Technology Transfer Specialist

Duration: 12 months

The Technology Transfer specialist will be a member of the Manufacturing Operations team, reporting to the Technology Transfer Lead. The successful candidate would be responsible for supporting New Product Introduction, while also acting as a key contributor to the evolving site tech transfer strategy.

They will be a Change Champion within the organisation and site, to bring about new products, digitisation, and ways of working

• Support for developing Tech transfer program.
• Collaborate with the team and stakeholders to deliver GMP documents related to TT, such as Risk assessments, change controls, batch records, sampling plans, Bills of Material.
• Maintain and feed information delivered from Development in different digital tools such as COMET SAP, MES, and Delta
  
  V.
• Manage new programs introduction schedule to ensure tasks are executed on schedule
• Contribute/support in various teams as Tech Transfer representative.
• Manages small projects with moderate resource requirements, risk and/or complexity.
• Support development of process descriptions, process models, facility fits, and other Tech Transfer-related documents for continuous and fed-batch processes.
• Supports the design and implementation of best practices in tech transfer
• Assist in the development of future breakthrough business solutions to reduce overall effort/risk, optimising for rapid product launch, to progress the team forward to “one-click” tech transfer.
• Writing, maintaining of BOM's (Bill of material) and E ’s (Paper), gBMR (MES) and SOPs/WI’s.
• Support to aggregate process related knowledge and centralize for knowledge management.
• Ensure the highest Quality, compliance, and Safety standards.

• Degree qualification in a relevant field (Science/Technical)
• Minimum of 5 years of work experience in the pharmaceutical or biotech industry
• Familiarity with Unit Operations for mAb manufacturing. Experience in a GMP-regulated biological drug substance manufacturing environment, ideally with experience of single-use systems, is preferred
• Competent in issuing and transcribing information into documents required for manufacturing, such as BOM, Batch Sheets and DeltaV
• Competency in the use of automated/digital systems such as DeltaV, MES, eVal, SAP COMET
• Has managed a small project with a cross-functional group
• Working knowledge of cGMP regulations and understanding of the general principles of New Product Introduction (Tech Transfer)
• Professional English proficiency is required. Good knowledge of German is an asset.
• Competency in analysing complex situations and showing practical problem-solving capabilities
• Ability to work effectively as part of a team and independently.
• Demonstrate a desire for continuous learning, improvement, and development, while approaching problems from new perspectives