Principal Engineer – Cell Therapy Technical Steward

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.

Cell Therapy is one of the most groundbreaking new forms of cancer treatments being studied today. With therapies only in their infancy and BMS’s continued investment in our Cell Therapy capabilities, the growth potential of this science, your career, and the ability to help patients are incredible.

We are looking for a Principal Process Engineer to join the drug product team within the Cell Therapy GMS&T (Global Manufacturing Science and Technology) department. Global Manufacturing Sciences and Technology is responsible for tech transfer, support and harmonization of Cell Therapy Manufacturing Processes across the manufacturing network throughout the product life-cycle from pre-clinical through commercial manufacturing. The Sr. Principal Process Engineer will be responsible for the implementation of cell therapy manufacturing technologies, including cross-departmental collaboration to enable facility fit, development of process documentation (Batch Records, Forms, etc), e-systems deployment, inspection readiness, and training. The Sr. Principal Process Engineer will support global launch for new indications and new markets within Breyanzi product lifecycle management, including commercialization and label expansion as well as day to day operations to ensure reliable quality supply.  The role collaborates across all CMC functional areas and drug product manufacturing sites to ensure project advancement, rapid and best in class execution, and communication of challenges/opportunities.

Responsibilities include, but are not limited to, the following:

• Lead representative on behalf of GMS&T – Stewardship for CMC team, supporting regulatory submissions for new indications and new markets for Breyanzi
• Support launch-enabling activities for new indications and new markets at existing drug product manufacturing sites
• Support process and technology transfers, change management, and technical process support for cell therapy products.
• Implement and support the creation and execution of process control strategies including process risk assessments and continued process verification.
• Support production related investigations, ensuring compliance with internal standards and regulatory requirements.
• Provide necessary technical analysis to support impact assessments and investigations.
• Share operational and process leanings with the rest of the manufacturing network

Basic Qualifications:

• MSc or BSc in Chemical Engineering, Biochemical Engineering or equivalent with minimum of 8+ years of relevant experience. Familiarity with cell therapy processes and cGMPs is preferred.
• Ability to effectively work in cross functional teams, meet deadlines as an individual contributor, and prioritize responsibilities.
• Experience working in a self-driven, performance/results oriented, fast paced matrix environment.
• Experience assimilating large data sets in support of batch history sections for regulatory submissions.
• Excellent problem-solving skills, including issue resolution, root cause investigations and CAPAs.
• Ability to assess risk and develop contingency plans for process risks
• Able to manage time and elevate relevant issues to project lead and line management.
• Detail oriented with excellent verbal and written communication skills.
• Strong interpersonal and leadership skills to work with teams in different functions and organizations

Preferred Qualifications:

• Experienced leader on CMC teams supporting regulatory submissions and information requests from agencies
• Experience with cell therapy process development and / or manufacturing
• Experience with technology transfer in a manufacturing environment
• Proficiency utilizing MS Office products and working knowledge of statistical software (R, JMP, Minitab)
• 8-10 years of experience in MS&T and/or process development, with 5+ years in cell therapy
• Experience with commercial product support, i.e. post-marketing commitments, on-going validation and comparability

BMSCART

#LI-Hybrid

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

[email protected]

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

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