Associate Director, Process Development

Job Description

Job Description

Position Summary

The Associate Director of Process Development provides scientific and technical leadership for the development and lifecycle management of autologous and allogeneic cell therapy manufacturing processes. This role leads process development activities from preclinical through commercial manufacturing, supporting scalable, robust, and compliant processes within a CDMO environment. The position partners cross-functionally and with clients to advance programs, technology transfer, and continuous process improvement.

Key Responsibilities

• Provide scientific and technical leadership for cell therapy manufacturing processes including upstream cell expansion, gene modification, harvest, formulation, and cryopreservation.

• Serve as the technical subject matter expert (SME) for manufacturing processes supporting client programs.

• Assist in troubleshooting and root cause analysis for manufacturing deviations, investigations, and CAPAs.

• Drive implementation of process development methodologies

• Develop and review experimental plans, bill of materials, process descriptions, equipment SOPs, risk assessments, and gap analyses.

• Ensure successful scale-up and scale-out of manufacturing processes across CDMO facilities when applicable.

• Assist in process characterization, comparability studies, and validation support.

• Provide real-time support to GMP manufacturing operations for clinical and commercial batches.

• Drive thought Leadership on Cell Therapy Manufacturing

• Provide expertise into business development processes, to include review of proposals, contracts and marketing material.

• Review batch records, deviations, and change controls related to process changes as needed.

• Present technical updates during client meetings and governance reviews.

• Support proposal development, technical due diligence, and new program onboarding.

• Ensure PD activities align with cGMP, FDA, EMA, and ICH regulatory requirements.

• Contribute to regulatory filings including INDs, BLAs, and comparability packages.

• Support regulatory inspections and client audits.

• Build and lead a high-performing PD team, including scientists and engineers.

• Provide mentorship, technical guidance, and performance management.

• Develop PD strategy aligned with organizational growth and client pipeline.