Senior Process Engineer I, CTTO Drug Product

About the position

Bristol Myers Squibb is reimagining the future of cell therapy, with a bold ambition and a commitment to unlock the full promise of cell therapy. The BMS Cell Therapy Development Organization (CTDO) is developing novel cellular immunotherapies based on Chimeric Antigen Receptors (CARs) and T Cell Receptors (TCRs) technologies. The company is looking for a Manager / Senior Engineer to join the Breyanzi Product Stewardship Cell Therapy Technical Operation (CTTO) department, responsible for implementing cell therapy manufacturing technologies and process changes related to the life-cycle management of a commercial CAR-T Therapy. This role involves establishing strategies for process changes, coordinating technical alignment, and leading implementation at a global level, collaborating across all CMC functional areas and drug product manufacturing sites.

Responsibilities

• Develop and implement process improvement projects to improve robustness, scalability, and Cost of Goods (COGs) for cell therapy products.
• Develop product technical strategies including manufacturing requirements, process improvement plans, and ensure successful and timely execution working across functional groups.
• Maintain oversight of process capability through data trending and statistical analysis of critical variables, ensure processes are robust, in a continued state of validation, and continuously improving.
• Provide technical content for significant documents such as validation activities, author content for regulatory submissions.
• Ensure technical and manufacturing requirements are addressed throughout lifecycle of new solutions.
• Provide necessary technical analysis to support impact assessments and investigations.
• Function as a subject matter expert for autologous T-cell therapies and manufacturing technologies.
• Provide technical input and requirements for design of future clinical and commercial manufacturing facilities.
• Present complex technical topics internally and externally.
• Share operational and process leanings with the rest of the manufacturing network.

Requirements

• B.S. with 6+ years or M.S. with 5+ years of relevant experience in Biochemical, Chemical, or Biomedical Engineering or Cell Biology/Immunology discipline.
• 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.
• Strong interpersonal and leadership skills to work with teams in different functions and organizations.
• Excellent verbal & written communications skills. Interpersonal and facilitation skills necessary to lead people and multi-disciplinary teams.
• Detail oriented with excellent verbal and written communication skills.
• Strong leadership skills and ability to influence and work across organizational boundaries.
• Experience assimilating large data sets in support of batch history sections for regulatory submissions.
• Proficiency in data management/statistical analysis software, including Excel, JMP, and Spotfire is preferred.
• Experience with Lean Six Sigma projects, cellular therapies, process validation, in-depth manufacturing systems is strongly preferred.
• Experience with regulatory agency inspections and regulatory responses is a plus.
• 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.

Nice-to-haves

• Drive strong collaboration within the group and across functions.
• Build trust and effective relationships with peers and stakeholders.
• Create an environment of teamwork, open communication, and sense of urgency.
• Demonstrate ability to drive for results and lead innovation and change.
• Foster a culture focused on science and compliance and strong environmental, health, and safety performance.
• Have a mindset of continuous improvement, problem solving, and prevention.
• Effective verbal and writer communication skills with technical writing skills.
• Must have ability to work as self-starter and handle multiple priorities in a dynamic cross-functional team-based environment.

Benefits

• 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 including 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.
• Tuition reimbursement and a recognition program.