Associate Director, Process Development, Cell Therapy

Position Summary   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.   Key Responsibilities   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   &   Tech nology   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.   Required Qualifications   • Ph.D. in Chemical Engineering, Biochemical Engineering, Biological Sciences, Biotechnology, Pharmaceutical Sciences, or related discipline with   6 + years of industr