Associate Director, Process Development, Cell Therapy

About the Company

Responsibilities

• ● 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 industry experience; or M.S. with 1 0 + years of relevant experience; or B.S. with 1 2 + years of relevant experience.