Associate Director, Process Development, Cell Therapy
About The Position
The Associate Director, Late-Stage Cell Therapy Process Development, provides scientific and technical leadership for developing, characterizing, and transferring manufacturing processes for cell therapy products. The role leads a team of scientists and engineers supporting process development from clinical development through commercialization, including BLA and global regulatory submissions. It partners with Manufacturing, Quality, Regulatory Affairs, Analytical Development, and CMC teams to ensure robust, compliant, and scalable manufacturing processes. The position also leads lifecycle management for commercial cell therapy products and provides scientific support to manufacturing operations, including deviation investigations, root cause analyses, impact assessments, and CAPA development. It supports PPQ, technology transfer, regulatory documentation, and ongoing process improvement and commercial readiness.
Requirements
- Ph.D. in Chemical Engineering, Biochemical Engineering, Biological Sciences, Biotechnology, Pharmaceutical Sciences, or a related discipline with 6+ years of industry experience; or M.S. with 10+ years of relevant experience; or B.S. with 12+ years of relevant experience.
- Strong technical expertise in cell therapy process development, GMP operations, and late-stage/commercial readiness.
- Experience with late-stage development and PPQ for cell therapy processes.
- Proficiency in applying AI tools and digital solutions to data analysis, documentation, and workflow automation.
- Strong technical writing, data analysis, and problem-solving skills.
- Strong team management and talent development experience.
- Excellent cross-functional communication and collaboration skills.
- Ability to work effectively in fast-paced, late-stage development environments.
- Scientific curiosity, an ownership mindset, and willingness to support manufacturing operations.
Nice To Haves
- Experience with commercial-stage cell therapy or biologics products.
- Experience supporting PPQ, process validation, and post-approval changes.
- Familiarity with global regulatory requirements and lifecycle management strategies.
- Experience designing and executing DOE and multivariate data analysis for cell therapy processes.
Responsibilities
- Lead late-stage cell therapy process development within Process Engineering and manage multiple development projects.
- Direct engineers and scientists in study design, laboratory execution, and technical report authoring.
- Conduct risk assessments and data analyses; write technical reports and present study outcomes to cross-functional teams and governance forums.
- Review batch records, assess deviations, and trend data to evaluate manufacturing process robustness.
- Apply AI-enabled tools and digital analytics to data review, trend analysis, batch record evaluation, and process understanding.
- Build, develop, and manage a high-performing team of process development scientists and engineers.
- Establish project priorities, resource allocation, and departmental objectives, and foster a collaborative, innovation-driven culture.
- Support PPQ activities, including protocol and batch record authoring and planning.
- Support technology transfer to internal manufacturing sites, including make-a-batch assessments and drafting manufacturing batch records.
- Lead commercial product lifecycle management, including process monitoring, continuous improvement, post-approval changes, comparability assessments, and regulatory commitments.
- Partner with Manufacturing, Quality, Regulatory Affairs, and Technical Operations to implement improvements, maintain process control, and support commercial readiness.
- Serve as the Process Development and Engineering subject matter expert for manufacturing operations and provide scientific support for deviations, investigations, atypical events, and process-related issues.
- Lead root cause analyses, impact assessments, and CAPA development using data-driven and risk-based approaches.
- Contribute to authoring and reviewing CMC documentation, including process descriptions, characterization summaries, PPQ protocols and reports, and control strategy elements.
- Support BLA/MAA submissions and responses to regulatory questions about cell therapy manufacturing.
- Work with analytical sciences, quality, regulatory, and manufacturing teams to ensure end-to-end process alignment.
- Represent cell therapy characterization activities in technical meetings, reviews, and governance discussions.
Benefits
- Eligibility for short-term incentive bonuses.
- Equity-based awards for salaried roles.
- Qualified retirement programs.
- Paid time off, including vacation, holidays, and leaves.
- Health coverage.
- Dental coverage.
- Vision coverage.
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What This Job Offers
Job Type
Full-time
Career Level
Director
