GMP Facility Manager

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About us

The King's College London Gene Therapy Vector Facility (GTVF) provides comprehensive GMP-grade viral vector manufacturing services. This includes Lentiviral Vector (LV), Retroviral Vector (RV) and Adeno-Associated Viral Vector (AAV) production for early-phase clinical trials, alongside substantial programmes in process innovation, knowledge transfer and training to address critical skills shortages.

In partnership with the Network of Innovation Hubs, our vision is to ensure that the UK capitalises on its outstanding academic medical research to deliver novel gene therapies to patients, providing transformative treatments for currently intractable conditions, and generating a vibrant economic landscape.

The GTVF is run by a large, industry-leading team of 50 people who have extensive experience in delivering end-to-end viral vector manufacture for both academic and commercial clients, with a focus on early-stage clinical trials.

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 post will be offered on an indefinite contract.

This is a full-time post.

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)

Downloading a copy of our Job Description

Full details of the role and the skills, knowledge and experience required can be found in the Job Description document, provided at the bottom of the next page after you click "Apply Now". This document will provide information of what criteria will be assessed at each stage of the recruitment process.

Further Information

We pride ourselves on being inclusive and welcoming. We embrace diversity and want everyone to feel that they belong and are connected to others in our community.

We are committed to working with our staff and unions on these and other issues, to continue to support our people and to develop a diverse and inclusive culture at King's.

We ask all candidates to submit a copy of their CV, and a supporting statement, detailing how they meet the essential criteria listed in the advert. If we receive a strong field of candidates, we may use the desirable criteria to choose our final shortlist, so please include your evidence against these where possible.

To find out how our managers will review your application, please take a look at our ' How we Recruit ' pages.

We not able to offer sponsorship for candidates who do not currently possess the right to work in the UK.