Downstream Process Tech Transfer Lead
- Interim/Contract
- Technical Operations, Engineering, Process Engineer
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Hobson Prior are working with a world-wide biopharmaceutical organisation whose pioneering medicines are used by millions of patients all over the world. Our client is looking for a Downstream Process Tech Transfer Lead to join them on a contract basis.
Please note that to be considered for this role you must have the right to work in this location.
Key Responsibilities:
- Routinely transfer projects as downstream tech transfer representative including fit-to-plant, process risk analysis, timely generation of TT documentation, batch record review/approval, managing technical relationship between sending and receiving organizations, campaign monitoring and support, performance analysis and interpretation, investigation support, and campaign summary report authoring.
- Manage lab-scale experiments to support process changes, generate robustness data, and/or resolve manufacturing non-conformances.
- Proactively influence process decisions to help avoid non-conformances.
- Provide input on process development and manufacturing strategies.
- Author/review technical reports and deliver presentations utilizing sound scientific reasoning and interpretation of the available data.
- Author/review IND/BLA sections and responses to questions to support regulatory filings.
- Builds and maintains relationships with partners, collaborators, departments and contractors.
- Contribute to the improvement of the TT business processes through idea generation, team leadership, and implementation.
Requirements:
- Knowledge of CMC activities and responsibilities with respect to TT.
- Have people manager experience in matrix team environments, to be able to work with numerous subject matter experts and drive successful completion of team goals.
- Excellent knowledge of chromatography columns, virus and sterilizing-grade filters, and TFF membranes.
- Essential understanding of downstream unit operations such as affinity, ion exchange, and hydrophobic interaction chromatography, low pH and surfactant-based viral inactivation, virus filtration, and UF/DF.
- Excellent knowledge of GMP manufacturing principles and documentation.
- Have critical thinking skills.
- Have excellent knowledge of scale-up/scale-down principles.
- Excellent written and verbal communication skills.
- Have the ability to outline issues, assess and present risks, and ability to make recommendations with limited data using sound scientific reasoning.
- Expert in effectively explaining complex scientific or engineering concepts to a broad.
Apply now:
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.
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