CMC/Tech Transfer Lead - ATMPs

Posted 5 days ago by Hays Specialist Recruitment Limited
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Biotech, T-cell, biology, science, research, drug, protein, cell, GMP, Process development, job, CMC, atmp

The Company

My client is an upcoming and rapidly expanding Biotech with who are looking to develop the latest generation of advanced T cell-based therapeutics aimed at Immuno-Oncology targets. They have broad portfolio, with several candidates in Phase I/II clinical trials

The Role

They are looking for an experienced candidate to lead and manage all tech transfer activities for the manufacture of T-Cell based therapeutics for use in Phase I/II clinical trials. You will be liaising between process development and both external and internal manufacturing teams, creating and manage translational project plans and coordinate activities between process development and manufacturing.

The Candidate

  • PhD in biological sciences, engineering or related field or minimum of several years progressive experience in a cell therapy CMC development or with technology transfer for clinical-phase assets
  • Knowledge of GMP, MHRA and FDA requirements for ATMP
  • Ability to use Quality by Design tools to support process validation
  • Experience with leadership of T cell therapy manufacturing activities and site-to-site tech transfer
  • At least 3 years' experience in project management or equivalent experience in a technical leadership role
  • Experience working in a cross-functional CMC team on an immunotherapy, biopharmaceutical or gene therapy
  • Understanding of the drug development process from development through to market
  • Demonstrable experience of managing projects and maintaining project documentation
  • Demonstrable matrix leadership or line management experience and skills
  • Experience of drafting technical content for regulatory documents

The Benefits

This would be a senior role, based in Stevenage, looking to pay competitive salary (~£60-70,000) for the right candidate, with an extensive benefits package (bonus, stock, health insurance etc…). If you think you match the skills listed above and are looking for a new challenge in the Biotech industry, then please apply with your CV or call William Ashbrook on for a completely confidential chat about your situation.

Reference: 40880467

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