Senior Manager, Principal Engineer or Scientist

At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis. Our cell therapy platforms focus around two distinct and complementary technologies Chimeric Antigen Receptors (CARs) and T-Cell Receptors (TCRs). Our goal is to revolutionize medicine by re-engaging the bodys immune system to treat cancer.

Come, join the BMS Cell Therapy Development and Operations (CTDO) Division, and be a part of the team building leading cell therapy platforms to serve our patients with novel cellular immunotherapies. The Global Manufacturing Science and Technology (GMS&T) Division of CDTO plays a critical role in technology transfers, process validation, CMC life cycle management, technical oversight of external and internal manufacturing partners, process engineering and establishing manufacturing standards to enable a robust and scalable global cell therapy manufacturing network.

We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

POSITION SUMMARY:

We are looking for a Principal Engineer to join our Devens Manufacturing Science & Technology team in GMS&T.

The successful candidate will support process and analytical clinical and/or commercial transfers, support and implement lifecycle changes, and support the training and start-up of new facilities. He/she will collaborate with SMEs, user groups, quality groups, and other stakeholders to accomplish transfer and start-up goals including: support facility design, provide user specification, process simulations, transfer lot generation, comparability studies, test plan generation, operator training, and troubleshooting. He/she will also participate in strategic discussions, anticipate bottlenecks and transfer risks, and address risks/issues proactively, while fostering an environment of teamwork.

Duties/Responsibilities:

• Interface with manufacturing site operations teams and process/analytical SMEs to learn and implement processes, procedures, and methods
• Support facility start-up efforts through specification, review, and testing of equipment and electronic systems
• Support buildout of GMS&T laboratory through equipment procurement, installation, startup, and lab organization
• Design and execute test plans, front runs, and other risk mitigation and validation exercises
• Coordinate project planning, timeline, communications, and risk management activities
• Support manufacturing, QC and QA throughout transfer by providing training, answering questions, clarifying intent of procedures, solving problems, and contributing to operational strategies
• Anticipate and address issues in manufacturing related to process, documentation, or training
• Provide technical input and investigation support for deviations/OOS
• Assist in the management of changes, and in the implementation of process improvements
• Provide process-related input to clinical or commercial supply facilities
• Provide technical input in support of regulatory submissions
• Interact with other CMC teams including Operations, QA, Development, and Regulatory
• Foster strong inter-team relationships to achieve common project goals

QUALIFICATIONS

Specific Knowledge, Skills, Abilities, etc:

• Strong experience with SOPs, change controls, cGMPs and the know how to support and work within a regulatory environment
• Established track record of success with sound technical qualifications and knowledge in process development, characterization, and troubleshooting
• Flexibility to work within manufacturing schedules as required
• Familiarity with literature on process development and cell therapy
• Ability to assess risk and develop contingency plans for process risks
• Excellent problem-solving skills, including issue resolution
• Detail oriented with excellent verbal and written communication skills
• Strong interpersonal and leadership skills to work with teams across sites and in different functions and organizations

Education/Experience/ Licenses/Certifications:

• B.S. with 8-10 years, M.S. with 6-8 years , or Ph.D. with 4+ years , or Ph.D. with relevant experience in Biochemical, Chemical, or Biomedical Engineering or Cell Biology/Immunology discipline
• Experience with cellular therapies is strongly preferred
• Experience in supporting a regulated manufacturing environment
• Experience working in a self-driven, performance/results oriented, fast paced matrix environment.

Physical Demands:

• Position requires repetitive use of hands and wrist (computer work)
• Frequent standing, walking, grasping, pushing and pulling in a laboratory environment
• Occasional bending, twisting and stooping to allow for gowning into classified environment required

Work Environment:

• Position is a fairly even split between good laboratory practice (GLP) biosafety level 2 (BSL2) lab and office with occasional work in a classified GMP manufacturing environment
• Position is a team & project-based position that will require occasional weekends and shift work as required.

Travel:

• This position may require up to 25% of travel

BMSCART

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

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.

Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.

To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.

Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

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