Senior Technical Transfer Specialist

ref. 01278

Senior Technical Transfer Specialist

An exciting opportunity has arisen with our client, a leading Pharmaceutical company based 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:
• 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
• Collaborate with stakeholders to deliver GMP documents related to TT, such as: Risk assessments, change controls, and process design documents
• Support development of process descriptions, process models, facility fits, and other Tech Transfer-related documents for continuous and fed-batch processes
• Improve local Tech Transfer procedures to streamline and standardize New Program Introduction ways of working, while remaining compliant with the Quality Manual
• Embody Safe by Choice – know and follow the Safety, Health and Environment guidelines and work towards company safety and environmental goals
• 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
• Ensure the highest Quality, Compliance and Safety standards.

Requirements
• 5+ years’ work experience in the Pharmaceutical or Biotech industry
• Bachelor’s degree in Biotechnology, Chemistry, Engineering or related field.
• Experience with project management with cross-functional team members.
• Competent in analyzing complex situations and showing practical problem-solving capabilities
• Familiarity with upstream and/or downstream Unit Operations for mAb manufacturing

Desirable
• 3+ years of experience with quality management and compliance systems.
• Understanding of the general principles of NPI (Tech Transfer)
• Familiarity with Automation systems in a manufacturing Process.
• Validation experience including validation documentation generation and execution
• Familiarity with risk assessment processes
• Competency in the use of automated/digital systems such as DeltaV, MES, eVal
• Demonstrated experience in a GMP-regulated biological drug substance manufacturing environment, ideally with experience of single-use systems.