About the position
The Associate Director, Late-Stage Cell Therapy Process Development, will provide scientific and technical leadership for the development, characterization, and transfer of manufacturing processes for cell therapy products. This role is responsible for leading a team of scientists and engineers supporting process development activities from clinical development through commercialization, including BLA and global regulatory submissions. The successful candidate will partner cross-functionally with Manufacturing, Quality, Regulatory Affairs, Analytical Development, and CMC teams to ensure robust, compliant, and scalable manufacturing processes.
Responsibilities
• Lead the late-stage process development for cell therapies within the Process Engineering function, managing multiple development projects
• Direct and guide engineers/scientists to deliver high-quality technical documentation for the study design, laboratory execution and report authoring activities
• Perform risk assessment, data analysis, write technical reports, and present outcome of the studies to cross‑functional teams and governance forums
• Conduct batch record review, deviation assessment, and data trending to ensure robustness of cell therapy manufacturing processes
• Apply AI‑enabled tools and digital analytics to accelerate 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
• Foster a collaborative and innovation-driven culture
• Support PPQ activities including but not limited to protocol authoring, batch record authoring and planning
• Support technology transfer of cell therapy processes to internal manufacturing sites including make-a-batch assessments and drafting manufacturing batch records
• Lead lifecycle management activities for commercial cell therapy products, including process monitoring, continuous improvement, post-approval changes, comparability assessments, and regulatory commitments.
• Partner with Manufacturing, Quality, Regulatory Affairs, and Technical Operations to implement process improvements, maintain process control, and support ongoing commercial readiness.
• Serve as the Process Development and Engineering SME for manufacturing operations, providing 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 to ensure product quality, compliance, and uninterrupted manufacturing operations.
• Contributes to authoring and reviewing CMC documentation, including cell therapy process descriptions, characterization summaries, PPQ protocols and reports, and control strategy elements.
• Support preparation of BLA/MAA submissions and responses to regulatory questions related to cell therapy manufacturing.
• Work closely 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.
Requirements
• Ph.D. in Chemical Engineering, Biochemical Engineering, Biological Sciences, Biotechnology, Pharmaceutical Sciences, or 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.
• Demonstrated 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.
• Ability to operate effectively in fast‑paced, late‑stage development environments.
• Scientific curiosity, 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.
Benefits
• qualified retirement programs
• paid time off (i.e., vacation, holiday, and leaves)
• health, dental, and vision coverage