We are currently looking for a Associate Director Analytical Development - Gene Therapy to join a leading Biologics company based in the North West of the UK. As the Associate Director Analytical Development - Gene Therapy you will the internal Technical Expert for Cellular and Molecular Analytical methods for the assessment of Biological products, specifically Gene Therapy and Vaccine therapeutics.
You will work cross functional with Analytical Development, Process Development and CMC teams as well as with external collaborators and clients to ensure the successful development of novel Therapeutics.
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the Associate Director Analytical Development - Gene Therapy will be varied however the key duties and responsibilities are as follows:
1. Responsible for defining strategy for CMC analytics to support product and process development with a focus on designing Biological Characterisation plans to ensure processes meet internal and external guidelines including ICH regulatory guidelines,
2. Act as Technical lead and Subject Matter Expert for the development, optimisation and transfer of routine and non-routine methods including but not limited to PCR, ddPCR, ELISA, Cell-based Assays (for viral analysis) and sequencing methods including Sanger and NGS.
3. Review technical data and troubleshoot accordingly to support Method Development and Validation activities.
4. Prepare, review and approve analytical biological characterisation data to support regulatory filings and address subsequent regulatory questions.
To be successful in your application to this exciting opportunity as the Associate Director Analytical Development - Gene Therapy we are looking to identify the following on your profile and past history:
1. Relevant degree in a Biologics Life Sciences discipline. PhD is preferred but not required as well as relevant industry experience in a Biologics industry, ideally with a focus on Viral and Gene Therapies.
2. Proven industry experience in the Characterisation of Biological products where you are a technical expert in one of more of the following techniques: PCR, ddPCR, ELISA, Sanger Sequencing, Next Generation Sequencing (NGS), Cell based and Bioassys for viral protein analysis.
3. A working knowledge and practical experience with technical and regulatory strategy for CMC and Characterisation. Experience of ATMPs and Regulatory Agency interactions would be beneficial.
Key Words: Associate Director | Analytical Development | Method Development and Validation | Characterisation | Process Development | CMC | Biopharmaceutical | Biologics | Viral Vectors | Gene Therapy | Vaccines | Viruses | AAV | Retrovirus |
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
Enzyme Linked Immunosorbent Assay (Elisa)
Polymerase Chain Reaction