Director, GMP Operations - Cell Therapy Manufacturing

Century Therapeutics, Inc.; Branchburg Township (NJ); In loco; USD 195.000 - 218.000; Tempo pieno

Descrizione del lavoro

Century Therapeutics, Inc. in New Jersey seeks a Director, GMP Operations to provide strategic and operational leadership for Century’s GMP manufacturing facility, including validation, warehouse operations, and CQV processes.

You will own site systems, oversee inventory, and ensure timely supply for Phase 1 clinical trials, collaborating across Quality, Supply Chain, MSAT, EHS and Facilities. This on-site role offers a competitive salary and strong benefits.

Competenze

• Advanced knowledge of cGMP/biopharmaceutical regulations.
• Advanced cell therapy manufacturing experience including aseptic processing, media prep, cell banking, culture, and cryopreservation.
• Strong knowledge of current validation best practices, including government regulations and GxPs.
• Experience with ERP systems for inventory management and QMS for master batch records.
• Experience leading teams or vendor relationships is a plus.
• Ability to read, write and interpret technical/quality documents (SOPs, deviations, CAPAs).
• Proven ability to lead in a fast-paced, hands-on environment and adapt priorities.
• Ability to work in controlled clean rooms with appropriate PPE.

Mansioni

• Lead cell therapy GMP operations in Century’s GMP facility.
• Own and maintain site systems including inventory management and validation.
• Partner cross-functionally to ensure supply of clinical material for Phase 1 trials.
• Create, review, and approve SOPs, batch records, material specifications, and validation reports.
• Implement a Process Validation lifecycle including Aseptic Process Simulation for cell therapy manufacturing.
• Build a collaborative environment with decisive decision making and accountability.
• Ensure timely closure of deviations, CAPAs, and change controls.
• Build cross-functional relationships with Quality, Supply Chain, MSAT, EHS and Facilities.

Conoscenze

GMP operations leadership

cell therapy manufacturing

validation & CQV

SOPs & batch records

cross-functional collaboration

Formazione

BS in biopharmaceutical field

MS in biopharmaceuticals

Strumenti

ERP systems

QMS electronic system for MBRs

Descrizione del lavoro

Century Therapeutics, Inc. in New Jersey seeks a Director, GMP Operations to provide strategic and operational leadership for Century’s GMP manufacturing facility, including validation, warehouse operations, and CQV processes.

You will own site systems, oversee inventory, and ensure timely supply for Phase 1 clinical trials, collaborating across Quality, Supply Chain, MSAT, EHS and Facilities. This on-site role offers a competitive salary and strong benefits.