GMP Production Scientist

Job description 

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.

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.

Skills, knowledge, and experience

Essential criteria

Qualifications and Training

• Level 6 qualification, e.g. relevant undergraduate degree or equivalent, in Biological and/or Engineering discipline related to life sciences plus substantial work experience in relevant technical/ scientific service post or extensive work experience in relevant technical/ scientific post with management experience and/ or qualification (AP, I).
• Comprehensive background in analytical methods development, hands-on experience in aseptic handling, cellular and bioprocessing techniques, analytical methods optimisation and development and process validation (AP, I). 
• Knowledge and experience of GMP standards in developing analytical methods for manufacture of viral gene therapy products as IMPs/INDs for clinical trials for pre-clinical and clinical trials in an academic organisation or industry (I). 

Skills / Experience

• Comprehensive knowledge of wide range of analytical technics and scientific practice and the theory underpinning these technologies (I).
• Comprehensive knowledge of regulations and best practice (including Health & Safety and environmental sustainability) governing operations in a licensed GMP facility in addition to approved manufacturing procedures for use in GMP manufacturing and product release (I).
• Experience and knowledge of working within a Pharmaceutical Quality System (PQS) ensuring document control, training records, change control, investigations, CAPA, OOS, quality risk management, supplier qualification and approval, etc are in compliance with PQS (I).  
• Excellent planning and organisational skills to manage own tasks and supporting the tasks of team members. Excellent leadership skills to lead a team and set performance standards, monitoring the tasks and outputs to ensure successful delivery (I). 

Knowledge

• Comprehensive 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 (I). 

Please see website for full Job description.

Closing date: 2^nd April 2024

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