Principal Scientist, Cell Therapy Analytical Development

Job Description

Bristol Myers Squibb is developing clinical-stage, 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.

We are recruiting a scientific leader to join our Cell Therapy Analytical Development organization in Warren, NJ. The ideal candidate will work with a talented and experienced team to enable the rapid advancement of cellular therapy candidates from pre-clinical development through commercialization. In addition to proven leadership capabilities, the successful candidate should have experience in the development and implementation of analytical methods for cell and gene therapy products.

The incumbent will advance strategic and scientific direction for the department so to deepen product understanding. The candidate will establish analytical development, analytical method lifecycle management strategies, implement novel technologies. This leader will report into the head of Cell Therapy Analytical Development.

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

• Direct technical and laboratory activities focused on method development, qualification and analytical strategy for multiple cell therapy programs.
• Advance scientific understanding of cell therapy products by applying state-of-the-art cellular analytics research techniques and leading studies that aim to deepen product understanding.
• Serve as a technical interface between analytical development and quality control departments so to ensure efficient and rapid method transfer/qualification execution.
• Provide scientific and technical guidance and serve as SME for flow cytometry, molecular and cellular analytical capabilities.
• Support CMC and product development teams so to ensure robust data analysis, solid GMP method implementation, and broad incorporation of analytical strategy within CMC functions.
• Balance resource allocation based on project priorities. Communicate effectively to staff and key partners and stakeholders.
• Oversee the design, development, and qualification of analytical methods to assess product identity, purity, quality and potency. Collaborate with other Analytical Development (AD) departments to ensure the overall analytical strategy is complete and phase appropriate as a member of the AD leadership team.
• Coordinate, lead and participate in various aspects of method development, transfer, characterization, investigation and assay validation while collaborating with Cell Therapy Technology, QC, Process Development, Clinical and Commercial Manufacturing, and Quality Operations teams.
• Provide scientific guidance to development operations, and clinical and commercial QC teams. Maintain current awareness of GMP/GTP and other regulations, guidance documents, advisory committees, industry standards and trends that are applicable to current and future Cell Therapy Development operations and products.
• Provide key strategic compliance and analytical development input to projects and cross-functional teams, including process development, manufacturing implementation, IMPD and IND preparation, and discussions with regulators.

Skills/Knowledge Required:

• PhD in cell biology, Immunology, molecular Biology, or related discipline with 10 years R&D / analytical development experience.
• Previous industry or academic experience in CAR-T research and development is preferred.
• Established track record of success supporting early and late stage CMC and clinical product development teams. Cell therapy product characterization, method bridging, comparability, control strategy experience is a plus.
• Extensive technical experience in flow cytometry, molecular biology and/or cell-based potency methodologies
• Solid understanding of the fundamentals of ICH and other industry guidelines supporting method development, qualification, and transfer, with a proven ability to assimilate data and growing product knowledge into the broader aspects of CMC development and lifecycle management
• Familiarity with and constant attention to the evolving landscape through literature review/publication, conference attendance, industry working group leadership, etc.
• Strategic thinker with excellent problem solving and conflict resolution skills.
• Ability to foster a strong team-first environment with the ability to lead multiple projects.
• Demonstrated success in leading high performing assay development teams.