Downstream Tech Transfer Specialist
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Hobson Prior are currently looking for a Downstream Tech Transfer Specialist to join a brilliant biotech organisation on a permanent basis located in London. Our client is focused on developing solutions that might have the possibility of curing those who suffer from serious illnesses.
Please note that to be considered for this role you must have the right to work in this location.
- For this role, you will be accountable for guaranteeing that own work is assumed in a GMP compliant and timely manner before the task is assumed.
- Responsible for management of change controls.
- Guide and/or offer technical aid using formed issue resolving practices for investigations into quality events, customer complaints and IMC actions.
- Offer technical suggestions, arrange and implement CAPAs.
- Accountable for guaranteeing that any GMP documentation allocated to them which might include Issues, CAPAs, Change Controls, BMRs & audit/inspection actions are closed in a RFT state and timely manner.
- The ideal candidate will develop technical SME in the technical support team and broader manufacturing operations.
- You will be responsible for project management and formal reporting of tech transfer and validation for each new product to form manufacturing promptness for PPQ, launch and subsequent lifecycle management aligned with ICHQ8-10.
- Offer impactful assessments as a technical functional, arranging contributions and assistance from development if necessary.
- Guid/assist and/or arrange the actions plans.
- Accountable for guaranteeing that own work complies with GMP, data integrity and GDP and is assumed rendering to suitable processes.
- Educated to a degree level in a scientific field with a higher qualification in a field linked to biopharmaceutical sciences would be ideal.
- Familiarity with downstream processing, with acquaintance to AKTA Ready systems and Unicorn software would be ideal.
- Prior involvement with transferring pharmaceutical products from development into a GMP manufacturing setting, gaining approval and launching new products commercially.
- Interpersonal capabilities with the ability to collaborate with others cross-functionally with partners both internally and externally.
- Know-how of regulatory compliance needs in Europe and the US.
- Acquaintance with management of root cause analysis investigations utilising lean/six sigma tools.
- Capable of handling various cross-functional projects simultaneously to deliver against key project milestones and deadlines.
- Familiarity with handling workload of small teams to meet deadlines.
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.
€55000 - €65000 per annum
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