The Cell and Gene Therapy, King's (CGT-K), group 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 of 6 grade D cleanrooms, stock areas, freezer / refrigeration room, 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 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 Quality Director at the KCH Cell Therapy Unit (CTU) to assist in maintaining the CGT-K GMP rooms within the CTU. The role will include organising and overseeing the annual Planned Preventative Maintenance and facility requalification along with liaising with external contractors/ suppliers to problem solve issues with the facility fabric, HVAC and equipment. Disaster management and contingency planning will be a key aspect of the role. The Facility Manager will have a lead role in ensuring compliance with Health & Safety policies of the College including writing of Health and Safety risk assessments and COSHH assessments. The role holder will assist in determining an annual running budget for the facilities and subsequently manage the budget. The role holder will need to establish effective relationships with Departments within the College including the Estates and Facilities, Procurement and Finance.
The GMP activties and facilities are currently undergoing expansion. This offers an exciting opportunity to play a significant role in design, build, commissioning and qualification of new and refurbished cleanroom suites.
The Facility Manager will be responsible to the Head of Quality, CGT-K.
This post will be offered on an indefinite contract.
This is a full-time post.
- Undertake the day-to-day management of the CGT-K GMP facilities and ensure that the facilities are maintained in a fit-for- purpose state at all times by working closely with Technical staff, Head of Production and Head of Quality.
- Develop a thorough understanding of the GMP Facility including the HVAC system, Environmental Monitoring System and equipment.
- Organise the routine external maintenance, servicing and annual requalification of the GMP facilities and equipment, ensuring compliance with applicable GMP and HTA requirements.
- Be the principal link with the College Estates Departments to ensure the satisfactory service, maintenance and security of the CGT-K GMP facilities and associated areas, plant and equipment.
- Ensure the cleaning and EM regimes are maintained.
- Undertake the purchasing of new equipment according to in-house procedures including establishing User Requirement Specifications in conjunction with end users. Liaising with the central procurement team to ensure the procurement meets KCL procurement rules.
- Oversee the IQ/OQ/PQ of the equipment.
- Prepare a disaster management and contingency plan for the CGT-K GMP facilities in conjunction with the Head of Production, Head of Quality and Head of Analytical platforms.
- Develop a plan to ensure 24-hour emergency contacts for the CGT-K GMP suites and associated areas and establish and on-call rota.
- Take a leading role in ensuring compliance with Health & Safety policies of the College including writing of Health and Safety risk assessments and COSHH assessments.
- Ensure waste from the GMP and QC activties is disposed of in an appropriate manner in line with KCL requirements.
- Provide training to new staff on the use of the GMP facilities and equipment, as applicable.
- Work with the College central teams to set-up of service agreements and contracts with external suppliers in relation to GMP facility and equipment maintenance.
- Manage the budget of the GMP facilities
- Play a key role in the design, build, commissioning and qualification of new GMP facilities and the refurbishment / upgrade of existing facilities.
- Assist in ensuring the compliance of the GMP facility with relevant GMP guidance and regulations including:
- Keeping the GMP facility and equipment records in accordance with the PQS.
- Ensuring SOPs relating to facility/ equipment use and maintenance are in place,
- Ensuring an effective planned preventive maintenance system is in place,
- Taking a lead role in investigating and close out of deviations and quality exceptions related to facility and equipment
- Taking a lead role in raising and executing change controls related to facilities or equipment,
- Participating in internal, client and regulatory audits,
- Reporting and discussing all GMP compliance issues with senior Quality staff.
The above list of responsibilities may not be exhaustive, and the post holder will be required to undertake such tasks and responsibilities as may reasonably be expected within the scope and grading of the post.
Skills, knowledge, and experience
- Hands-on experience of the day to day running of a cleanroom.
- Experience of the validation of equipment (IQ/OQ/PQ) for use in a GMP facility.
- Experience in establishing and maintaining a PPM program for a GMP facility.
- Working knowledge of Pharmaceutical Quality Systems including change control, deviations and CAPA.
- Experience in writing standard operating procedures
- Experience of writing health and safety risk assessments and COSSH
- Working knowledge of EU GMP in particular qualification and validation
- Good Organisational and time management skills.
- Excellent interpersonal skills and demonstrated ability to form effective working relationships with key stakeholders.
- Degree in Biological Sciences or engineering.
- Familiarity with Environmental/ Facility Monitoring Systems.
- Demonstrated Project management skills.
- Knowledge of GMP facility design, commissioning and qualification gained from participating in such activities.
- Budget management experience.
This post is subject to Occupational Health clearance.