We are currently looking for a Cell Therapy MSAT Senior Scientist to join a leading Cell Therapy company based in the Cambridgeshire area. As the Cell Therapy MSAT Senior Scientist you will be responsible for managing late-stage technical operations to support business objectives for clinical cell therapies.
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the Cell Therapy MSAT Senior Scientist will be varied however the key duties and responsibilities are as follows:
1. You will collaborate with technical partners, establish reliable cGMP-compliant networks of to tech-transfer process information to CDMOs, and develop manufacturing processes across the clinical cell therapy portfolio.
2. You will use your knowledge of cell therapy products and ATMPs to uphold regulatory inspections, and assist in the preparation of CMC regulatory documents.
3. You will coach, mentor, and train direct and in-direct reports to ensure a high-performing technical operations team.
4. As the Cell Therapy MSAT - Senior Scientist you will design experiments quickly to drive analytical processes, and prevent and resolve technical operations issues (deviations, CAPAs, delays)
To be successful in your application to this exciting opportunity as the Cell Therapy MSAT - Senior Scientist we are looking to identify the following on your profile and past history:
1. Relevant life sciences degree in Cell Biology, Stem Cell Biology, Molecular Biology, Biological Sciences. A PhD in advantageous.
2. Proven industry experience in a the scale up and delivery of GMP produced cell therapies.
3. A working knowledge and practical experience with management of clinical products with internal facilities and contract manufacturers, and a deep understanding of regulatory requirements (FDA, HA, ICH Guidelines)
Key Words: Cell Therapy | Cell Therapies | Stem Cell | T Cell | GMP | ATMP | Gene Therapy | Cell and Gene Therapy | Biotechnology | Manufacturing | Upstream | MSAT | Upstream Process | Process Development | CMC | Technical Operations | Tech Transfer | Technology Transfer | Project Management | CAPAs | Bioprocessing | Good Manufacturing Practice | cGMP | Change Control | Biotech | Management | FDA | Regulatory
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for talent development. We therefore welcome applications for any interested parties who fulfil the role requirements for this position. HRS is a company exclusively supporting the science and technology sectors, and is made up of a collaboration of recruitment professionals and scientists. We look forward to helping you with your next career moves.