GMP Production Scientist

About the role

This role is for a qualified and trained GMP Production Scientist who has been working with 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.

About you

To be successful in this role, we are looking for candidates to have the following skills and experience:

Essential criteria

1. Minimum level 6 qualification, e.g. relevant undergraduate degree or equivalent OR considerable knowledge and skills gained through work experience, with GMP training and ATMP manufacturing experience for the release of viral gene therapy products as IMPs/INDs for clinical trials
2. 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
3. Background in bioprocess engineering, and hands-on experience in aseptic handling, cellular and bioprocessing techniques, and trained as Production Technician or Scientist for GMP manufacturing, leading to release of gene/cell therapy IMPs/ MS products in a licensed GMP facility in university or industry. Trained in bioprocess optimisation and development, process validation, GMP manufacturing of MCB/WCB, gene/cell therapy products for pre-clinical and clinical trials in a reputed academic organisation or industry, with a commitment to ongoing professional development
4. Experience in Production related operations in a licensed GMP facility with a good knowledge of regulations and best practice governing cGMP compliance including qualification of staff, cleanroom and equipment, in addition to approved manufacturing procedures for use in GMP manufacturing and product release
5. Experience in working with quality team ensuring document control, training records, validation including calibration and maintenance, audit, change control, deviations, CAPA, OOS, quality risk management, supplier qualification and approval, etc are in compliance with PQS
6. Working knowledge of EudraLex - Volume 4 - Good Manufacturing Practice (GMP) guidelines, current MHRA Orange Guide including EU GMP regulations for ATMP manufacturing for clinical trials
7. Awareness or knowledge in compiling Site Validation Master Plan covering aspects of site/equipment validation, calibration and maintenance requirements, Process Validation Master Plan covering aspects of process validation and transfer to GMP Batch Manufacturing Record for QP review and release
8. Trained in relevant aseptic, cellular and bioprocess techniques for development, validation and manufacturing of gene therapy vectors. Experience in (i) aseptic techniques related to cell culture, product harvest, product purification, formulation and final product filling in a GMP facility, (ii) preparation for internal, external and regulatory audits, executing operations leading to GMP inspection readiness and approval
9. Clear spoken and written communication skills and strong interpersonal skills
10. Competent in completing and handling electronic or paper-based quality/batch documentation and records for IMPs/MS products

Closing date: 23^rd June 2024

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