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Senior GMP Quality Control Technician

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

Location: London
Salary: £38,304 to £45,026 per annum, including London Weighting Allowance. Grade 6
Hours: Full Time
Contract Type: Fixed-Term/Contract
Placed On: 8th September 2021
Closes: 28th September 2021
Job Ref: 031547
 

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

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

Role profile

As part of the role profile, the senior GMP Quality Control Technician will be required to participate in initial site start-up activities related to facility and equipment qualification, process/QC 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 support other projects within the CCGT group, and will design and execute experiments independently or in collaboration with other group members, as required by manager or head.

The postholder will have sufficient expertise working in a GMP licensed facility and be competent in molecular, cellular and analytical techniques, QC development, validation of quality control assays for in-process, stability and release testing including processing of samples for Crude Bulk Harvest, Drug Substance & Drug Product, including stability testing. They will be competent in ensuring compliance to pharmaceutical quality system, interacting with quality assurance, compiling laboratory reports and ensuring QC testing as per product specification file, reviewing electronic quality records for quality approval, batch certification and QP release. They will be competent working with supervising their team and interacting with QC staff performing analytical testing (QC assay development and validation) operations, covering the different stages of product life cycle from vector design, plasmid specifications, process/ QC optimisation and development, validation, QC testing, stability assays and delivery of products to clinical trial sites.

This post will be offered on a fixed-term contract for 30 months in the first instance

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

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