Associate Director, Cell Therapy Process Development

Made Scientific, Inc.; East Norriton Township (Montgomery County); On-site; USD 180,000 - 240,000; Full time

Job summary

Made Scientific, Inc. is seeking an Associate Director of Process Development to lead the lifecycle management of autologous and allogeneic cell therapy manufacturing processes in a CDMO setting.

You will drive scalability, compliance, and client interactions from preclinical to commercial stages. The role requires deep expertise in cell therapy, cross-functional leadership, and regulatory readiness across FDA/EMA frameworks, with mentorship and strategic PD planning to support growth and client

Qualifications

• 15+ years of experience in biopharmaceutical manufacturing or process development.
• 5+ years of leadership experience in MSAT, technical operations, or process development.
• Strong experience with cell therapy manufacturing (e.g., CAR-T, TCR-T, NK cells, stem cell therapies).
• Experience in CDMO environments strongly preferred.

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 SME for manufacturing processes supporting client programs.
• Assist in troubleshooting and root cause analysis for 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 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, including review of proposals, contracts, and marketing material.

Skills

Leadership

Project management

Cross-functional collaboration

Communication

GMP knowledge

Cell therapy manufacturing

Regulatory understanding

Education

PhD or MS in Biochemical Engineering, Cell Biology, Bioengineering, Biotechnology, or related field

Job description

Made Scientific, Inc. is seeking an Associate Director of Process Development to lead the lifecycle management of autologous and allogeneic cell therapy manufacturing processes in a CDMO setting.

You will drive scalability, compliance, and client interactions from preclinical to commercial stages. The role requires deep expertise in cell therapy, cross-functional leadership, and regulatory readiness across FDA/EMA frameworks, with mentorship and strategic PD planning to support growth and client