8 Manufacturing jobs in Chocowinity
Sr Manager, Continuous Manufacturing
Posted 1 day ago
Job Viewed
Job Description
Standard (Mon-Fri)
**Environmental Conditions**
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)
**Job Description**
**Job Summary:**
Leads the Manufacturing Sciences Teams and provides strategic direction and mentorship in the areas of manufacturing processes and technology, process improvement, quality performance and formulation development.
Lead and coordinate Operations for the Continuous Manufacturing Dept. Provide technical and managerial mentorship while implementing operational strategies. Collaborate with business unit leaders to support overall client and business unit goals.
Essential Functions
+ Provides leadership to assigned staff through leading organizational change, empowerment, cultivates relationships; helps them achieve their personal career goals while also achieving organizational goals.
+ Builds effective teams that apply their diverse skills and perspectives to achieve common goals; driving engagement and creating a climate where staff are motivated to do their best.
+ Ensures the rapid development of new dosage forms and processes according to customer requirements. Assures that processes are safe, reproducible, cost effective, environmentally sound and can be successfully validated and transferred to production operations, in order to meet agreed standards and require minimal continuing support.
+ Defines resource needs (capital, expense, and headcount) so that current and future development needs are met. Recruits, hires, retains, trains, and motivates a scientifically proficient staff. Provides opportunities for staff career development.
+ Ensure all production operations and equipment are controlled, validated, and in regulatory compliance and appropriate Standard Operating Procedures (SOPs) and batch record documents exist and are followed and reviewed regularly.
+ Technical representation on new business quotes and senior-level client visitors and inter-site visitors. Leads development and coordination of realistic proposals and timelines, reviews technical packages. Leads meetings/teleconferences with clients.
+ Performs all duties in strict compliance with Standard Operating Procedures, Good Manufacturing Practices, Good Laboratory Practices and Safety guidelines.
+ Works with Client Departments to introduce new technology and resolve complex OSD problems related to both existing portfolio and development work.
+ Leads research of industry practices and processes and applies to innovative drug development internally and for client products. Presents recommendations internally and to clients. Publicizes research, scientific reports and white papers. Represents the organization on formal technical and scientific forums.
+ Recommends and assists in implementing organizational and technical improvements designed to enhance the efficiency, reliability, and productivity of operations all conforming to applicable regulatory standards.
+ Tracks quality performance trends and keeps Corrective Action Preventative Action (CAPA) actions on track.
**Education:**
+ PHD in engineering or relevant physical science is preferred
+ Bachelor's of Science in Chemistry, Biochemistry, Biology, or related physical science required.
**Experience:**
+ Minimum 5 years of Oral solid dose manufacturing experience
+ Minimum 5 years of management experience
+ Minimum 10 years of progressive scientific experience, including 9 years in a related life sciences field.
+ Experience working directly with clients
+ Previous Continuous Manufacturing Experience preferred
+ Experience with Process Analytical Technology ( **PAT** ) preferred
**Equivalency:**
Equivalent combinations of education, training, and meaningful work experience may be considered.
**Competencies:**
Ability to drive functional, technical and operational excellence.
Ability to inspire and champion innovation, collaboration, transparency and team effectiveness.
Exceptional Good Manufacturing Practices knowledge.
Demonstrated decision making capabilities.
Strong leadership and conflict resolution skills.
Consistent track record to balance/maintain goals, responsibilities, and priorities of the organization.
Demonstrated success as agent of change.
Excellent interpersonal and communication skills, as well as the ability to empower and lead.
Working knowledge of Microsoft (MS) Office Applications (Word, Excel, PowerPoint, Share point)
Proficiency with the English language.
Demonstrated commitment to our fundamental principles of Integrity, Respect & Excellence.
**Physical Requirements:**
Position requires ordinary ambulatory skills and physical coordination sufficient to move about office locations; ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time; manipulation (lift, carry, move) of light to medium weights of 10-35 pound pounds; arm, hand and finger dexterity, including ability to grasp and type for prolonged periods of time; visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time; ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time.
Relocation assistance is NOT provided.
Must be legally authorized to work in the United States without sponsorship, now or in the future.
Must be able to pass a comprehensive background check, which includes a drug screening.
Disclaimer:
This job description is intended to present the general content and requirements for the performance of this job. The description is not to be construed as an exhaustive statement of duties, responsibilities, or requirements. Managers and supervisors may assign other duties as needed.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
Manufacturing Planner/Scheduler II

Posted 15 days ago
Job Viewed
Job Description
Standard (Mon-Fri)
**Environmental Conditions**
Office
**Job Description**
As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world's toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.
**Excellent Benefits Package**
Review our company's Total Rewards ( Dental, & Vision benefits-effective Day 1
Paid Time Off & Holidays
401K Company Match up to 6%
Tuition Reimbursement - eligible after 90 days!
Employee Referral Bonus
Employee Discount Program
Recognition Program
Charitable Gift Matching
Company Paid Parental Leave
Career Advancement Opportunities
**Location/Division Specific Information**
Greenville, NC
**RE** **LOCATION ASSISTANCE IS NOT PROVIDED**
+ **Must be legally authorized to work in the United States WITHOUT SPONSORSHIP OF ANY KIND NOW OR IN THE FUTURE.**
+ **must be able to pass a comprehensive background check, which includes a drug screen.**
We have industry-leading sterile injectable facilities providing solutions to take essential products from pre-clinical to the market. Pharmaceutical products come in many different dose forms including inhalations, oral dose, cream/ointment and injectables.
**Essential Functions:**
+ Assess the viability of specific Manufacturing/Packaging (MFG / PKG) timetables according to Master Production Scheduling (MPS) or equivalent experience and Material Requirements Planning (MRP).
+ Complete risk assessments and reduce risks to ensure necessary delivery performance.
+ Check production readiness and material availability, initiating related actions when necessary.
+ Resolve short-term MFG / PKG planning challenges.
+ Allocate planned production to production lines, including maintenance and development blocks.
+ Share detailed manufacturing and packaging schedules with key collaborators.
+ Arrange manufacturing orders in line with the provided MFG/PKG schedule, referring to the approved Bill of Materials (BOM).
+ Timely delivery of work orders and associated directives to Production.
+ Update OTOS board and participate in daily MFG / PKG OTOS meetings.
+ Follow up on work orders and samples that were not finished punctually.
+ Work safely and responsibly to maintain an injury-free and incident-free workplace, aligning with all safety and job-related training requirements.
+ Complete additional tasks as delegated.
**Education:**
A bachelor's degree in Operations Management, Logistics, Industrial Engineering, or Industrial Technology or equivalent experience is required.
**Experience:**
Three years of relevant experience in Planning/Buying, Scheduling, Industrial Engineering, Operations, Purchasing, or Quality Assurance (QA) is preferred.
**Equivalency:**
Equivalent combinations of education, training, and relevant work experience may be considered.
**Proficiencies:**
+ Strong understanding of planning functions relative to manufacturing process capabilities.
+ Knowledge of inventory control techniques and planning functions related to CPS, MPS, MRP, and interfacing systems.
+ Familiarity with Marketing requirements concerning process capabilities.
+ Attend APICS's training courses related to scheduling.
+ Ability to engage with different fields and address conflicts.
+ Outstanding attention to detail and organizational skills.
+ Self-starter, mature, independent, and dependable.
+ Skilled at performing well in a high-energy atmosphere, managing various responsibilities, and achieving desired outcomes.
+ Highly effective verbal and written communication skills.
+ Effective time management and prioritization skills.
+ Requires discretion and independent judgment.
+ Demonstrated ability to manage and lead professional staff to achieve goals and resolve complex technical problems.
+ Ability to motivate, energize, and retain key staff through direct interactions with supervisors and staff.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
Sr. Manufacturing Equipment Maintenance Tech
Posted 8 days ago
Job Viewed
Job Description
**Location:** Greenville, NC
**Schedule:** Rotating
**Length:** 6+ month
+ Operate and maintain boiler systems, and all related physical plant equipment, including condenser water (cooling tower) and air compressors, air dryers, Potable water and chilled water systems, per SOPs, cGMPs, and user department requirements
+ Operate and maintain High Purity Water systems- including WFI, PFW, generated by Ros and Distillation units
+ Monitor performance through computer controls and reviewing recorded operating data.
+ Resolve issues to ensure continuous operations and communication status, including failures/corrective actions and readiness to management.
+ Maintain housekeeping services in utilities areas and communicate concerns.
+ Work Rotational shifts including days, nights, weekends, holidays and some non-scheduled days.
**Education:**
+ High school diploma or equivalent required.
+ Associate's degree in applied science in related field - not required but preferred
**Experience:**
+ Required: Minimum of 2 years of work experience in plant equipment operations including boiler operations, air compressors, or related field
+ Preferred: Experience in a cGMP environment
**Knowledge, Skills, Abilities:**
+ Skilled in problem analysis, planning and organization.
+ Strong attention to detail, oral and written communication skills.
+ Proficient in the use of highly technical diagnostic and test equipment.
+ Reading and comprehension of blueprints, manuals and training materials.
+ General trades' knowledge, i.e. HVAC, electrical, mechanical tasks, etc.
**Physical Requirements / Work Environment**
+ **Work in mechanical spaces which may not be controlled and outside work is required at times**
+ Wear gowning which includes gloves, hair & beard net and face cover, safety glasses with no makeup / jewelry, and the like.
+ Use Personal Protective Equipment (PPE) and understand chemical hygiene.
+ Infrequently lift and manipulate up to 25 pounds max unassisted.
+ Stand and move about including reaching, bending, stooping, grasping.
+ Use hand tools and equipment including forceful gripping, grasping, pushing and pulling.
+ Position requires ordinary ambulatory skills and physical coordination sufficient to move about office locations; ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time; manipulation (lift, carry, move) of light to medium weights of 10-35 pounds.
+ Ability to climb ladders and work at heights
As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here ( for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.
Why Kelly ® Engineering?
Your engineering skills are in demand, but how do you find the right fit? Easy. At Kelly Engineering, our team creates expert talent solutions to solve the world's most critical challenges. We connect you with leading organizations where you can collaborate on innovative projects, work with cutting-edge technologies and accelerate your growth. Whether you prefer the variety and flexibility of short-term projects or are looking for a long-term opportunity, we're here to guide you to the next step in your engineering career.
About Kelly
Work changes everything. And at Kelly, we're obsessed with where it can take you. To us, it's about more than simply accepting your next job opportunity. It's the fuel that powers every next step of your life. It's the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life-just ask the 300,000 people we employ each year.
Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.
Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly's Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.
Director, Manufacturing Science and Technology

Posted 15 days ago
Job Viewed
Job Description
Standard (Mon-Fri)
**Environmental Conditions**
Office
**Job Description**
**Position: Director, Manufacturing Science and Technology (MSAT)**
**Reports To: Site Vice President and General Manager**
**Location: Greenville, NC**
**How will you make an impact?**
The MSAT Director provides scientific leadership to ensure compliance, resilience & competitiveness of Thermo Fisher's commercialized Grow, Value Optimization and Late Lifecycle portfolio.
The successful candidate is a Subject Matter Expert (SME) in Large and Small Molecule Drug Products and directs a team of Molecular Biologists, Chemical & Process Engineers, and Scientists. This team leads strategic, tactical and operational technical projects for the commercialized product portfolio, working closely with operations, QA, QC, and various supply chain and development functions. This role builds strong partnerships with functions such as Sales, Business Marketing, Quality, Planning, Regulatory, Procurement etc.
This leader has a strong scientific background and drives successful commercialization of the current and future portfolio. They ensure successful New Product Introduction by prioritizing resources. The team manages Life Cycle Management projects, such as supply chain resilience, process optimization, and innovative improvements for efficiency, competitiveness, compliance, and health authority advocacy.
The Director possesses a strong approach for people leadership and talent development resulting in the continuous uplift in team technical capability and project delivery excellence.
**What will you do?**
Own the site's technical continuous improvement strategy in collaboration with Site Leadership.
Encourage a team supporting projects at all stages of the product life cycle, delivering the following aspects:
+ Budget responsibility for team and related activities
+ Define and own lab experiments
+ Post PPQ, full ownership of all continuous process validation activities
+ Lead and coordinate large-scale technical projects from initiation to completion, defining scope, objectives, actions, timelines, and budget, and collaborating with cross-functional teams for successful execution.
Prioritize projects to support supply chain and the value optimization targets.
Lead strategic change management initiatives, engaging and influencing key partners at all levels of the organization. Develop and implement communication plans for successful adoption and implementation.
**How will you get here**
+ Master's degree in engineering, science, or a related field, or PhD.
+ 10 years of expertise in pharmaceutical processes, including DP characterization, stability profile understanding, and linking DP characteristics with bio-pharmaceutical performance.
+ A minimum of 5 years people leader experience, including technical and non-technical coaching and mentoring.
+ Knowledge and experience with both current and new technologies in chemical synthesis, biologics, and new modalities.
+ Strong Experience and track record in technical transfer activities in commercial and clinical space to favor agility and fast time to market in a high VUCA environment (volatile, uncertain, ambiguous).
+ Track record of translating innovative ways into problem solutions and the timely project advancement.
+ Applied critical thinking and vision for the future with a strong record of analyzing and interpreting sophisticated situations to provide clear direction.
+ Effective communicator with experience in teamworks and interactions, building positive relationships with customers, including connections to academic and industry networks.
**About Thermo Fisher Scientific**
Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are advancing life sciences research, solving complex analytical challenges, optimizing efficiency in their laboratories, optimizing patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our distributed team of over 130,000 colleagues presents a ground-breaking blend of powerful technologies, user-friendly purchasing options, and pharmaceutical services across our top brands like Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD. For more information, please visit ( .
If you are an individual with a disability who requires reasonable accommodation to complete any part of our application process, click here ( for further assistance!
_Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status._
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
Manufacturing Scientist III (Technology Transfer)

Posted 15 days ago
Job Viewed
Job Description
Standard (Mon-Fri)
**Environmental Conditions**
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)
**Job Description**
**Role Overview**
Complete Technology Transfer activities by performing manufacturing process development for Injectables products to commercial lines. Using experimental design, establish formulation processes, product pathway and select components for successful scaleup. Support client calls, prepare necessary documentation (including but not limited to work orders, protocols, summaries, with minimum supervision), and provides scientific justification as needed and update status of project work.
**Discover Impactful Work!**
+ Technically supports day-to-day operations in the Formulation, Filling, and/or Freeze Drying areas of the Steriles plant.
+ Leads technical/scientific process/product/project activities to implement strategies and technical solutions.
+ Drives creation of processes, single use systems, and equipment designs for clinical, scale up, and/or registration batches, including technology transfer of projects from clients.
+ Makes decisions that involve direct application of technical knowledge.
**A Day in the Life.**
+ Design, implement, and evaluate studies, lead tech transfer, commercial scale-up and support process validation.
+ Represent the organization on formal technical and scientific forums.
+ Lead and/or participate in problem solving and project work for formulations, equipment and processes.
+ Write/revise work orders for new processes, FORMs, reports, memos, and protocols as required.
+ Independently manage projects, proficient in evaluating and organizing all technical aspects of the project to achieve necessary landmarks and turning points.
+ Support manufacturing operations, change controls, investigations as subject matter expert (SME), resolve accurate CAPAs.
+ Assess material changes and determine change impact.
+ Support development of proposals and timelines for projects, leading relevant client meetings.
+ Review new bid quotes, protocols, technical documents, results, and reports.
**Keys to Success**
**Education:**
+ Bachelor's of Science in Chemistry, Biochemistry, Biology, Pharmaceutical or related physical science.
**Experience:**
+ Bachelors and 3+ years confirmed experience
+ CMO or Pharmaceutical product development experience PREFERRED
**Equivalency:**
Equivalent combinations of education, training, and meaningful work experience may be considered.
**Knowledge, Skills, Abilities:**
+ Advanced knowledge of variety of aspects of a subject area and working knowledge of principles and concepts in other relevant technical subject areas.
+ Excellent knowledge of scientific methodology and development as related to the pharmaceutical industry.
+ Detailed knowledge of Good Manufacturing Practices.
+ Strong proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint). Excellent critical and logical thinking skills.
+ Effective written, interpersonal, and presentation skills, including leading technical discussions with internal and external clients.
+ Ability to work on multiple projects simultaneously.
+ Proficiency at developing knowledge and skills in pharmaceutical processes, equipment, instrumentation, and procedures.
+ Capability to keep current with scientific literature and industry trends relating to process technologies.
+ Ability to develop technical solutions.
+ Position requires ordinary ambulatory skills and physical coordination sufficient to move about office locations; ability to stand and walk; ability to lift and/or carry light objects of up to 25 lbs. for brief periods.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
Manufacturing Scientist II (Technology Transfer)

Posted 15 days ago
Job Viewed
Job Description
Standard (Mon-Fri)
**Environmental Conditions**
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)
**Job Description**
**Job overview**
Complete Technology Transfer activities by performing manufacturing process development for Injectables products to commercial lines. Using experimental design, establish formulation processes, product pathway and select components for successful scaleup. Support client calls, prepare documentation (including but not limited to work orders, protocols, summaries, with minimum supervision), and provides scientific justification and update status of project work as needed.
**Discover Impactful Work!**
+ Technically supports day-to-day operations in the Formulation, Filling, and/or Freeze Drying areas of the Steriles plant.
+ Works on technical/scientific process/product/project activities to implement strategies and technical solutions.
+ Assists in the creation of processes, single use systems, and equipment designs for clinical, scale up, and/or registration batches, including technology transfer of projects from clients.
+ Makes decisions that involve direct application of technical knowledge.
**A Day in the Life.**
+ Complete studies, tech transfer, commercial scale-up and support process validation.
+ Represent the organization on internal technical discussions.
+ Actively participate in problem solving and project results for formulations, equipment and processes.
+ Write/revise work orders for existing processes, FORMs, reports, memos, and protocols.
+ Lead projects with a moderate level of supervision, implement change control actions, review and plans technical aspects of the project to meet timeline and project goals.
+ Support manufacturing operations, change controls, investigations as subject matter expert (SME).
+ Collects data for statistical analysis. Can support interpretation and summary of data.
**Keys to Success**
**Education:**
+ Bachelor's of Science in Chemistry, Biochemistry, Biology, Pharmaceutical, Engineering or related physical science.
**Experience:**
+ Bachelors and 2+ years of related experience, or, related Master's degree.
+ Experience in a CMO or Pharmaceutical product development field PREFERRED.
**Equivalency:**
+ Equivalent combinations of education, training, and meaningful work experience may be considered.
**Knowledge, Skills, Abilities:**
+ Excellent knowledge of scientific methodology and development as related to the pharmaceutical industry.
+ Detailed knowledge of Good Manufacturing Practices.
+ Strong proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint). Excellent critical and logical thinking skills.
+ Effective written, interpersonal, and presentation skills, including running technical discussions with internal and external clients.
+ Ability to work on multiple projects simultaneously.
+ Ability to acquire knowledge and skills in pharmaceutical processes, equipment, instrumentation, and procedures.
+ Ability to keep current with scientific literature and industry trends relating to process technologies.
+ Ability to run technical solutions.
+ Position requires ordinary ambulatory skills and physical coordination sufficient to move about office locations; ability to stand and walk; ability to lift and/or carry light objects of up to 25 lbs. for brief periods.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
Staff R&D Scientist, Continuous Manufacturing (Oral Solid Dosage)

Posted 15 days ago
Job Viewed
Job Description
Standard (Mon-Fri)
**Environmental Conditions**
Office
**Job Description**
**Join Us and Make a Difference!**
At Thermo Fisher Scientific, your work will make a global impact. From protecting the environment to ensuring food safety and supporting life-saving cancer research, we address the world's toughest challenges.
**About The Role:**
We need a committed Staff R&D Scientist to lead and assist in developing, optimizing, and validating innovative manufacturing processes. The main focus will be on Oral Solid Dose (OSD) Continuous Manufacturing. You will conduct experiments, analyze data, support product validations, and ensure smooth technology transfers to meet client and regulatory requirements. Experience applying data science or statistical analysis tools (e.g., Python, MATLAB) to support process development and optimization is highly desirable. Your expertise will be essential in achieving our ambitious goals and making a significant industry impact.
**Key Responsibilities:**
+ Develop, scale up, and optimize OSD manufacturing processes, focusing on both continuous and batch operations.
+ Design and run experiments using statistical and data science tools to enhance process and product performance.
+ Serve as the technical lead in client discussions, providing scientific rationale for process decisions.
+ Lead technology transfers from R&D to commercial manufacturing with a focus on robustness and compliance.
+ Collaborate with quality, operations, validation, and analytical teams to advance development and commercialization.
+ Apply emerging technologies and industry trends to drive innovation and efficiency.
+ Maintain compliance with regulatory, safety, and quality standards throughout development activities.
**Education:**
Bachelor's degree in chemical engineering, chemistry, pharmacy, or a related field with 4+ years of experience, preferrable within oral solid dose, Master's degree with 2+ years, or Ph.D. with no experience required.
**Experience:**
+ Proven experience in manufacturing, specifically in product or process development. This includes scale-up and technology transfer for immediate and controlled-release dosage forms.
+ In-depth knowledge of GMP, process validation, and regulatory requirements.
+ Strong problem-solving, communication, and project management skills.
+ Proficiency in programming languages such as Python or MATLAB.
+ Solid understanding of statistical tools and their application in process development.
+ Advanced knowledge of continuous manufacturing is preferred.
**Why Thermo Fisher Scientific?**
+ Career Development: Opportunities for learning, growth, and leadership.
+ Benefits: Competitive pay, healthcare, retirement plans, and more.
+ Inclusive Culture: We value different perspectives and cultivate an encouraging environment.
+ Purposeful Work: Join a team that's making a tangible difference in the world.
Do you thrive in dynamic environments and love solving sophisticated challenges? If so, we want to hear from you.
**Reasonable Accommodations**
We are committed to providing reasonable accommodations to individuals with disabilities. If you require assistance during the application process, please contact our HR team.
Thermo Fisher Scientific is an Equal Opportunity Employer. We value diversity and do not discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other legally protected status.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
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Supervisor, Formulation Manufacturing (12 hr Night Shift 2/2/3)

Posted 7 days ago
Job Viewed
Job Description
Flex 12 hr shift/nights
**Environmental Conditions**
Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc. allowed, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)
**Job Description**
When you are part of the team at Thermo Fisher Scientific, you'll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have a real-world impact, and you'll be supported in achieving your career goals.
Location/Division Specific Information
**How will you make an impact?**
Lead the Steriles North manufacturing team providing technical, mechanical and leadership to the operations activities in the assigned. Supervises operations employees of high-quality pharmaceutical products according to schedules, cost, and quality standards, while maintaining employee engagement, safety performance, and ensuring adherence to all regulatory control and documentation procedures.
**Role and Responsibilities:**
· Help to ensure successful start-up of new Sterile facility by being a member of the site project team.
· Ensures new processes/procedures are developed and implemented in a timely manner to coincide with daring project timelines.
· Assists with building and training the production team that will staff the new Sterile Filling lines.
· Provides leadership to assigned staff by performing the following: leading organizational change; developing and empowering staff; cultivating relationships; putting staff in a position to succeed, meeting their personal career goals while also achieving interpersonal goals; building effective teams that apply their diverse skills and perspectives to achieve common goals; driving engagement and crafting a climate where staff are motivated to do their best.
· Supervises employees in day-to-day operations by spending at least 50% of available time collaborating with employees to ensure that every product unit is of high quality and exceeds all current Good Manufacturing Practices (cGMPs).
· Ensures that production schedule is met by distributing workload in accordance with changing priorities.
· Ensures production operations are properly controlled and regulatory compliance requirements are met by ensuring batch documentation is accurate, Standard Operating Procedures (SOPs) are accurate, training is current, critical documentation templates are accurate, equipment is in good repair and current calibration, and high standards of housekeeping are maintained in all areas of responsibility.
· Evaluates/solves operation problems by reviewing the area of concern, developing potential solutions, technically evaluating, or testing the solutions, and preparing summary reports/recommendations for management.
· Assures compliance to all applicable regulations by proactively interpreting regulatory and compliance requirements, establishing, and maintaining systems.
· Prepares performance reviews for all employees and evaluates personnel performance according to performance management process. Provides feedback for continuous improvement. Holds staff accountable and employs coaching process as required. Assists in hiring staff as needed. Maintains a work environment with cultivate partnership and supports the company's continuous improvement process.
· Provides training and/or opportunities for career development of staff.
**Education:**
Bachelor's degree in Science, Engineering, Administration, or other STEM related program is required.
Experience:
Minimum four (4) years of technical and/or manufacturing experience.
One (1) to five (5) years of supervisory experience preferred.
Experience in project management and leading start-up, preferable.
Experience with life virus vaccine techniques and procedures
Equivalency: Equivalent combinations of education, training, and relevant work experience may be considered.
**Knowledge, Skills, Abilities:**
Knowledge in GMP's and FDA regulations.
Technical writing experience, preferred.
Technical and operational knowledge of start-up of aseptic environment for live virus vaccines.
Strong decision-making skills.
The ability to handle multiple ongoing activities and ability to prioritize tasks.
Outstanding attention to detail and organizational skills.
Capable of flourishing in a fast-paced environment, able to handle pressure and effectively manage multiple tasks.
Demonstrates ability to maintain a high degree of confidentiality.
Excellent social skills to establish and maintain effective working relationships with employees and the public, including tact to handle sensitive matters.
Highly effective verbal and technical written communication skills. Able to create SOP's, work instructions and manufacturing process.
Demonstrated ability to manage and lead professional staff in order to achieve goals, evaluate and resolve complex technical problems. Ability to motivate, energize, and retain key staff by direct interactions with supervisors and staff. Lead by example set the example for others to follow
At Thermo Fisher Scientific, each one of our 100,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission-enabling our customers to make the world healthier, cleaner and safer.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.