Senior Director, Cell Therapy Process Development

Made Scientific; Princeton (NJ); On-site; USD 180,000 - 240,000; Full time

Job summary

Made Scientific seeks an Associate Director of Process Development to lead autologous and allogeneic cell therapy manufacturing process development from preclinical through commercial scale in a CDMO setting.

You will partner with clients, transfer technology, drive process characterization, and ensure compliance with cGMP, FDA, EMA and ICH standards across programs. Strong leadership and communication are essential.

Qualifications

• PhD or MS in Biochemical Engineering, Cell Biology, Bioengineering, Biotechnology, or related field.
• 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.
• Deep knowledge of cell culture and cell expansion technologies; viral vector transduction or gene editing workflows; closed and automated cell therapy manufacturing platforms; cryopreservation and fill-finish for cell therapy.

Responsibilities

• Provide scientific and technical leadership for cell therapy manufacturing processes including upstream cell expansion, gene modification, harvest, formulation, and cryopreservation.
• Serve as the 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 of manufacturing processes across CDMO facilities.

Skills

Leadership

Cross-functional leadership

Project management

Communication

Client interaction

Education

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

Tools

Statistical process monitoring

Data analytics tools

Job description

Made Scientific seeks an Associate Director of Process Development to lead autologous and allogeneic cell therapy manufacturing process development from preclinical through commercial scale in a CDMO setting.

You will partner with clients, transfer technology, drive process characterization, and ensure compliance with cGMP, FDA, EMA and ICH standards across programs. Strong leadership and communication are essential.