Tech Transfer Lead
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Hobson Prior are currently in search for a Tech Transfer Lead to join a fast-paced biopharmaceutical organisation who are creating ground-breaking products that have never been made before. This is an excellent opportunity to work in a flexible and dynamic working environment that fosters creativity, leadership and teamwork.
Please note that to be considered for this role you must have the right to work in this location.
- Provide technical review of data for scientific evaluation and presentation material for internal stakeholder meetings.
- Working closely with the bioprocessing and manufacturing technology team, you will shape the tech transfer of new equipment and devices to drive continuous improvements of the organisation's manufacturing process.
- Partner with Process Development groups to support, as needed, scale up and address technical challenges ready for GMP including assessment of raw materials.
- To ensure tech transfer activities are aligned with CMC and corporate milestones and timelines.
- You will operate at a cross functional level interfacing with the organisation's department and function leads as well as working closely with the operational and technical teams as required.
- Support the development of a technology transfer strategy that is in-line with the overall regulatory and GMP strategy and the clinical development plan.
- Responsible for leading the technology transfer of new manufacturing processes, manufacturing technology and analytical assays into the organisation's GMP sites.
- To work with the key leaders in the GMP function for both early, late stage and commercial manufacturing to deliver effective technology transfer of new technology.
- Coordinates with function team leads and create logical workflows, and drive continuous improvement of technology transfer, identifying areas for development to ensure protocols, and procedures are GMP ready.
- Provide guidance and support to the GMP team for trouble shooting on clinical and commercial manufacturing and QC issues during tech transfer and validation.
- Commit to safety and risk planning to ensure workplace safety and security is maintained to the highest level.
- Experience in project management of process tech transfer or equivalent experience in a technical leadership role in cell and gene therapy at clinical stage.
- Previous experience of the regulatory and GMP framework for advanced therapies.
- Experience working in a cross-functional CMC team in the field of advanced therapies.
- Experience in analytical development specifically flow cytometry, ELISA and ELISPOT.
- Strong knowledge of analytical method lifecycle.
- Understanding of the GMP QA requirements for introducing process and assay changes.
- Experience of drafting CMC technical content for regulatory submissions.
- Demonstrable experience of qualification and validation for process and analytical methods.
- Demonstrable understanding on the process and regulatory requirements for the qualification of raw materials for GMP.
If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.