Director of Analytical Development (AD)

Walker Cole International is searching for a Director of Analytical Development (AD) to join a Cell & Gene Therapy company based in London. As the Director of Analytical Development (AD), you will lead the development and implementation of Cellular and Molecular Analytical methods for the assessment of an innovative AAV based therapeutic.

Your responsibilities will be:

• Define a CMC analytics strategy to support product and process development with a focus on designing Biological Characterisation plans that meet internal and external guidelines including ICH(Q2) regulatory guidelines.
• Prepare, review and approve analytical biological characterisation data to support regulatory filings and address subsequent regulatory questions.
• Design an effective strategy for technology transfer of analytical methods to QC teams to support GMP manufacturing, including supporting Method Development and Validation activities.
• Introduce novel technologies/improve existing analytical methods/techniques.
• Form an integral part of the Senior Leadership Team defining company culture, strategy and objectives.

The successful candidate will possess:

• MSc/PhD in science related disciplines
• Significant experience with the characterisation of biological products, with technical expertise 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.
• A proven track record in achieving commercialisation of Biopharmaceutical Products.
• Experience with regulatory filings (IND,IMPD,BLA,MAA).
• Subject Matter Expertise with AAV technologies or other Cell and Gene Therapies would be highly advantageous.