GMP Facility Manager

About the role

The Gene Therapy Vector Facility (GTVF) manufactures a variety of Advanced Therapy Medicinal Products (ATMPs) and starting materials, in state-of-the-art Good Manufacturing Practice (GMP) facilities for treatment of cancer and rare diseases. The GMP facilities are licenced by the MHRA for the production of IMP/ATMPs and starting materials to EU GMP standards and comprises several grade D cleanrooms, stock areas, fridge/freezer rooms, product storage area and Quality Control areas. This post supports the translation of cutting-edge medicinal research into clinical application. The position is based in a team with an excellent track record in both basic and translational research.

The GMP Facility Manager will have day to day responsible for ensuring that the CGT-K GMP facilities at the Denmark Hill campus are maintained in a fit-for-purpose state that is complaint with the Pharmaceutical Quality System (PQS) and relevant GMP regulations.  The role holder will also liaise with the Facility Manager at the KCH Cell Therapy Unit (CTU) to assist in maintaining the CGT-K GMP rooms within the CTU where required. The role will include organising and overseeing the annual Planned Preventative Maintenance and facility requalification along with liaising with external contractors/ suppliers to identify and rectify issues with the facility fabric, HVAC and associated equipment. Disaster management and contingency planning will be a key aspect of the role. The Facility Manager will have a key role in ensuring compliance with Health & Safety policies of the College including writing Health and Safety risk assessments and COSHH assessments. The role holder will need to establish effective relationships with departments within the College including the Estates and Facilities, Procurement and Finance.

The GMP activities and facilities are currently undergoing expansion. This offers an exciting opportunity to contribute to the design, build, commissioning and qualification of new and refurbished cleanroom suites. 

The GMP Facility Manager will be responsible to the Head of Supply Chain and Facility Management, CGT-K.

This is a full time post and will be offered on an indefinite contract.

About You

To be successful in this role, we are looking for candidates to have the following skills and experience:

Essential criteria

1. Hands-on experience of the day to day running of a cleanroom facility, working with compressed gases and cryostore facilities
2. Experience of the validation of equipment (IQ/OQ/PQ) for use in a GMP facility
3. Experience in establishing and maintaining a PPM program for a GMP facility
4. Working knowledge of Pharmaceutical Quality Systems including change control, deviations and CAPA
5. Experience in writing S.O.P, H&S risk assessments, COSSH 
6. Working knowledge of EU GMP in particular qualification and validation
7. Good organisational and time management skills, excellent interpersonal skills and demonstrated ability to form effective working relationships with key stakeholders
8. Degree in Biological Sciences (or similar) or engineering

Desirable criteria

1. Experience of all aspects of QA/QC in relation to production of ATIMPs in particular Change Control, Document Control, Process Validation, Equipment Management CAPA, Quality Risk Management
2. Working knowledge of a facility monitoring system (FMS)
3. In depth understanding of engineering infrastructure that supports cleanroom facilities (HVAC, BMS etc)

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