Associate Director, Process Development, Cell Therapy

AstraZeneca•Santa Monica, CA

1d•$138,000 - $207,000•Hybrid

About The Position

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.

Requirements

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.
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.

Nice To Haves

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.

Responsibilities

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
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
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
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.
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.
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.
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.