Cell Therapy MSAT Lead
- Munich, Germany
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.
Come and join BMS for this leadership role to be part of the team building a leading CAR T Platform that serves our patients with novel Celgene CAR T Therapies. At BMS, we are developing novel cellular immunotherapies based on two distinct and complementary platforms - Chimeric Antigen Receptors (CARs) and T Cell Receptors (TCRs) technologies. Our goal is to revolutionize medicine by re-engaging the body's immune system to treat cancer. Cell Therapy Global Manufacturing Science and Technology (GMSAT) plays a critical role in Technology Transfers, CMC life cycle management, establishing manufacturing standards, process engineering, process validation, technical oversight of external manufacturing partners and product/process capability to enable a robust and scalable global cell therapy manufacturing network.
This role will be located in Munich report to the Senior Director of Cell Therapy Global Manufacturing Science and Technology (GMSAT) External and Business Operations. This leadership role will be part of a global team and, also lead a team consisting of MSAT process engineers. The role will require collaboration with a variety of teams, and groups/functions across the globeas well as with our CMOS and Suppliers. The lead will recruit and manage the team, build capabilities/ learning, provide technical oversight to contract manufacturing sites and suppliers in our network for our new/innovative platform formulations, technologies developed at the Juno Therapeutics Munich site, a Bristol-Meyers Squibb company. The lead is expected to hire, develop and grow strong technical talent and provide effective technical and people leadership to the Munich MSAT team. The role will work very closely with the process engineering team at Juno Therapeutics Munich and CMOs and suppliers for the materials associated with Munich and new technologies, Drug Product MSAT, Technology groups based in Munich, New Jersey and Seattle, Technical Development, External Manufacturing Supply Chain and Quality and the product life cycle management teams.
The roles and responsibilities include:
- Provide technical oversight to the relevant CMOs and Suppliers for the Munich based new technologies and ensure commercialization readiness (compliance and robust supply), including dual or new sourcing strategies
- Ensure that the commercial manufacturing requirements are communicated to the technology teams and these requirements are incorporated in the next generation CAR T processes.
- Work with external manufacturing to identify CMOs for GMP manufacture of the reagents and critical materials needed for the next generation CAR T processes.
- Successfully transfer next generation CAR-T processes and/or technology solutions to manufacturing sites in the BMS network
- Review/author technical sections of major regulatory documents to introduce next generation CAR T processes into clinic and commercial
- Work with the CAR T drug product MSAT and technical product steward teams to ensure that the next generation CAR T technologies are incorporated in the product life cycle plans
- Support, lead process qualification, process control and comparability strategies for the next generation CAR T processes
- Implement proactive process monitoring to ensure robust supply of these critical materials.
- Collaborate with product teams to develop commercial process control strategy for the CAR T reagents and critical material processes and implement these strategies at the manufacturing sites (including CMOs)
- Provide technical leadership/support to regulatory/health authority questions for the manufacturing operation (either part of the initial licensure or post approval changes or routine inspections)
- Review, approve validation plans, protocols as appropriate
- Review, approve sections of the regulatory dossier, briefing books or communications to health authorities
- Work with process and analytical development to demonstrate comparability upon process changes
- Travel as required to Seattle, and NJ sites for critical meetings as well as to CMOs, Suppliers for troubleshooting, critical batches, etc. ~25%
- Bachelor's degree in a life sciences or Chemical Engineering discipline and a minimum of 10 years of relevant experience in biologics, vaccines or cell/gene therapy development, MSAT or operations.
- Min 8 years of direct experience in GMP environment, and min 4 years of people management,
- Min 5 years of experience in cell culture and/or downstream purification/chromatography
Knowledge in fermentation, lyophilization, raw material qualification and vendor management in supply chain
- Previous experience working in a global environment where interactions spread across multiple sites, locations, functions
- Experience in product/process CMC life cycle management including pre-launch, launch and post- approval
- Strong analytical, problem-solving, and critical thinking skills
- Excellent written and verbal communication skills at all levels in the organization
- Experience working with suppliers and contract manufacturing sites
- 2-3 years of experience in cell therapy process development and or manufacturing.
- Combination of experience in process development, MSAT and quality.
- Lean and Six Sigma experience
- Language skills English and German
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.
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