Ref. 01278
Senior Technical Transfer Specialist
An exciting opportunity has arisen with our client, a leading Pharmaceutical company located in Dunboyne, Co. Meath, for a Technical Transfer Senior Specialist.
Reporting to the Technology Transfer Delivery Lead, in this role you will be a member of the Tech Transfer Delivery team, responsible for supporting New Product Introduction, while also acting as a key contributor to the evolving site tech transfer strategy.
Key Activities within the role:
The Technology Transfer Specialist role will promote change within the organization and site, to bring about new products, digitization, and ways of working.
Primary Responsibilities:
1. Collaborate with stakeholders to identify and execute the transfer requirements of programs. This may include late stage clinical and/or PPQ (Process Performance Qualification).
2. Lead tier meetings to coordinate activities between local and international groups for implementation of new Drug Substance manufacturing processes.
3. Collaborate with stakeholders to deliver GMP documents related to TT, such as: Risk assessments, change controls, and process design documents.
4. Support development of process descriptions, process models, facility fits, and other Tech Transfer-related documents for continuous and fed-batch processes.
5. Improve local Tech Transfer procedures to streamline and standardize New Program Introduction ways of working, while remaining compliant with the Quality Manual.
6. Embody Safe by Choice – know and follow the Safety, Health and Environment guidelines and work towards company safety and environmental goals.
7. Assist in the development of future breakthrough business solutions, to reduce overall effort / reduce risk, to progress the team forward to “one-click” tech transfer.
8. Ensure the highest Quality, Compliance and Safety standards.
Requirements:
1. 5+ years’ work experience in the Pharmaceutical or Biotech industry.
2. Bachelor’s degree in Biotechnology, Chemistry, Engineering or related field.
3. Experience with project management with cross-functional team members.
4. Competent in analyzing complex situations and showing practical problem-solving capabilities.
5. Familiarity with upstream and/or downstream Unit Operations for mAb manufacturing.
Desirable:
1. 3+ years of experience with quality management and compliance systems.
2. Understanding of the general principles of NPI (Tech Transfer).
3. Familiarity with Automation systems in a manufacturing Process.
4. Validation experience including validation documentation generation and execution.
5. Familiarity with risk assessment processes.
6. Competency in the use of automated/digital systems such as DeltaV, MES, eVal.
7. Demonstrated experience in a GMP-regulated biological drug substance manufacturing environment, ideally with experience of single-use systems.
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