GMP Production Scientist

Job id: 085606. Salary: £37,332 - £42,099 per annum, including London Weighting Allowance.

Posted: 08 March 2024. Closing date: 02 April 2024.

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

Contact details:Heather Kneale. [email protected]

Location: Guy's and Denmark Hill Campuses. Category: Professional & Support Services.

Role purpose

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.

This role is for a qualified and trained GMP Production  Scientist who has been working in the Production department related to 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.

Role profile

As part of the role profile, the GMP Production  Scientist 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.

The postholder 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. They 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. They will be trained in performing assigned duties within a team and interacting 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 for 14 months in the first instance.

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

Key Objectives:

In the Centre for Cell & Gene Therapy at Guy’s and Denmark Hill campus

• Perform operations related to manufacturing as an active member of CCGT working on the development and release of cell and gene-based therapies.
• Develop and execute manufacturing procedures for implementation and approval for cGMP compliance 
• Demonstrate a commitment to ongoing professional development, complete own periodic staff qualification and training records related to manufacturing procedures. Engage in and undergo relevant training, including hands-on GMP operations related to qualification, aseptic techniques, cell culture, viral product harvest, purification, formulation and final product filling. Manage training of staff in accordance with approved Training Matrix and as required for GMP compliance. Continually update knowledge and understanding in the field of cell and gene therapy.
• Perform assigned tasks in the execution of site start-up activities related to facility and equipment qualification, qualification procedures, environmental monitoring and decontamination operations, process development and validation activities, technology transfer for manufacturing procedures and scale-up of manufacturing and purification processes.
• Pro-actively support the quality team in the development and execution of electronic quality assurance operations related to Pharmaceutical Quality System compliance, electronic design history records, electronic batch records and electronic supplier management system
• Actively support team responsible for ensuring compliance of clean room preparation and quarantine procedures prior to and after GMP manufacturing.
• Support team in the use of validated manufacturing or analytical equipment, providing training where required.
• Assist and support other members of the group, using a systematic and timely approach to solve problems, while handling multiple projects to ensure continued GMP manufacturing and release of gene therapy products.
• Provide cover the absence of key production staff.
• Manage own workload and resources based on an agreed work plan for achievement of project aims whilst also being responsive to changing priorities.
• Use well-developed analytical skills to identify trends and patterns, using appropriate techniques and procedures to inform decisions and ensure product quality, patient safety and GMP compliance. Ensure work complies with PQS and set high quality standards for service and execution.
• Complete and submit up-to-date, accurate and comprehensive documentation records and laboratory reports, where applicable.
• Communicate complex information in a clear and precise way, both orally and in writing. Prepare and submit laboratory reports. Generate and provide data/results for a variety of tasks including presentations at regular GMP lab meetings, seminars, manuscripts, national or international meetings and to support improvement in analytical validation and testing.
• Attend and contribute to team meetings for periodic review and progress
• Actively contribute to decisions affecting performance and in meeting objectives of the team.
• Complete assigned tasks in collaboration with other departments involving key stakeholders in Process Development
• Forge relationships with colleagues in the university and externally, to build relationships, disseminate and get information, coordinate, and deliver the service
• Provide advice/ guidance and, where appropriate, training. For new staff in the conduct of individual and collaborative research projects.
• Demonstrate leadership and innovation in the implementation of environmentally sustainable practices, recording progress through the King’s sustainability audit process and sharing good practice. Nurture and encourage sustainable practices and leadership within your team and networks. 
• Facilitate an inclusive culture and ethos working with academic, research and other professional services staff and colleagues external to King’s. 

The above list of responsibilities may not be exhaustive, and the post holder will be required to undertake such tasks and responsibilities as may reasonably be expected within the scope and grading of the post.

A more comprehensive overview of the key responsibilities may be requested from Heather Kneale –[email protected]. 

Essential criteria

Qualifications and Training

Skills / Experience

Knowledge

Competencies

Desirable criteria