Associate Director, Process Development, Cell Therapy

Associate Director, Late-Stage Cell Therapy Process Development

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.

Technical Leadership

• 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

Team Leadership and Management

• 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

PPQ & Technology Transfer

• 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

Lifecycle Management

• 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.

Manufacturing Support & Scientific Deviation Management

• 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.

Regulatory Support

• 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.

Cross-Functional Collaboration

• 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.

• 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.

• Experience…