Associate Director, Process Development, Cell Therapy

About the Role

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 leads 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.

Responsibilities

• Technical Leadership
  • Lead 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 study design, laboratory execution, and report authoring.
  • Perform risk assessment, data analysis, write technical reports, and present outcomes 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 & Technology Transfer Support
  • Support PPQ activities including 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
  • Contribute 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.

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.

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.

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.

Pay

The annual base pay for this position ranges from $138,000 to $207,000. Positions offer eligibility for multiple incentives, including short-term incentive bonuses, equity-based awards for salaried roles, and commissions for sales roles.

Benefits

• Qualified retirement programs.
• Paid time off (vacation, holiday, and leaves).
• Health, dental, and vision coverage in accordance with the terms of the applicable plans.

Schedule

Hybrid