Back to search results

GMP Facility Manager

King's College London - Gene Therapy Vector Facility (GTVF)

Location: London
Salary: £44,105 to £51,485 per annum, including London Weighting Allowance
Hours: Full Time
Contract Type: Permanent
Placed On: 23rd October 2024
Closes: 5th November 2024
Job Ref: 097605
 

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)
We value your feedback on the quality of our adverts. If you have a comment to make about the overall quality of this advert, or its categorisation then please send us your feedback
Advert information

Type / Role:

Subject Area(s):

Location(s):

Job tools
 

PhD Alert Created

Job Alert Created

Your PhD alert has been successfully created for this search.

Your job alert has been successfully created for this search.

Ok Ok

PhD Alert Created

Job Alert Created

Your PhD alert has been successfully created for this search.

Your job alert has been successfully created for this search.

Manage your job alerts Manage your job alerts

Account Verification Missing

In order to create multiple job alerts, you must first verify your email address to complete your account creation

Request verification email Request verification email

jobs.ac.uk Account Required

In order to create multiple alerts, you must create a jobs.ac.uk jobseeker account

Create Account Create Account

Alert Creation Failed

Unfortunately, your account is currently blocked. Please login to unblock your account.

Email Address Blocked

We received a delivery failure message when attempting to send you an email and therefore your email address has been blocked. You will not receive job alerts until your email address is unblocked. To do so, please choose from one of the two options below.

Max Alerts Reached

A maximum of 5 Job Alerts can be created against your account. Please remove an existing alert in order to create this new Job Alert

Manage your job alerts Manage your job alerts

Creation Failed

Unfortunately, your alert was not created at this time. Please try again.

Ok Ok

Create PhD Alert

Create Job Alert

When you create this PhD alert we will email you a selection of PhDs matching your criteria.When you create this job alert we will email you a selection of jobs matching your criteria. Our Terms and Conditions and Privacy Policy apply to this service. Any personal data you provide in setting up this alert is processed in accordance with our Privacy Notice

Create PhD Alert

Create Job Alert

When you create this PhD alert we will email you a selection of PhDs matching your criteria.When you create this job alert we will email you a selection of jobs matching your criteria. Our Terms and Conditions and Privacy Policy apply to this service. Any personal data you provide in setting up this alert is processed in accordance with our Privacy Notice

 
 
More jobs from King's College London

Show all jobs for this employer …

More jobs like this
Join in and follow us

Browser Upgrade Recommended

jobs.ac.uk has been optimised for the latest browsers.

For the best user experience, we recommend viewing jobs.ac.uk on one of the following:

Google Chrome Firefox Microsoft Edge