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Senior GMP Production Manager

King's College London - Centre for Cell and Gene Therapy (CCGT), Medical and Molecular Genetics

Location: London
Salary: £56,060 to £64,405 per annum, including London Weighting Allowance. Grade 8
Hours: Full Time
Contract Type: Fixed-Term/Contract
Placed On: 13th September 2021
Closes: 28th September 2021
Job Ref: 031566
 

Building and Campus: Guy’s Tower, Guy’s Campus & Denmark Hill Campus

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

Job description

Role purpose

The Centre for Cell and Gene Therapy (CCGT) 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.

This role is for a Senior GMP Production Manager who has been working in the production department involved in the development and manufacturing of AAV vectors or other gene therapy products in an academic or industry-led GMP manufacturing facility and will report to Head of Production or, in his absence, CCGT Director. It is an opportunity to work with a world leading leading gene therapy group based at Guy’s and/or Denmark Hill campus on the delivery of AAV and Lenti viral gene therapy products for early phase clinical trials.

Role profile

As part of the role profile, the post holder will possess sufficient previous experience as Production Manager in a Gene Therapy manufacturing GMP facility and be named as designated contact for Production Manager on the GMP License. The Production Manager should be able to manage a team of production and non-production staff and be capable of providing detailed daily instructions and explanations about the production activities of CCGT both orally and in writing to meet the milestones/objectives of the projects. Accordingly, they will be authoring production documents such as Manufacturing Records, Standard Operating Procedures, validation protocols and deviation reports. In addition to the core role, the postholder will take a leading and pro-active role in site start-up activities related to implementation of electronic quality documentation, facility and equipment qualification, GMP readiness and inspection of the AAV GMP manufacturing faciility, and if required, supporting manufacturing and release of gene therapy products within the GMP manufacturing facility at Denmark Hill. Further, the post holder is required to manage the process development team and support other development projects within the group, and will design and manage experiments in collaboration with other CCGT members, as required. In addition to hands-on supervision and training, they must be able to effectively communicate on compliance-related batch and regulatory documentation. As part of management role, they will ensure all tasks are risk assessed and performed consistently with a high level of confidence, clarity, concentration and integrity, including safe handling of different types of equipment, awareness and following of corresponding safety procedures, and in compliance with various regulatory requirements.

This post will be offered on a fixed-term contract for 48 months

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

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