Tech Transfer Specialist - Drug Product
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Hobson Prior are currently working with a gene therapy organisation who are determined to develop possible curative treatments for patients who are living with serious illnesses. Our client is looking for a Tech Transfer Specialist - Drug Product to join them on a permanent basis in London. You will have the opportunity to establish and develop the processes required to carry out Technical Transfer of new products.
- Accountable to develop technical subject matter expertise in the technical support team and wider manufacturing operations.
- Accountable for product lifecycle management activities including process validation of processes in line with ICHQ8-10.
- Project leadership/management and formal reporting of tech transfer and validation for each new product to establish manufacturing readiness for PPQ, launch and subsequent lifecycle management.
- You will lead and/or provide technical support using established problem-solving techniques for investigations into quality events, customer complaints and IMC actions.
- You will provide technical recommendations, co-ordinate and execute CAPA's.
- To manage change controls; providing impact assessments as a technical functional, coordinating input and support from development if required. Lead/support and/or coordinate the action plans.
- Any other assigned duties.
- Demonstrated interpersonal skills with ability to work cross-functionally both with internal and external partners.
- Excellent verbal and written communication skills, in English.
- Ability to present effectively to groups.
- Excellent communication skill and influencing skills and the ability to establish effective working relationships with personnel at all levels.
- Ability to manage, multiple, cross functional projects to deliver against key project milestones and deadlines.
- Scientific Degree or equivalent, preferably with a higher qualification in a discipline related to bio-pharmaceutical sciences.
- Extensive Fill & Finish experience in a commercial Pharma/Bio environment, ideally with exposure to automated visual inspection.
- Experience of transferring pharmaceutical products from Development into a GMP manufacturing environment, successfully gaining approval and launching new products commercially.
- Knowledge of Regulatory compliance requirements within Europe and the USA.
- Demonstrated experience in the management of root cause analysis investigations utilising Lean/Six Sigma tools.
- Experience of managing workload of small teams to meet deadlines.
- Thorough working knowledge of ICH guidelines and current Good Manufacturing Practices.
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.
£40000 - £50000 per annum
Manchester, Greater Manchester
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