|Salary:||£38,304 to £45,026 per annum, including London Weighting Allowance. Grade 6|
|Placed On:||9th September 2021|
|Closes:||28th September 2021|
Building and Campus: Guy’s Tower, Guy’s Campus and Denmark Hill Campus
Contact: Heather Kneale, Heather.firstname.lastname@example.org
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 experienced Senior GMP Production Technician who has been working in a supervisory role in the Production department related to the development and manufacturing or testing and release of AAV (adeno-associated viral) 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 GMP production runs, ensuring the schedule is followed by participating in process development, validation and manufacturing processes, liaising with the quality and technical team, preparing of GMP compliant documentation, identifying bottlenecks and reporting to the Senior GMP Production Manager. In fulfilling these tasks, a strong background in GMP and interpersonal skills will be essential, but training (both in-house and through external courses) will be provided, as deemed necessary.
As part of the role profile, the Senior GMP Production 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 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 aseptic techniques and cell culture, process development and manufacturing. They will be competent in ensuring compliance to pharmaceutical quality system, interacting with quality assurance, compiling laboratory reports and product specification file, reviewing electronic batch manufacturing records for quality approval, batch certification and QP release. They will be competent working with supervising their team and interacting with: (i) Production staff performing upstream processing (thawing to crude bulk harvest), downstream processing (bulk purification to final vialed product), covering the different stages of product life cycle from vector design, plasmid specifications, process optimisation and development, validation, manufacturing of products for clinical trials.
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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