Tech Transfer Specialist Drug Product
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Hobson Prior are currently seeking a Tech Transfer Specialist Drug Product to join a gene therapy organisation who are determined to develop possible curative treatments for patients who are living with serious illnesses. This role will be the technical lead for transfer and scale-up of Drug Product/Fill & Finish operations in new facility during design/construction phase.
- You will be responsible to develop technical subject matter expertise in the technical support team and broader manufacturing operations.
- To provide 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 be accountable for product lifecycle management activities including process validation of processes in line with ICHQ8-10.
- You will be responsible to lead and/or provide technical support using established problem-solving techniques for investigations into quality events, customer complaints and IMC actions.
- To 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.
- Shows confidence in self and others; inspires and motivates others to perform well.
- Gets involved in strategic decision-making within the business as an influencer.
- Recognises and resolves problems in a timely manner.
- Develops workable implementation plans; communicates changes effectively; builds commitment and overcomes resistance; prepares and supports those affected by change; monitors transition and evaluates results.
- Works within approved budget; develops and implements cost saving measures; contributes to profits and revenue; conserves organizational resources.
- 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.
- Excellent verbal and written communication skills, in English.
- 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.