Biotech, T-cell, biology, science, research, drug, protein, cell, GMP, Process development, job, CMC, atmp
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
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.
- 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
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.
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