers and WCT members by ensuring appropriate time is allocated to training activities. Immediately disqualifies personnel from GMP tasks if observed to not comply with SOPs, Wis, or batch records, including safety trainings. Actively identifies training needs to increase compliance or technical knowledge and proactively work with the Training & Learning Organization (TLO) to deliver those programs. Team Building and Development Has proven capability to lead large diverse teams of approximately 100 personnel, supports a diverse thought process, encourages open communication and learning culture. Is responsible to build high performing WCTs comprising of Manufacturing Sr. Managers, Managers, Operators, Team Leads and Supervisors. Recruits exceptional people, conducts interviews, reviews candidates’ suitability, and provides meaningful feedback to Talent Acquisition and HR partners during the recruitment process with urgency. Is responsible to create and maintain Workday profiles for all new hired staff. Is responsible to administer the annual performance review process, differentiating performance between team members. Gives recognition when deserved and guidance to improve poor performance or behavior not aligned with the BMS values. Conducts regular 1:1 meeting with each Manufacturing Sr. Manager to mentor, develop and motivate them. Provides periodic 1 over 1 meeting with Managers, Supervisors, Team Leads and WTC members to remain engaged with the team. Cascades relevant company information and takes time to help team members with their professional development including seeking out potential career development opportunities. Creates and maintains a culture of learning via discussion of deviations, safety incidents, and provides meaningful, timely, and accurate coaching during processing. Develops cross-functional relationships with Quality Shop Floor, Warehouse, Supply Chain, Manufacturing Science & Technology, QC Laboratories, QA Doc Control, Training & Learning Organization, Global manufacturing departments, Global Quality and Global Manufacturing Science & Technology teams to sustain, improve, or maintain compliant manufacturing processes. Deviations Leads troubleshooting activities for their WCTs and is a Deviation Business Process Owner (BPO) or Area Manager Approval or Business Technical Approver (BTA) for deviation approvals occurring for manufacturing. Maintains deviation metrics and ensures deviation awareness for the WCTs across all shifts, Pareto’s out worst or repeat causes of deviations and ensures close out of all deviations on time. Works proactively with their Manufacturing Sr. Managers, Managers and WCTs to reduce the number of deviations occurring and to eliminate repeat causes of deviations. Is accountable to drive continuous improvement to prevent repeat deviations. Reports out deviation progress, maintains their deviation metrics, Pareto’s out worst or repeat causes of deviations and closes out all deviations on time. Ensures their Manufacturing Sr. Managers and Managers maintain deviation closure rate (on-time – 2 days prior to due date). Provides reinforcement discussion or coaching as needed to build WCT expertise. CAPAs, Change Controls & Projects Participates, facilitates, and drives meaningful CAPAs, Change Controls and Projects. Implements or holds Sr. Managers and Managers responsible for the implementation of CAPAs prior to due date. Participates in CAPA, Change Control, Capital meetings and defines, agrees, or owns CAPAs, Change Controls or capital projects for manufacturing. Budgets Effectively controls expenses within their influence (OT, Supplies, T&E). Maintains approval rights for purchases to support daily operations. Complies with BMS fiscal and budgetary protocols and procedures. Develops metrics that demonstrate the meeting of budgets for their WCT. Meetings Is responsible to facilitate and lead weekly Tier meetings using the site standard Tier meeting tools. Facilitate monthly Manufacturing Performance Review meetings. Is responsible to participate in the weekly Deviation, CAPA, and Change Control meetings to provide status updates on the quality records owned by them. Support the Investigational Review Board Meetings and provide endorsement to deviations. Attends the weekly WAM and the daily cross-functional manufacturing meeting providing summary of previous day activities, successes, or communicates equipment outages or processing delays. Knowledge & Skills: Extensive knowledge of EHS and cGMPs and the know–how to work and manage within a regulated environment. Demonstrates aptitude for biotechnology principles and manufacturing systems. Demonstrated proficiency in selection of team and effectively managing personnel issues. Adaptable to a fast paced, complex, and ever-changing business environment. Knowledge of lean manufacturing principles required. Green belt certified is a preference. Excellent communication skills (EN). Basic Requirements: Bachelor’s degree in related field is preferred, or equivalent in work experience, and the ability to think and lead strategically. Advanced degree preferred. Minimum of 10 years of relevant pharmaceutical manufacturing experience with 2-3 years of clean room experience. Minimum of 5 years of direct leadership experiences is required. 5 years of regulatory audit experience is required. 2-3 years of working it and managing budgets (to include financial and headcount). 2-3 years of project management. Lean leadership experience. Green belt certification desired. Working Conditions: Must be able to stand for extended periods of time (6+ hours). Work in areas where handling human blood products (Biosafety Level 2) will be required. Will work in areas with exposure to vapor phase liquid nitrogen. Will work in areas with the presence of strong magnets. Must be able to work nights, weekends, and shift structure. May require aseptic gowning. The starting compensation for this job is a range from $159,490 to $193,300 plus incentive cash and stockopportunities (based on eligibility). The starting pay rate takes into account characteristics of the job, such as required skills and where the job is performed. Final, individual compensation will be decided based on demonstrated experience. Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit our BMS Careers Site . Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: Medical,pharmacy, dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP).Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability, life insurance, supplementalhealth insurance, business travel protection and survivor support. Work-life programs include paid national holidays and optional holidays,Global Shutdown days between Christmas and New Year’s holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Parental, caregiver, bereavement, and military leave. Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources. Other perks liketuition reimbursement and a recognition program. BMSCART, #LI-Onsite GPS_2025 If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as “Transforming patients’ lives through science ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. On-site Protocol BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role: Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function. BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to . Visit careers.bms.com/ eeo -accessibility to access our complete Equal Employment Opportunity statement. BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters. BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations. #J-18808-Ljbffr

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Associate Director, CAR-T Manufacturing Operations

07901 Summit, New Jersey Bristol Myers Squibb

Posted today

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Job Description

**Working with Us**
Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us .
At Bristol Myers Squibb, we are reimagining the future of cell therapy. With our bold ambition, backed by a best-in-the-industry team and long-term commitment, we are leading the way to unlock the full promise of cell therapy as we strive to put more patients on the path to a cure. If you are ready to challenge yourself, accelerate your career, and give new hope to patients, there's no better place than here at BMS with our Cell Therapy team.
The purpose of the Associate Director, Value Stream CAR T Manufacturing role is to manage and provide oversight of a team of Manufacturing Sr. Managers, Managers, and their Work Centered Teams (WCT) operating in shifts over a 24/7 schedule whose primary responsibility is the execution of Cell Therapy manufacturing processes, maintaining a culture of safety, compliance, innovation, and Continuous Improvement within the Manufacturing Operations function.
**Shift Available:**
+ Tuesday - Saturday, Onsite Afternoon Shift, 3 p.m. - 11:30 p.m.
**Responsibilities:**
**Values**
+ Leads by example and drives their team to adhere to the BMS values of Inclusion, Accountability, Innovation, Urgency and Passion.
+ Leads with empathy while maintaining team accountability.
+ Able to achieve results while creating an engaging, accountable, and learning culture.
**GMP**
+ Is accountable to ensure their Manufacturing Sr. Managers, Managers and their WCT members execute the manufacturing of Cell Therapy products according to Current Good Manufacturing Practices (cGMP's) following the current, approved Standard Operating Procedures (SOPs) and Work Instructions (WIs).
+ Responsible to own, review, author, or approve SOP, WI, master batch records.
+ Responsible for setting strategic direction for the WCT while maintaining or exceeding compliance, budgetary, safety, and technical requirements.
+ Has direct experience and success with Health Authorities and is capable to defend CAR-T manufacturing processes.
+ Provides compliant solutions to technical issues or for continuous improvement programs.
+ Develop and deliver against project plans that support technical transfers, APS, new equipment installations.
+ Support and approve technical documents for the IQ/OQ/PQ, UAT Testing, and other equipment or process enhancements.
**Safety**
+ Takes personal responsibility to work safely and to ensure their managers and WCT members do the same.
+ Performs regular safety Gemba walks, knows the hazards associated with their work and demonstrates safe behavior.
+ Operates and maintains equipment to prevent injuries or incidents.
+ Conducts monthly safety inspections and proactively partners with the EHS team for safety updates, initiatives, or trainings.
+ Provides support for any safety inspections (internal or external) as requested.
+ Acts as a Safety Change Agent supporting safety initiatives and requirements across the site and within WCT.
**Documentation**
+ Is accountable for the Production Records produced by their Manufacturing Sr. Managers, Managers and WCT members.
+ Performs batch record reviews (BRR) or Electronic Batch Record review by exception.
+ Ensures that all documentation produced by their Sr. Managers, Managers and WCTs follows the ALCOA+ principles.
+ Ensures the documentation produced by their Sr. Managers, Manufacturing Managers and WCT members is right first time, and all records and logbooks are complete and accurate."
+ Addresses all major documentation issues and establishes strategies that reduce documentation errors within their WCT.
**Process Expertise**
+ Supports Material Review Board (MRB) data collection and provides process expertise when required to support the MRB decision making process.
+ Provides weekend coverage for manufacturing operations and is senior leadership support for any technical or manufacturing issues during weekend coverage.
+ Continues to develop expertise in the field of CAR - T Manufacturing and regulatory requirements that pertain CAR T manufacturing.
**Resource Management**
+ Is responsible to hire personnel that meet job description criteria and BMS values and sustain the manufacturing culture and that meet budgetary and fiscal requirement.
+ Monitor and maintain the facility resources to ensure calibrations are met, periodic maintenance criteria are met, and facility designs support continuing growth and operational needs for the manufacturing team.
+ Manage and monitor inventory cycle counts during supply shortages and proactively control usage rate.
**Priorities**
+ Sets their Sr. Managers, Managers and WCTs priorities and adjusts as necessary to track the site and or functional priorities, establishes the WCT goals and is responsible to monitor, measure and assess the performance/completion of the WCT manufacturing activities and goals.
+ Reports out performance metrics and goal progress daily, weekly, monthly in functional and site Tier meetings and the site metric control plans.
+ Capable of managing multiple projects and exceed or at a minimum meet in delivery against deadlines.
**Training**
+ Ensures that their Manufacturing Managers and their WCTs have the appropriate level of training necessary for CAR-T GMP manufacturing in a multi-product commercial facility.
+ Is responsible to maintain their Manufacturing Sr. Managers, Managers, themselves, and WCTs training compliance at the required 100% on-time completion rate.
+ Ensures that their Manufacturing Sr. Managers, Managers and their WCT members are proficient and qualified to perform the manufacturing tasks before doing so.
+ Monitors team training due dates and maintains the trained status of their Manufacturing Sr. Managers, Managers and WCT members by ensuring appropriate time is allocated to training activities.
+ Immediately disqualifies personnel from GMP tasks if observed to not comply with SOPs, Wis, or batch records, including safety trainings.
+ Actively identifies training needs to increase compliance or technical knowledge and proactively work with the Training & Learning Organization (TLO) to deliver those programs.
**Team Building and Development**
+ Has proven capability to lead large diverse teams of approximately 100 personnel, supports a diverse thought process, encourages open communication and learning culture.
+ Is responsible to build high performing WCTs comprising of Manufacturing Sr. Managers, Managers, Operators, Team Leads and Supervisors.
+ Recruits exceptional people, conducts interviews, reviews candidates' suitability, and provides meaningful feedback to Talent Acquisition and HR partners during the recruitment process with urgency.
+ Is responsible to create and maintain Workday profiles for all new hired staff.
+ Is responsible to administer the annual performance review process, differentiating performance between team members.
+ Gives recognition when deserved and guidance to improve poor performance or behavior not aligned with the BMS values.
+ Conducts regular 1:1 meeting with each Manufacturing Sr. Manager to mentor, develop and motivate them.
+ Provides periodic 1 over 1 meeting with Managers, Supervisors, Team Leads and WTC members to remain engaged with the team.
+ Cascades relevant company information and takes time to help team members with their professional development including seeking out potential career development opportunities.
+ Creates and maintains a culture of learning via discussion of deviations, safety incidents, and provides meaningful, timely, and accurate coaching during processing.
+ Develops cross-functional relationships with Quality Shop Floor, Warehouse, Supply Chain, Manufacturing Science & Technology, QC Laboratories, QA Doc Control, Training & Learning Organization, Global manufacturing departments, Global Quality and Global Manufacturing Science & Technology teams to sustain, improve, or maintain compliant manufacturing processes.
**Deviations**
+ Leads troubleshooting activities for their WCTs and is a Deviation Business Process Owner (BPO) or Area Manager Approval or Business Technical Approver (BTA) for deviation approvals occurring for manufacturing.
+ Maintains deviation metrics and ensures deviation awareness for the WCTs across all shifts, Pareto's out worst or repeat causes of deviations and ensures close out of all deviations on time.
+ Works proactively with their Manufacturing Sr. Managers, Managers and WCTs to reduce the number of deviations occurring and to eliminate repeat causes of deviations.
+ Is accountable to drive continuous improvement to prevent repeat deviations.
+ Reports out deviation progress, maintains their deviation metrics, Pareto's out worst or repeat causes of deviations and closes out all deviations on time.
+ Ensures their Manufacturing Sr. Managers and Managers maintain deviation closure rate (on-time - 2 days prior to due date).
+ Provides reinforcement discussion or coaching as needed to build WCT expertise.
**CAPAs, Change Controls & Projects**
+ Participates, facilitates, and drives meaningful CAPAs, Change Controls and Projects.
+ Implements or holds Sr. Managers and Managers responsible for the implementation of CAPAs prior to due date.
+ Participates in CAPA, Change Control, Capital meetings and defines, agrees, or owns CAPAs, Change Controls or capital projects for manufacturing.
**Budgets**
+ Effectively controls expenses within their influence (OT, Supplies, T&E).
+ Maintains approval rights for purchases to support daily operations. Complies with BMS fiscal and budgetary protocols and procedures.
+ Develops metrics that demonstrate the meeting of budgets for their WCT.
**Meetings**
+ Is responsible to facilitate and lead weekly Tier meetings using the site standard Tier meeting tools.
+ Facilitate monthly Manufacturing Performance Review meetings.
+ Is responsible to participate in the weekly Deviation, CAPA, and Change Control meetings to provide status updates on the quality records owned by them.
+ Support the Investigational Review Board Meetings and provide endorsement to deviations.
+ Attends the weekly WAM and the daily cross-functional manufacturing meeting providing summary of previous day activities, successes, or communicates equipment outages or processing delays.
**Knowledge & Skills:**
+ Extensive knowledge of EHS and cGMPs and the know-how to work and manage within a regulated environment.
+ Demonstrates aptitude for biotechnology principles and manufacturing systems.
+ Demonstrated proficiency in selection of team and effectively managing personnel issues.
+ Adaptable to a fast paced, complex, and ever-changing business environment.
+ Knowledge of lean manufacturing principles required. Green belt certified is a preference.
+ Excellent communication skills (EN).
**Basic Requirements:**
+ Bachelor's degree in related field is preferred, or equivalent in work experience, and the ability to think and lead strategically. Advanced degree preferred.
+ Minimum of 10 years of relevant pharmaceutical manufacturing experience with 2-3 years of clean room experience.
+ Minimum of 5 years of direct leadership experiences is required.
+ 5 years of regulatory audit experience is required.
+ 2-3 years of working it and managing budgets (to include financial and headcount).
+ 2-3 years of project management.
+ Lean leadership experience. Green belt certification desired.
**Working Conditions:**
+ Must be able to stand for extended periods of time (6+ hours).
+ Work in areas where handling human blood products (Biosafety Level 2) will be required.
+ Will work in areas with exposure to vapor phase liquid nitrogen.
+ Will work in areas with the presence of strong magnets.
+ Must be able to work nights, weekends, and shift structure.
+ May require aseptic gowning.
The starting compensation for this job is a range from $159,490 to $193,300 plus incentive cash and stock opportunities (based on eligibility).
The starting pay rate takes into account characteristics of the job, such as required skills and where the job is performed.
Final, individual compensation will be decided based on demonstrated experience.
Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit our BMS Careers Site ( .
Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: Medical, pharmacy, dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support. Work-life programs include paid national holidays and optional holidays, Global Shutdown days between Christmas and New Year's holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Parental, caregiver, bereavement, and military leave. Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources. Other perks like tuition reimbursement and a recognition program.
BMSCART, #LI-Onsite
GPS_2025
If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
**Uniquely Interesting Work, Life-changing Careers**
With a single vision as inspiring as Transforming patients' lives through science , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
**On-site Protocol**
BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to . Visit careers.bms.com/ ( eeo-accessibility to access our complete Equal Employment Opportunity statement.
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
**Company:** Bristol-Myers Squibb
**Req Number:** R1593356
**Updated:** 2025-07-24 04:17:35.744 UTC
**Location:** Summit West-NJ
Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.
View Now

Senior Manager, CAR-T Manufacturing Operations

07901 Summit, New Jersey Bristol Myers Squibb

Posted today

Job Viewed

Tap Again To Close

Job Description

**Working with Us**
Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us .
**Job Title** : Senior Manager, Liso-cel CAR-T, Manufacturing Operations
Department: Value Stream CAR-T Manufacturing Operations
Location: US-NJ-Summit West, S12
**Position Summary:**
We are seeking a Senior Manager to oversee a dynamic team of Manufacturing Managers in a 24/7 Cell Therapy operation. The role involves ensuring the execution of key manufacturing processes with a focus on safety, compliance, innovation, and continuous improvement. This position reports to the Associate Director of Manufacturing.
**Key Responsibilities:**
+ **Leadership & Values:** Set an example by leading teams that uphold BMS values of Inclusion, Accountability, Innovation, Urgency, and Passion. Conduct regular 1:1 meetings to mentor and develop the team.
+ **GMP Compliance:** Oversee the manufacturing of cell therapy products in line with cGMP standards and SOPs. Involve yourself in writing and approving SOPs and work instructions.
+ **Safety & Documentation:** Maintain a safety-first culture by conducting safety walks, operating equipment safely, and ensuring meticulous documentation that aligns with ALCOA+ principles.
+ **Team Development & Building:** Recruit, mentor, and assess performance of team members. Create a culture of learning and professional development by addressing deviations and recognizing achievements.
+ **Deviations & Compliance:** Lead deviation reviews, approve records, and ensure timely resolution to prevent recurrence. Engage in CAPA, Change Controls, and relevant projects to enhance process compliance.
+ **Resource Management:** Manage scheduling and resources, adjust priorities to align with business objectives, and provide performance metrics and updates regularly.
+ **Training:** Ensure all team members are trained and compliant with CAR-T GMP manufacturing standards. Maintain 100% on-time training completion.
**Qualifications:**
+ **Education & Experience:** Bachelor's degree preferred; advanced degree a plus. Must have 7+ years of relevant manufacturing experience and at least 5 years in a leadership role with direct reports.
+ **Skills:** Strong knowledge of EHS and cGMPs, ability to manage in a regulated environment, proficiency in biotechnology principles, experience with lean manufacturing (green belt preferred), and excellent communication skills.
+ **Working Conditions:** Comfortable in controlled environments, compliant with safety attire requirements, capable of lifting up to 25 lbs, and able to work around human blood components.
This is a pivotal role for a proactive leader eager to drive excellence in the manufacturing of cell therapies at BMS.
The starting compensation for this job is a range from $119,000 - $149,000, plus incentive cash and stock opportunities (based on eligibility). The starting pay rate takes into account characteristics of the job, such as required skills and the geographic location where work is performed. Final, individual compensation is decided commensurate with demonstrated experience. For more on benefits, please visit our BMS Careers Site. Eligibility for specific benefits listed therein may vary based on job and location.
Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: Medical, pharmacy, dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support. Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year's holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Parental, caregiver, bereavement, and military leave. Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources. Other perks like tuition reimbursement and a recognition program.
If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
**Uniquely Interesting Work, Life-changing Careers**
With a single vision as inspiring as Transforming patients' lives through science , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
**On-site Protocol**
BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to . Visit careers.bms.com/ ( eeo-accessibility to access our complete Equal Employment Opportunity statement.
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
**Company:** Bristol-Myers Squibb
**Req Number:** R1593475
**Updated:** 2025-07-24 04:17:35.111 UTC
**Location:** Summit West-NJ
Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.
View Now

Senior Manager, CAR T Manufacturing Records and Procedures

07901 Summit, New Jersey Bristol Myers Squibb

Posted today

Job Viewed

Tap Again To Close

Job Description

**Working with Us**
Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us .
A t **Bristol Myers Squibb** we are reimagining the future of cell therapy. With our bold ambition, backed by a best-in-the-industry team and long-term commitment, we are leading the way to unlock the full promise of cell therapy as we strive to put more patients on the path to a cure. If you are ready to challenge yourself, accelerate your career, and give new hope to patients, there's no better place than here at BMS with our Cell Therapy team.
The senior manager is responsible to manage and provide oversight of a team. Primary responsibilities are to attend IRB, CRB, CCRB, and MEB and own actions presented as applicable, support deviations and triage calls for Investigations as required, implement appropriate quality record actions, and author, review and approve technical and procedural documents. The senior manager provides leadership and guidance to their managers and technical writers while maintaining a culture of safety, compliance, innovation and continuous improvement within the Value Stream Support Operations function.
**Shift Available:**
+ Monday - Friday, Onsite Day Shift, 8 a.m. - 4:30 p.m.
**Responsibilities:**
+ Maintain balanced and unbiased functional relationships, championing a culture of exceptional teamwork and communication across the organization.
+ Identifying and where possible mitigating risks in manufacturing operations that could negatively impact delivery of safe and effective therapies to patients.
+ Develop their team through scheduled coaching sessions.
+ Instill proper problem identification behaviors.
+ Acknowledge ideas and/or issues with feedback on path forward.
+ Coordinate across the value stream to align with appropriate goals and objectives.
+ Ability to breakdown larger goals to goals that can be influenced.
+ Escalate issues at the appropriate level of urgency.
+ Participate, lead, or coach Go & See (Gemba) activities in their areas for current state understanding, process confirmation, waste reduction, increased flow, continuous improvement idea generation, coaching, or employee engagement.
+ Lead, coach or participate in Improvement & Coaching Kata at Tier Board Meetings, at the department's work area, or with individual team members to creatively experiment and deliver practical improvements to gaps to target.
+ Support their team by removing bottlenecks to problem-solving efforts and/or escalating problems or communicating resolutions through Tiered Management process.
+ Communicate expectations for the usage of Improvement/Coaching Kata, Go & See.
+ Engaged and aligned in communicating and driving performance, issues, accountability and solving problems using the designed tiered management processes.
+ Create and continuously improve their Leader Standard Work for daily, weekly, quarterly, yearly critical tasks, run the business & improve the business activities.
+ Take personal responsibility to work safely and ensure colleagues do the same.
+ Be the champion for continuous improvement.
+ Be purposefully present in the work area.
+ Develop a deep ownership and understanding of one's work area.
+ Establish performance measures and targets to drive improvements.
+ Participate in reviews of performance, generate improvement ideas and take action.
+ Use visual management so no problem is hidden.
+ Build a culture of finding root causes and take action to prevent them from recurring.
+ Know the value stream for the product/service you are providing to your customers.
+ Use actual results to identify waste, reduce variation and improve productivity.
**Knowledge & Skills:**
+ Extensive knowledge of EHS and cGMPs and the know-how to work and manage within a regulated environment.
+ Demonstrates aptitude for biotechnology principles and manufacturing systems.
+ Demonstrated proficiency in selection of team and effectively managing personnel issues.
+ Adaptable to a fast paced, complex and ever-changing business environment.
+ Knowledge of lean manufacturing principles required. Green belt certified is a preference.
+ Excellent communication skills.
**Basic Requirements:**
+ Bachelor's degree in related field is preferred, or equivalent in work experience, and the ability to think and lead strategically. Advanced degree preferred.
+ 5+ years of relevant pharmaceutical manufacturing experience.
+ Minimum of 3 years leadership experiences including the management of direct reports required.
+ Minimum of 3 years technical writing experience is required.
**Working Conditions:**
+ On site presence is based on business need and will be communicated by Associate Director, Value Stream Manufacturing Technical Support.
+ Work is performed in a typical office environment, with standard office equipment available and used.
+ Occasional work, meetings and investigations in a cleanroom environment that requires gowning.
The starting compensation for this job is a range from $127,780 to $154,800 plus incentive cash and stock opportunities (based on eligibility).
The starting pay rate takes into account characteristics of the job, such as required skills and where the job is performed.
Final, individual compensation will be decided based on demonstrated experience.
Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit our BMS Careers Site ( .
Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: Medical,
pharmacy, dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP).
Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support. Work-life programs include paid national holidays and optional holidays, Global Shutdown days between Christmas and New Year's holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Parental, caregiver, bereavement, and military leave. Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources. Other perks like tuition reimbursement and a recognition program.
BMSCART, #LI-Onsite
**GPS_2025**
If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
**Uniquely Interesting Work, Life-changing Careers**
With a single vision as inspiring as Transforming patients' lives through science , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
**On-site Protocol**
BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to . Visit careers.bms.com/ ( eeo-accessibility to access our complete Equal Employment Opportunity statement.
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
**Company:** Bristol-Myers Squibb
**Req Number:** R1592473
**Updated:** 2025-07-24 04:17:35.744 UTC
**Location:** Summit West-NJ
Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.
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