Senior Production Scientist
The Cell and Gene Therapy, King's (CGT-K), group manufactures a variety of Advanced Therapy Medicinal Products (ATMPs) in state of the art Good Manufacturing Practice (GMP) facilities for novel therapies of different cancers and rare diseases.
As a qualified GMP operator the post holder will be in a supervisory position in the CGT-K production team, manufacturing different types of Investigation Medicinal Products (IMPs) and “Specials” for cell therapies, but especially viral vectors for clinical trials. The work will include the day-to-day management of GMP production runs, ensuring the schedule is followed by participating in manufacturing processes, liaising with the quality and technical team, preparing GMP compliant documentation, identifying roadblocks and reporting to the Head of Production / Production Manager. In fulfilling these tasks, a strong background in GMP and interpersonal skills will be essential.
Senior Production Scientists lead production campaigns which would include managing the involved staff and addressing any issues in a GMP compliant way. S/he is responsible for organising and prioritising his/her workload and resources as well as making independent decisions related to a production run. Based on his/her experience Senior Production Scientists implement new procedures and changes under consideration of GMP compliance.
Senior Production Scientists make sure, on a daily basis, that production activities s/he is in charge of are carried out as scheduled to agreed time and quality standards. As part of a production team s/he organises and delegates work in manufacturing runs, give general guidance and training to other members of the team. In consultation with the Production Manager / Head of Production Senior Production Scientists identify and address training needs of team members, motivate the team and set an example for team members.
Senior Production Scientists work mainly in cleanrooms performing GMP productions. S/he must also be able to adapt quickly to work in an office environment dealing with the compliance-related documentation of the manufacture activities such as Manufacturing Records, Standard Operating Procedures, risk assessments, validation protocols and deviation reports. All tasks need to be performed consistently with a high level of concentration, including safe handling of different types of equipment, following of corresponding safety procedures, and in compliance with various regulatory requirements.
Senior Production Scientists need to possess a broad knowledge of and experience in GMP activities. S/he need to be familiar with the relevant processes and systems in compliance with regulatory requirements and with quality standards.
Senior Production Scientists are required to perform to the highest standards as a GMP operator and to acquire progressively more demanding skills, knowledge and experience of GMP compliant manufacture of ATMPs including cell and gene-based therapies.
This post will be offered on an indefinite contract.
This is a full-time post.
- Leading GMP production campaigns for different types of products
- Writing and completing production documents (e.g. manufacturing records, SOPs, CAPAs)
- Performing manufacture of viral vectors, IMPs and “Specials” under GMP in multiple cleanroom facilities
- Training of staff
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.
Skills, knowledge, and experience
1. Experienced GMP operator
2. First degree in Biological Sciences
3. Knowledge of GMP regulations
4. Knowledge and experience in working aseptically in cleanrooms
5. Knowledge and experience in cell culture
6. Experienced in writing of GMP-compliant documents (e.g. Manufacturing Records, Standard Operating Procedures, CAPAs)
7. Able to work independently, but also as part of a team
9. Detail orientated
1. Knowledge and experience in viral vector manufacture
2. Experienced in managing projects / small teams
3. Experienced in process development