Technical Manager

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.

Responsibilities

• 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. 

Key Requirements

• 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.

Qualifications
 

• 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 

061 363318 

liamjones@cregg.ie