GMP Facilities Manager – Gene Therapy Vector Facility (London) BioTalent have partnered with a gene therapy fector Facility to find an experienced GMP Facilities Manager to join them.
These facilities, which include cleanrooms, storage areas, and Quality Control spaces, play a key role in translating innovative medical research into clinical therapies for cancer and rare diseases.
This role also offers the opportunity to contribute to the design, commissioning, and qualification of new cleanroom suites as part of the facility's expansion.
Key Responsibilities: Ensure GMP facilities meet Pharmaceutical Quality System (PQS) and relevant GMP regulations.
Oversee Planned Preventative Maintenance and facility requalification.
Manage relationships with external contractors to resolve facility, HVAC, and equipment issues.
Collaborate with the Cell Therapy Unit (CTU) to maintain GMP rooms.
Maintaining cutting-edge GMP facilities licensed by the MHRA, supporting the manufacture of Advanced Therapy Medicinal Products (ATMPs) and related materials.
Lead disaster management and contingency planning efforts.
Ensure compliance with Health & Safety policies, including writing risk and COSHH assessments.
Establish and maintain effective relationships with internal departments, including Estates, Procurement, and Finance.
Key Experience Required: Proven experience in managing GMP facilities, ideally in the pharmaceutical or biotech sector.
Strong understanding of Pharmaceutical Quality Systems (PQS) and GMP regulations.
Experience coordinating facility maintenance and managing external contractors.
Knowledge of cleanroom operations and HVAC systems.
Experience in disaster management and contingency planning.
Familiarity with Health & Safety compliance, including risk and COSHH assessments.
Excellent communication skills and ability to work collaboratively with internal teams and external partners.