Technology Transfer Manager – Permanent – Shannon
We are currently looking for a Technology Transfer Manager to work onsite for a Clinical stage gene and therapy company, with a focus on developing potentially curative treatments for patients with serious diseases.
- Primary Liaison between Manufacturing Operation and Process Development functions to ensure smooth, accurate and timely transfer of knowledge in line with clinical/commercial supply requirements.
- Project Leadership/Management, scheduling and formal reporting of tech transfer and validation for each new product to establish manufacturing readiness for PPQ, Launch and subsequent lifecycle management.
- Responsible for Product Lifecycle Management activities, including Process Validation of processes in line with ICHQ8-10.
- Lead and/or provide techincal support using established problem-solving techniques for investigations into Quality Events. Provide technical recommendations, coordinate and execute CAPAs.
- Management of Change Controls; Providing impact assesments as a Technical Functional, coordinating input and support from development if required. Lead / Support and/or coordinate the action plans.
- Responsible for the development, review, and approval of production operation documentation (i.e., master Batch Manufacturing Records, Standard Operating Procedures, and Qualification protocols).
- Responsible for ensuring that own training and that of the team is undertaken in a timely and GMP compliant manner before the task is undertaken.
- Work cross functionally as a strong leader and establish effective partnerships with functional leads in MSAT/Development, Quality, Engineering, Manufacturing and Supply Chain.
- Act as a point of contact for Technical information in manufacturing with a clear understanding of the strengths of the developing SME network and how to access and use it.
- To work closely with the selected suppliers of raw materials and equipment during the development, tech transfer and implementation of new products, continuing through the lifecycle management of existing products.
- Responsible for ensuring that any GMP documentation, e.g. (but not limited to) Issues, CAPAs, Change Controls, BMRs & audit/inspection actions, within own area of responsibility, is closed timely and in an RFT state.
- Experience working with other departments.
- Project leadership/Management skills.
- Experience scheduling and formal reporting of tech transfers & validation.
- Experience with Product Lifecycle Management activities
- Experience leading and providing technical support, providing recommendations.
- Experience executing and coordinating CAPA’s.
- Experience Managing Change Control & Providing impact assessments.
- Experience with master Batch Manufacturing Records, Standard Operating Procedures, and Qualification protocols.
- Scientific Degree or equivalent, preferably with a higher qualification in bio-pharmaceutical sciences.
- Substantial experience with Biologics process development, MSAT or Manufacturing.
- Knowledge of cell biology, fermentation, scale-up and bioreactor operation, chromatography operation, Tangential Flow Filtration (TFF), and aseptic filling.
- Experience in supporting EHS programs. NEBOSH qualification or equivalent would be advantageous.
For further information or a confidential discussion please contact Liam Jones