Director, 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 Director level candidate to join our Process Engineering team in Global Manufacturing Sciences and Technology (GMS&T).
The successful candidate will lead new technology projects to drive lifecycle management changes and implement GMP utilization of automated process and analytical technologies throughout CTDO network. The leader will enable faster realization of the projects driving product differentiation, turn-around time and COGS reduction goals via coordination with site teams and the creation of repeatable approaches. Scope of this role will be to focus on GMP implementation of custom automated processing equipment (including DeltaV distributed control system). This position interfaces with the early stage teams/committees to develop an early line of sight and CMC strategy for commercialization of technology projects in the cell therapy manufacturing network balancing considerations of multiple products and sites. The leader will interface with early stage technology development teams to represent GMP and manufacturing implementation perspectives in planning, development, and prototyping stages, and then coordinate with validation and 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. Leader will oversee team of technical leaders responsible for implementation of portfolio of technology projects. A key aspect will be to ensure alignment with the life cycle management plans of the individual product teams. Leader will work cross functionally to develop business case for technology projects to drive aligned prioritization across the organization to focus implementation on the most impact full projects.
- 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 AMPs, 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
- Participate in new technology committees to represent manufacturing requirements and transfer learning from commercial manufacturing experience into future technology projects
- 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
- 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
- Develop CMC strategies to ensure approvability of new technology related post approval regulatory changes
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 strong knowledge and engineering leadership for facility and processing equipment and proven track record of managing technology 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 culture, viral vector manufacturing, recovery and/or purification of viral vector product in a manufacturing environment required
- Prior experience with SOPs, cGMPs and the know how to work within a regulatory environment required
- Prior experience facilitating/participating in Risk Assessments preferred
- Degree in Biochemical or Chemical Engineering: Minimum of a Master's degree with 14+ years or Ph.D. degree with 12+ of experience
- Experience with facility and equipment qualification is preferred.
- 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 occasional work in a classified GMP manufacturing environment
- Position is a team & project-based position that will require occasional shift work, weekends, and holidays
- This position may require up to 25% of travel within the cell therapy manufacturing network
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.