200 Catalent Pharma Solutions jobs in the United States

Day to day: A large pharmaceutical client is seeking a team of Cleaning Equipment Validation Engineers to support their site build out in Raleigh0Durahm. The ideal candidate will have hands on validation experience, documentation experience and experience working within regulated pharmaceutical environment. The first 3-4 months will be heavily focused on documentation and protocols. Once engineering runs begin in the fall, the role will move into the field supporting cleaning validation activities on the floor. Samples will be taken, protocols filled, and swaps taking place. Mid next year the site will move into 24/7 operations.



Responsibilities:

Conduct PQs for parts washers and other cleaning equipment

Define cleaning parameters & take samples

Assist with CIP procedures and systems

Communicate with vendors and teams onsite

Develop and execute cleaning validation protocols and reports for new equipment and facilities.

Perform risk assessments to identify potential contamination sources and establish appropriate cleaning procedures.

Collaborate with cross-functional teams, including Quality Assurance, Manufacturing, and Engineering, to ensure cleaning validation activities are integrated into the overall project plan.

Conduct cleaning validation studies, including sampling, testing, and data analysis.

Investigate and resolve deviations and discrepancies related to cleaning validation.

Maintain accurate and detailed documentation of all cleaning validation activities.



Must Haves:

~4+ years of experience with cleaning validation

~ Bachelors Degree in Engineering or related field

~ Experience with cGMP documentation and validation life cycle

~ Experience writing cleaning validation reports, risk assessments, protocols and investigating and resolving deviations

~ Experience with Kneat – high preference for this

~ Experience with greenfield, brownfield or new facility build outs desirable





Pluses:

~ Cleaning validation experience with both small parts & large scale equipment like bioreactors

**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 .
**Position Summary:**
The Senior Corporate Counsel, DD Law role will have the opportunity to join the dynamic DD Law team at BMS. The DD Law team provides critical support and partnership to the global Drug Development organization, helping to deliver on our mission to develop and deliver more medicines to more patients faster. This individual will join an expert team of global Drug Development lawyers and will be charged with serving as a substantive leader for complex escalations and advising on novel approaches to accelerate development.
This individual should bring pharmaceutical legal experience with the ability to learn quickly, exercise excellent judgement, navigate complexity and be able to work with urgency and creativity across time zones, regulatory regimes, and senior stakeholders to advise on the successful resolution of legal and business issues and enable speed of getting medicines to patients who cannot wait. Excellent legal judgement and the ability to clearly communicate on complex topics with senior business stakeholders is critical to success in this role.
**Responsibilities:**
+ Serve as the lead legal advisor to Senior Vice Presidents reporting into the Executive Vice President, Head of Drug Development, and join their senior leadership teams, advising on complex issues that arise during the course of global drug development. Potential business clients to be supported include, SVP, Head of Global Development Operations, SVP Head of Global Regulatory Sciences, and SVP Head of Worldwide Patient Safety.
+ Collaborate with Drug Development legal team to develop and advance innovative approaches to accelerate drug development transactions, including automation.
+ Advise senior leaders on Drug Development initiatives that evolve internal and external stakeholder ways of working and improve the speed, accuracy and quality of drug development and ultimately speed of life-saving medacines to patients.
+ Work closely with Law Department colleagues to bring seamless legal support to Drug Development and provide DD legal guidance across the Law Department.
**Qualifications:**
+ Legal degree with 12 or more years of pharmaceutical legal experience. Helpful experience includes law firm, in-house and/ or government work experience. Experience working in the R&D space is helpful, but not required.
+ Demonstrated ability to develop strong relationships with colleagues and advise and influence senior executives, including SVP or C-suite stakeholders, on high-impact legal and regulatory matters.
+ Proven history of identifying and leading senior stakeholders and colleagues to implement innovative solutions to reduce waste, increase efficiency and improve management of legal risks.
+ Demonstrated ability to lead across large, global matrix organizations and influence senior leaders and colleagues across multiple functions to efficiently resolve complex issues.
+ Ability to independently prioritize and manage multiple projects.
+ Flexibility to work with speed and quality on a broad range of matters.
+ Ability to communicate complex issues clearly and concisely, verbally and in writing to senior leaders.
+ Excellent judgement, time management, and cross functional collaboration skills required.
+ Licensed to practice in the U.S.
#LIHybrid
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.
**Compensation Overview:**
Princeton - NJ - US: $255,260 - $309,309
The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee's work schedule, job-related knowledge, and experience. 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 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.
**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:** R
**Updated:** :05:56.553 UTC
**Location:** Princeton-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.

_This position is on-site in Tarrytown, NY 4 days a week and 1 day from home. A fully remote role is not possible for this position._
Using extensive program management knowledge and experience in the drug development industry, the **Director, Development Program Management** provides operational leadership, direction and support to a team, program or project of moderate to large scope, (within a given Therapeutic Area) as well as to the DPM department as a whole. The Director, Development Program Management executes the strategic direction of a program from preclinical through commercialization by driving the development and implementation of integrated (project) program plans, goals, budgets, and timelines. Director, Development Program Management is responsible for the successful operation of activities of major significance to the organization.
**In a typical day you will:**
+ Provide operational leadership, direction and support of a program throughout its lifecycle, by integrating key stakeholders from Discovery, Manufacturing, Preclinical, Global Development and Commercial.
+ Independently lead multiple or complex development programs.
+ Partner with the Strategic Program Lead to provide operational leadership of program(s) and supports development and execution of overall program strategy by facilitating cross-functional Strategic Development Team. Independently assesses and proactively addresses the needs of the program from pre-IND through commercialization and makes operational decisions to support requirements for success. Strengthens and leads high performance teams.
+ Leverage significant project management experience and knowledge of the drug development process, drives team alignment in creation of integrated project / program plans, timelines and budgets. Ensures efficient delivery of plans. Directs annual program goal setting in alignment with Regeneron's overall goals and monitors progress against these goals. Champions potential program risks and ensures contingency plans are in place.
+ Act as a key liaison between Regeneron and our strategic alliance partners and collaborators (where applicable). Prepares, provides input, and / or manages the process involving major presentations for collaboration meetings effecting key business decisions. Responsible for facilitating and driving decision making in support of the joint strategic objectives of the program.
+ **Communication:** Ensures effective, accurate, and timely scientific / technical program-related communication to the team and Sr. Management. Adept at tailoring communications based on audience, effectively framing and communicating nuanced context for stakeholders and capturing rationale for decisions.
**This role may be for you if you:**
+ Have excellent written, verbal and interpersonal communication skills and the ability to effectively interact with all levels both within and outside the company in order to establish credibility with professionals on the project teams.
+ Understand and motivate others and build effective teams.
+ Have strong presentation and critical thinking skills.
+ Actively promote constructive interactions among team members in order to address difficult situations.
+ Resolve and negotiate conflicts or problems with tact, diplomacy and composure.
+ Handle multiple projects and priorities with exceptional organizational and time management skills (both project and self)
+ Thrive in fast paced organizations; expert in dealing with ambiguity and uncertainty
**In order to be considered qualified** , you must have a Bachelor's degree and 12+ years of in-house pharmaceutical program management with knowledge of the drug development process as well as understanding of clinical trials.
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels!
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.
For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.
Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.
**Salary Range (annually)**
$180,400.00 - $300,700.00

This position is on-site 4 days per week and 1 day from home. A remote position is not possible for this role.
**The Manager Development Program Management** provides operational direction as the leader for one or more development programs. Manager Development Program Management executes the strategic direction of a program from preclinical through commercialization by driving the development and implementation of integrated program plans, goals, budgets, and timelines. The Manager Development Program Management is responsible for forming and managing effective cross functional teams and leads a network of functional area project managers.
**In a typical day you will:**
+ Support development of a program throughout its lifecycle, by integrating key stakeholders from Discovery, Manufacturing, Preclinical, Global Development and Commercial. Independently manages multiple development programs, often working under consultative direction.
+ Partner with the Strategic Program Lead to provide operational leadership of program (s) and supports development and execution of overall program strategy by facilitating cross functional Strategic Development Team. Assesses and proactively addresses the needs of the program from pre-IND through commercialization and makes operational decisions to support requirements for success. Actively aims to strengthen and lead high performance teams.
+ Lead annual goal setting sessions to develop project / program level goals that align with Regeneron's overall goals and monitors progress against these goals.
+ Develop contingency and risk mitigation plans. Oversees the development of integrated project / program plans and actively monitors progress against the approved baselines. Responsible for oversight of the integrated program timeline and budget, including management of variances and escalation where appropriate.
+ Manage the project / program interactions and deliverables between Regeneron and our strategic alliance partners and collaborators (where applicable). Fosters collaborative relationships across the alliance program teams to develop and execute strategic development plans.
**This role may be for you if you:**
+ Have excellent written, verbal and interpersonal communication skills
+ Can motivate others and build effective teams.
+ Possess strong critical thinking skills.
+ Can make connections and relate details to broader program strategy and goals.
+ Resolve and negotiate conflicts or problems with tact, diplomacy and composure.
+ Are highly organized, and have solid time management skills (both project and self), with ability to manage multiple priorities.
**In order to be considered for this opportunity** , you must have a BS or MS degree with at least 7+ years of relevant broad project/program management experience required, preferably in the pharmaceutical or related industry and drug development. Specific experience managing the development strategy for a drug candidate is necessary.
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels!
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.
For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.
Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.
**Salary Range (annually)**
$113,100.00 - $184,700.00

Our client, a leading pharmaceutical innovator, is seeking a highly skilled and experienced Senior Formulation Scientist to join their dynamic Drug Development team in Austin, Texas, US . This role is crucial in advancing our pipeline from pre-clinical to clinical stages, focusing on developing robust and scalable drug delivery systems. The ideal candidate will possess a deep understanding of pharmaceutics, solid dosage forms, and advanced drug delivery technologies. You will be responsible for designing, executing, and interpreting formulation development studies, troubleshooting technical challenges, and contributing to regulatory filings. This will involve extensive hands-on laboratory work, including pre-formulation characterization, excipient screening, prototype formulation development, process optimization, and stability testing. You will collaborate closely with cross-functional teams, including analytical chemistry, process development, and clinical operations, to ensure seamless project progression. Key responsibilities include developing formulations for oral solid dosage forms (tablets, capsules), evaluating drug solubility and stability, selecting appropriate excipients and manufacturing processes, and scaling up formulations from lab bench to pilot scale. A strong commitment to Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP) is essential. The successful candidate will also mentor junior scientists, contribute to intellectual property generation, and stay abreast of the latest scientific advancements in pharmaceutical formulation. A Ph.D. or Master's degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or a related field, coupled with at least 5 years of relevant industry experience, is required. Excellent analytical, problem-solving, and communication skills are paramount for success in this challenging and rewarding position.

Our client, a leading pharmaceutical company dedicated to improving global health, is seeking an accomplished Senior Formulation Scientist to join their innovative research and development team. This is a vital, in-office position located in the heart of the thriving pharmaceutical hub of Durham, North Carolina, US . The Senior Formulation Scientist will be instrumental in the design, development, and optimization of novel drug delivery systems and dosage forms. You will leverage your extensive scientific expertise to guide projects from early-stage feasibility through to late-stage clinical development, ensuring the successful translation of promising drug candidates into safe and effective therapies.

Key Responsibilities:

• Lead the formulation development of various dosage forms, including oral solid, liquid, semi-solid, and injectable products.
• Design and execute experiments to investigate drug solubility, stability, bioavailability, and release profiles.
• Utilize DoE (Design of Experiments) principles to optimize formulations and manufacturing processes.
• Characterize drug products using a range of analytical techniques (e.g., HPLC, dissolution testing, DSC, XRD).
• Develop and validate analytical methods for formulation testing and release testing.
• Prepare comprehensive technical reports, development summaries, and regulatory submission documents.
• Collaborate with cross-functional teams, including pre-clinical, clinical, analytical development, and manufacturing departments.
• Troubleshoot formulation and process-related issues, proposing and implementing effective solutions.
• Evaluate new excipients, technologies, and manufacturing processes relevant to drug formulation.
• Mentor junior scientists and contribute to the growth and development of the formulation sciences team.
• Stay current with regulatory guidelines (FDA, EMA) and industry best practices in pharmaceutical development.

The ideal candidate will possess a Master's or Ph.D. in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or a related discipline, with a minimum of 5-7 years of experience in pharmaceutical formulation development. A deep understanding of physical pharmacy, drug delivery principles, and GMP (Good Manufacturing Practice) is essential. Proven experience with solid-state characterization and advanced analytical techniques is highly desirable. Excellent written and verbal communication skills, strong project management abilities, and a collaborative mindset are crucial for success in this role. This is a challenging and rewarding opportunity to contribute to the advancement of innovative medicines.

A pioneering pharmaceutical company focused on developing novel therapeutics is seeking an exceptional Lead Formulation Scientist to join their cutting-edge, fully remote research and development team. This critical role will drive the formulation development of new drug candidates, from preclinical stages through to clinical trials. You will be responsible for designing, optimizing, and characterizing various drug delivery systems, ensuring bioavailability, stability, and efficacy. The ideal candidate will possess extensive expertise in pharmaceutical sciences, with a strong background in pre-formulation studies, solid dosage forms, sterile injectables, or other relevant areas. Your responsibilities will include conducting extensive literature reviews, developing experimental plans, executing laboratory experiments, and analyzing data to select optimal formulations. You will collaborate closely with discovery scientists, analytical chemists, and project managers to advance drug candidates through the pipeline. This position requires a deep understanding of regulatory requirements (e.g., FDA, EMA) and the ability to translate scientific findings into robust formulation strategies. You will also be involved in troubleshooting formulation challenges and contributing to the intellectual property strategy of the company. This is a unique opportunity for a highly skilled and motivated scientist to lead impactful formulation projects in a dynamic, remote-first environment, contributing to the development of life-changing medicines.Responsibilities:

• Lead and execute formulation development strategies for new drug candidates.
• Design and optimize drug delivery systems (e.g., oral solids, injectables, topical).
• Conduct pre-formulation studies to assess drug properties and compatibility.
• Develop and validate analytical methods for formulation characterization.
• Perform stability studies and interpret results to ensure product integrity.
• Troubleshoot formulation challenges and propose innovative solutions.
• Collaborate with cross-functional teams, including analytical development, pharmacology, and CMC.
• Prepare technical reports, development summaries, and regulatory submission documents.
• Stay abreast of scientific advancements and regulatory guidelines in pharmaceutical formulation.
• Contribute to the intellectual property portfolio through patent filings.

Qualifications:

• Ph.D. in Pharmaceutical Sciences, Pharmaceutics, Chemistry, or a related field.
• Minimum of 8 years of experience in pharmaceutical formulation development.
• Proven expertise in drug delivery technologies and formulation design.
• Strong understanding of pre-formulation, analytical techniques, and stability testing.
• Experience with regulatory requirements for drug development (IND, NDA).
• Excellent data analysis, problem-solving, and critical thinking skills.
• Strong written and verbal communication skills.
• Ability to work independently and lead research projects in a remote setting.
• Experience with LIMS and electronic lab notebooks is a plus.

Our client, a pioneering pharmaceutical company dedicated to developing innovative therapies for challenging diseases, is actively seeking a world-class Principal Scientist, Oncology Drug Development. This is a fully remote opportunity, allowing you to contribute your expertise from any location in the US. You will lead critical aspects of early-stage oncology drug development, from target validation through to IND submission. Your work will directly impact the lives of patients by advancing novel cancer treatments from the laboratory bench to clinical trials. Responsibilities will encompass:

• Leading the design and execution of preclinical research programs to characterize novel oncology drug candidates, including MoA studies, PK/PD modeling, and efficacy assessments in relevant preclinical models.
• Developing and validating complex in vitro and in vivo assays to support drug discovery and development efforts.
• Providing scientific leadership and strategic direction for oncology pipeline projects.
• Collaborating extensively with cross-functional teams, including medicinal chemistry, DMPK, toxicology, translational medicine, and clinical development.
• Interpreting complex experimental data, generating high-quality reports, and preparing regulatory submission documents (e.g., INDs).
• Mentoring and guiding junior scientists and research associates within the oncology group.
• Representing the company at scientific conferences and contributing to publications in high-impact journals.
• Evaluating new technologies and approaches to enhance oncology drug discovery and development capabilities.
• Ensuring rigorous adherence to scientific rigor, ethical standards, and all applicable regulatory guidelines.

Qualifications:

• Ph.D. in Cancer Biology, Pharmacology, Molecular Biology, or a closely related field.
• A minimum of 8 years of relevant industry experience in oncology drug discovery and development, with a strong publication record.
• Deep understanding of cancer biology and diverse therapeutic modalities (e.g., small molecules, biologics, antibody-drug conjugates).
• Proven expertise in developing and utilizing various preclinical oncology models (cell lines, patient-derived xenografts, genetically engineered mouse models).
• Hands-on experience with quantitative bioanalysis (e.g., LC-MS/MS, ELISA) and PK/PD analysis is highly desirable.
• Exceptional critical thinking, problem-solving, and strategic planning abilities.
• Excellent leadership, communication, and interpersonal skills, with the ability to foster collaboration in a remote environment.
• Experience in preparing regulatory documents (e.g., Investigator's Brochures, IND sections) is a significant advantage.
• A passion for advancing cancer patient care through innovative science.

This remote role is an exceptional opportunity for a seasoned oncology drug development expert to make a profound impact on patient lives and drive the success of a forward-thinking pharmaceutical organization.