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 industry experience; or M.S. with 1 0 + years of relevant experience; or B.S. with 1 2 + 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.   Preferred Qualifications   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.   Key Competencies   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.   The annual base pay for this position ranges from $138K to $207K. Our positions offer eligibility for multiple incentives an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans . # Hybrid # Cell Therapy Date Posted 15-Sep-2026 Closing Date 24-Sep-2026 Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the correspondin