An exciting opportunity has arisen for a Tech Transfer Sr.
Specialist at our Bio NX facility at Dunboyne.
The Technology Transfer Senior Specialist will be a member of the Tech Transfer Delivery team, reporting to the Technology Transfer Delivery Lead.
The successful candidate would be a responsible for supporting New Product Introduction, while also acting as a key contributor to the evolving site tech transfer strategy.
Key Activities Within Role: The Technology Transfer Specialist role will be a Change Champion within the organization and site, to bring about new products, digitization, and ways of working.
Primary Responsibilities: Collaborate with stakeholders to identify and execute the transfer requirements of programs.
This may include late stage clinical and/or PPQ (Process Performance Qualification) Lead tier meetings to coordinate activities between local and international groups for implementation of new Drug Substance manufacturing processes Support development of process descriptions, process models, facility fits, and other Tech Transfer-related documents for continuous and fed-batch processes Collaborate with stakeholders to deliver GMP documents related to TT, such as: Risk assessments, change controls, and process design documents Improve local Tech Transfer procedures to streamline and standardize New Program Introduction ways of working, while remaining compliant with the Quality Manual 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 Embody Safe by Choice know and follow the Safety, Health and Environment guidelines and work towards company safety and environmental goals Ensure the highest Quality, Compliance and Safety standards.
Required Education, Experience and Skills Minimum of 5 years of work experience in the pharmaceutical or biotech industry Bachelors degree in: Biotechnology, Engineering, Chemistry, or related field.
Experience with project management with cross-functional team members.
Familiarity with upstream and/or downstream Unit Operations for m Ab manufacturing Competent in analyzing complex situations and showing practical problem-solving capabilities Preferred Experience and Skills: Minimum of 3 years of experience with quality management and compliance systems.
Understanding of the general principles of New Product Introduction (Tech Transfer) Familiarity with the use of Automation systems in a manufacturing Process.
Competency in the use of automated/digital systems such as Delta V, MES, e Val Demonstrated experience in a GMP-regulated biological drug substance manufacturing environment, ideally with experience of single-use systems.
Validation experience including validation documentation generation and execution Familiarity with risk assessment processes Skills: PPQ Drug Substance manufacturing GMP Risk Assessment Change Control