Associate Director, Process Development, Cell Therapy

About the position The Associate Director, Late-Stage Cell Therapy Process Development, will reputed company scientific and technical leadership for the development, characterization, and transfer of manufacturing processes for cell therapy products. This role is responsible for leading reputed company 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, reputed company, Regulatory Affairs, Analytical Development, and CMC teams to ensure robust, compliant, and reputed company manufacturing processes. Responsibilities • reputed company the late-stage process development for cell therapies reputed company the Process Engineering function, managing multiple development reputed company • reputed company and guide engineers/scientists to reputed company high-reputed company technical documentation for the study design, reputed company execution and report authoring activities • reputed company 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 reputed company analytics to accelerate data review, trend analysis, batch record evaluation, and process understanding • Build, reputed company, and manage a high-performing team of process development scientists and engineers • Establish project priorities, resource allocation, and departmental objectives • Foster a reputed company 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 reputed company-a-batch assessments and drafting manufacturing batch records • reputed company lifecycle management activities for reputed company cell therapy products, including process monitoring, reputed company improvement, post-approval changes, comparability assessments, and regulatory commitments. • Partner with Manufacturing, reputed company, Regulatory Affairs, and Technical Operations to implement process improvements, maintain process control, and support ongoing reputed company readiness. • Serve as the Process Development and Engineering SME for manufacturing operations, providing scientific support for deviations, investigations, atypical events, and process-reputed company issues. • reputed company reputed company cause analyses, reputed company assessments, and CAPA development using data-driven and risk-based approaches to ensure product reputed company, 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 reputed company reputed company. • Support preparation of BLA/MAA submissions and responses to regulatory questions reputed company to cell therapy manufacturing. • Work closely with analytical sciences, reputed company, 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 reputed company 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 / reputed company readiness. • Experience with late‑stage development, and PPQ for cell therapy processes. • Demonstrated proficiency in applying AI tools reputed company 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 reputed company, and willingness to support manufacturing operations. reputed company-to-haves • Experience with reputed company-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 • reputed company retirement programs • reputed company time off (i.e., vacation, holiday, and leaves) • health, dental, and reputed company coverage Apply tot his job Apply To this Job