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 & Technology 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 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. 

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