Principal Engineer, CAR T Technology Commercialization
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.
We are looking for a Senior Engineer/Principal Engineer to lead Technology projects in the Technology Commercialization group within the Process Engineering team in Global Manufacturing Sciences and Technology.
The successful candidate will lead technology-driven lifecycle management changes and implement GMP utilization of automated process and analytical technologies throughout CTDO network. Enable faster realization of the projects driving product differentiation via coordination with site teams and the creation of repeatable approaches. Scope of this role is to focus on GMP implementation of custom automated processing equipment (including DeltaV distributed control system), interfaces with configured benchtop bioprocessing equipment (e.g. bioreactor, cell washer) and laboratory automation (liquid handler) efforts.
Global automation interfaces with the early stage teams/committees to represent GMP site implementation interests in planning, development, and prototyping stages, and then coordinate with project teams throughout execution phases to communicate global strategy and share information. Standardize approaches and minimize redundant efforts to efficiently roll out technology to multiple sites.
- Manage implementation of new technology projects and transfers into clinical and commercial manufacturing
- Implement process improvement projects to improve robustness, scalability and COGs for cell therapy products
- Lead ATC and other technology projects through implementation in JuMP, S12, Devens and other new CTDO sites
- Partner with teams responsible for automation project deliverables to align strategy and identify global best practices for network
- Expand automation lifecycle to enable phase appropriate implementation, realizing benefits of technologies in both early stage and commercially approved products
- Participate in new technology committees to represent global MSAT goals
- Interface with vendors of custom and configurable equipment to plan for GMP requirements of future technologies
- Ensure Technical requirements are addressed throughout lifecycle of new solutions while ensuring focus on quality and manufacturing requirements
- Author technical reports to support product lifecycle and support regulatory submissions.
- Partner with system integration teams, business process owners and other global teams to align process data handling initiatives within the automation projects
- Collaborate with Regulatory, CMC, and other stakeholders to enable new technologies at commercial manufacturing sites within existing regulatory and operational constraints
Specific Knowledge, Skills, Abilities, etc:
- The candidate must have demonstrated verbal, written, and communication skills including ability to present complex information clearly and concisely, with a successful proven history of working with technical teams.
- Experience should include technical support of a cGMP manufacturing facility, including strong knowledge and engineering leadership for cell therapy manufacturing and processing equipment, manufacturing support and technology transfer.
- Proven track record of managing Tech Support, development and/or validation projects
- Demonstrated leadership skills, and the ability to interact with and lead diverse groups and teams are essential.
- Proven project management skills (organization, collaboration, multi-tasking, and communication), attention to detail, and the ability to perform well in a team-based environment are required
- Prior experience in/knowledge of cell therapy preferred
- Prior experience with SOPs, cGMPs and the know how to work within a regulatory environment required
- Prior experience facilitating/participating in Risk Assessments preferred
- D05 Senior Engineer: Degree in Biochemical or Chemical Engineering or Sciences: Minimum of a Bachelor's degree with 10+ years of experience, Master's degree with 8+ years or Ph.D. degree with 6+ of experience
- D06 Principal Engineer: Degree in Biochemical or Chemical Engineering or Sciences: Minimum of a Bachelor's degree with 12+ years of experience, Master's degree with 10+ years or Ph.D. degree with 8+ of experience
- Familiarity with cell therapy processes is preferred.
- Ability to effectively lead cross functional teams, meet deadlines, and prioritize responsibilities.
- Experience working in a self-driven, performance/results oriented, fast paced matrix environment.
- Excellent problem-solving skills, including issue resolution
- Ability to assess risk and develop contingency plans for process risks
- Able to manage time and elevate relevant issues to management and governance forums.
- Detail oriented with excellent verbal and written communication skills.
- Strong interpersonal and leadership skills to work with teams in different functions and organizations
- Position requires repetitive use of hands and wrist (computer work)
- Occasional bending, twisting and stooping to allow for gowning into classified environment required
- Position is primarily office based with frequent visits to technology implementation sites
- This position may require up to 20% of travel
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.