Director of Quality Control

Director of Quality Control – Start Up Biotech Company – London – Permanent

Our growing Biopharmaceutical client who are seeking to deliver truly innovative, life-changing therapies for their patients are looking for someone to fill the role of Quality Control Director. Their vision as a company is to be a major global biopharmaceutical player bringing transformational and valued therapies for a range of autoimmune and inflammatory diseases.

This Director level role will be accountable for the development of analytical methods to support process development and enable QC release testing of the client’s products and will be responsible for leading, developing and growing the Analytical Group.

Key Responsibilities:

• Leadership of the analytical group with responsibility for the development of an analytical platform to support process/product development and provide initial QC release testing of clinical trial material across our client’s product portfolio
• Development of relevant technology platform solutions (e.g. PAT) in partnership with third parties
• Development and execution of a sound strategy to develop and grow the analytical group in line with the company’s business plan
• Close collaboration with other teams to ensure process development and manufacturing strategies, targets and ways of working are fully aligned
• Visible and credible external engagement (incl. academic groups, CMOs etc.) to support company deliverables
• Oversee and manage the release testing of vectors and plasmids through close collaboration with our CMOs
• Technical leadership and input to the regulatory strategy regarding analytical method development and QC release
• Technical review of regulatory documentation (INDs, IMPDs etc.) and participation in engagement with regulatory bodies such as the EMEA and FDA.

We are looking for:

• A talented and highly motivated individual with significant analytical development and/or QC experience in cell & gene therapy.
• Someone that has a solid understanding of the cross-functional CMC requirements to develop and manufacture new cell & gene therapy products as well as demonstrated innovative thinking and milestone delivery in this space.
• Director/Associate Director level.

If you would like to find out more about this or any other roles, please apply now for immediate consideration.



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