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Job id: 090627. Salary: £37,332 – £42,099 per annum, including London Weighting Allowance.

Posted: 05 June 2024. Closing date: 23 June 2024.

Business unit: Faculty of Life Sciences & Medicine. Department: Gene Therapy and Regenerative Medicine.

Contact details: Heather Kneale. Heather.kneale@kcl.ac.uk

Location: Guy's Campus. Category: Professional & Support Services.

About us

The Centre for Gene Therapy & Regenerative Medicine (CGTRM), in partnership with KCL Gene Therapy Vector Facility (GTVF), manufactures ATMPs for a wide variety of novel gene and cell therapies for the treatment of cancers to rare diseases. This is an opportunity to work within one of the largest academic GMP facilities in Europe focusing on the delivery of gene therapy products for early phase clinical trials.

About the role

This role is for a qualified and trained GMP Production Scientist who has been working with the development and manufacturing or testing and release of AAV vectors or other gene therapy products IMPs in an academic or industry-led GMP manufacturing facility. The work will include day-to-day operations and execution of GMP production runs operations, ensuring the schedule is followed by participating in development, validation and manufacturing processes, liaising with the quality and technical team, preparing GMP compliant batch documentation, identifying bottlenecks and reporting to the Production Manager. In fulfilling these tasks, a strong background in cGMP and interpersonal skills will be essential, but training (both in-house and through external courses) will be provided, as deemed necessary.

You will be required to participate in initial site start-up activities related to facility and equipment qualification, process validation activities leading to site readiness and GMP inspection of the AAV vector manufacturing facility including implementation of electronic quality system and batch record documentation, and be trained in the manufacturing and release of gene therapy products at Guy’s or Denmark Hill campus. Further, the post holder may be required to take an active role in other projects within the CGTRM/GTVF and will execute experiments independently or in collaboration with other group members, as required by manager or head.

You will have expertise working in a GMP licensed facility and be trained in aseptic techniques and cell culture techniques, process development, validation of process for GMP batch manufacturing. You will be trained in ensuring compliance to pharmaceutical quality system, interacting with quality assurance, compiling laboratory reports and product specification file, executing electronic batch manufacturing records leading to approval, batch certification and QP release. You will be assigned duties within a team and interact with Production staff performing upstream processing (thawing to crude bulk harvest) and downstream processing (bulk purification to final vialed product) operations, after completion of process optimisation and development, and process validation for GMP batch manufacturing and release of products for clinical trials.

This post will be offered on a fixed-term contract until 30th September 2025. 

This is a full-time post - 100% full time equivalent.

About you

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

Essential criteria

  1. Minimum level 6 qualification, e.g. relevant undergraduate degree or equivalent OR considerable knowledge and skills gained through work experience, with GMP training and ATMP manufacturing experience for the release of viral gene therapy products as IMPs/INDs for clinical trials
  2. Knowledge of the field of gene and cell therapy, and expertise in translational research methodology with an organised and systematic approach to development and manufacturing
  3. Background in bioprocess engineering, and hands-on experience in aseptic handling, cellular and bioprocessing techniques, and trained as Production Technician or Scientist for GMP manufacturing, leading to release of gene/cell therapy IMPs/ MS products in a licensed GMP facility in university or industry.  Trained in bioprocess optimisation and development, process validation, GMP manufacturing of MCB/WCB, gene/cell therapy products for pre-clinical and clinical trials in a reputed academic organisation or industry, with a commitment to ongoing professional development
  4. Experience in Production related operations in a licensed GMP facility with a good knowledge of regulations and best practice governing cGMP compliance including qualification of staff, cleanroom and equipment, in addition to approved manufacturing procedures for use in GMP manufacturing and product release
  5. Experience in working with quality team ensuring document control, training records, validation including calibration and maintenance, audit, change control, deviations, CAPA, OOS, quality risk management, supplier qualification and approval, etc are in compliance with PQS
  6. Working knowledge of EudraLex - Volume 4 - Good Manufacturing Practice (GMP) guidelines, current MHRA Orange Guide including EU GMP regulations for ATMP manufacturing for clinical trials
  7. Awareness or knowledge in compiling Site Validation Master Plan covering aspects of site/equipment validation, calibration and maintenance requirements, Process Validation Master Plan covering aspects of process validation and transfer to GMP Batch Manufacturing Record for QP review and release
  8. Trained in relevant aseptic, cellular and bioprocess techniques for development, validation and manufacturing of gene therapy vectors. Experience in (i) aseptic techniques related to cell culture, product harvest, product purification, formulation and final product filling in a GMP facility, (ii) preparation for internal, external and regulatory audits, executing operations leading to GMP inspection readiness and approval
  9. Clear spoken and written communication skills and strong interpersonal skills
  10. Competent in completing and handling electronic or paper-based quality/batch documentation and records for IMPs/MS products

Desirable criteria

  1. Experience in supporting quality and/or manufacturing team for implementation of electronic quality documentation and electronic batch records respectively
  2. Experience in process development, manufacturing and release of AAV gene therapy products in ongoing clinical trials
  3. Experience in GMP facility start-up from facility and equipment qualification to development, validation and GMP manufacturing, and handled AAV gene therapy projects successfully from pre-clinical to batch manufacturing, CMC documentation and IMPD/IND approval
  4. Experience in working with production or development team, comprising of development, technology transfer and manufacturing, and quality assurance staff for coordinating milestones related to quality assurance, process development, audits (internal, external and regulatory), and assisted in providing relevant information to internal and external stake holders, leading to GMP inspection readiness and approval
  5. Experience in working with a team to meet agreed timelines for batch manufacturing and release of gene therapy products for clinical trials, providing support beyond core hours when required

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 are able to offer sponsorship for candidates who do not currently possess the right to work in the UK. Please note this is dependent on the salary offered which is based on your experience and will be discussed at the offer stage.