We are currently looking for a Principal Analytical Scientist (Bioassay) to join a developing Gene Therapy company based in the London area. As the Principal Analytical Scientist (Bioassay) you will be responsible for the development and application of in vitro potency assays for gene therapy products, especially AAVs.
This is a great opportunity to further sharpen your leadership skills and be a direct line manager scientists within your team. Additionally you'll be a part of the CMC team and work collaboratively with the research and clinical teams as well as external collaborators ensuring the successful delivery of projects on the companies project line.
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the Principal Analytical Scientist (Bioassay) will be varied however the key duties and responsibilities are as follows:
1. You will apply your experience in development and application of in vitro potency assays for gene therapy products including infectivity, relative infectivity, expression and functional assays, enabling development and qualification.
2. Act as the Bioassay SME with project leadership duties to lead the development, training and trouble-shooting of bioassays, whilst gathering technologies applicable for AAV cell based assay development.
3. You will play a key role in keeping stakeholders informed with key findings, presentation at internal and external meetings, and represent the CMC department at these meetings.
4. Ensuring raw data is processed accordingly and designing experimental plans, documentation and experimental writeups, and support writing and review of experimental analytical protocols and lab procedures.
To be successful in your application to this exciting opportunity as the Principal Analytical Scientist (Bioassay) we are looking to identify the following on your profile and past history:
1. Relevant degree in Biological sciences or a similarly related qualification. A PhD is desirable.
2. Proven industry experience in working in a GMP environment and understanding ICH guidance for ATMP product release. Experience in gene therapy processing technologies, analytical bioprocessing is desirable.
3. A working knowledge and practical experience with cell culture of multiple mammalian lines, track record of method development and troubleshooting in analytical assays, and technology transfer to/from commercial and research organisations.
Key Words: Gene Therapy | AAV | Cell Line | ATMP | DSL | Bioassay | Bioprocessing | ICH | GMP | Tech Transfer | Technology Transfer | Project Management | Analytical Assays | PhD | London | CMC | In Vitro |
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.