Cell Therapy Process Development Leader

Made Scientific, Inc.; Eagleville (PA); In loco; USD 200.000 - 280.000; Tempo pieno

Descrizione del lavoro

Made Scientific, Inc. is seeking an Associate Director of Process Development to lead cell therapy manufacturing process development from preclinical to commercial stages in a CDMO setting, driving scalable, robust, and compliant operations.

The role requires strong cross-functional leadership, experience with tech transfer, process validation, and regulatory filings, plus the ability to mentor a high-performing PD team and partner with clients on proposals and due diligence.

Competenze

• 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.

Mansioni

• 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 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.

Conoscenze

Cross-functional leadership

Project management

Excellent written and verbal comms

Client-facing experience

Biopharmaceutical manufacturing exp.

Formazione

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

Strumenti

CliniMACS Prodigy

Lonza Cocoon

Descrizione del lavoro

Made Scientific, Inc. is seeking an Associate Director of Process Development to lead cell therapy manufacturing process development from preclinical to commercial stages in a CDMO setting, driving scalable, robust, and compliant operations.

The role requires strong cross-functional leadership, experience with tech transfer, process validation, and regulatory filings, plus the ability to mentor a high-performing PD team and partner with clients on proposals and due diligence.