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Associate Director – Automation Process Development
| Company | Bristol Myers Squibb |
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| Location | Seattle, WA, USA |
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| Salary | $156000 – $195000 |
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| Type | Full-Time |
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| Degrees | Master’s, PhD |
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| Experience Level | Senior, Expert or higher |
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Requirements
- Ph.D. in Cell Biology, Bioengineering, Immunology, or related discipline with 8+ years of relevant industry experience; or M.S. with 12+ years.
- Proven experience in both early and late-stage process development for cell therapy (e.g., autologous or allogeneic T cells, NK cells, iPSCs, etc.).
- Demonstrated success in technology development and integration, including automation, closed systems, or novel manufacturing platforms.
- Demonstrated experience in technology transfer, including authorship of tech transfer packages and cross-site coordination.
- Deep understanding of cGMP requirements and regulatory expectations for cell therapy products.
- Excellent project management, leadership, and communication skills.
- Ability to thrive in a fast-paced, dynamic environment and lead cross-functional teams.
Responsibilities
- Lead and manage end-to-end process development efforts for cell therapy programs across early and late-stage development.
- Design and execute experiments to optimize unit operations including cell isolation, activation, gene modification, expansion, harvest, formulation, and cryopreservation.
- Drive technology development and integration efforts to improve process robustness, scalability, automation, and cost-effectiveness.
- Collaborate closely with analytical development, manufacturing sciences, and quality functions to ensure seamless technology transfer and clinical/commercial readiness.
- Guide and oversee technology transfer activities, including drafting of technical packages, process risk assessments, and support for clinical and commercial manufacturing.
- Author and review technical reports, development summaries, regulatory filings (e.g., IND, BLA), and responses to agency questions.
- Lead, mentor and develop a team of scientists and engineers.
- Evaluate and implement emerging technologies and tools relevant to cell therapy development.
- Support external collaborations and relationships with a cross functional team.
Preferred Qualifications
- Experience with gene-modified cell therapies (e.g., CAR-T, TCR-T).
- Familiarity with process modeling, DoE, and statistical analysis tools (e.g., JMP).
- Hands-on experience with single-use systems, bioreactors, and automated platforms.
