Tasks

• Support of 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 DeltaV.
• Manage new program introduction schedule to ensure tasks are executed on schedule and right-first time.
• 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 design and implementation of best practices in tech transfer
• Assist in the development of future breakthrough business solutions, to reduce overall effort / reduce risk, optimizing these to make way for rapid product launch, to progress the team forward to "one-click” tech transfer.
• Provide feedback and propose opportunities for optimization to current Tech Transfer processes to incorporate lessons learned.
• Writing, maintaining of BOM's (Bill of material) and EBR’s (Paper), gBMR (MES) and SOPs/WI’s.
• Demonstrate excellent troubleshooting and problem-solving skills, as well as the ability to collaborate and work effectively within global and interdisciplinary teams.
• Demonstrate a desire for continuous learning, improvement, and development, while approaching problems from new perspectives.
• Support to aggregate process related knowledge and centralize for knowledge management.

Qualification:

• A 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
• Project management basic knowledge
• 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 regulation
• Understanding of the general principles of New Product Introduction (Tech Transfer)
• Oral / written communication skills in English (B1) would be must and German would be desirable
• Demonstrated experience in a GMP-regulated biological drug substance manufacturing environment, ideally with experience of single-use systems.
• Competent in analyzing complex situations and showing practical problem solving capabilities
• Familiarity with risk assessment processes
• Competent in analyzing complex situations and showing practical problem-solving capabilities
• Familiarity with the use of Automation systems in a manufacturing Process.
• Ability to work effectively as part of a team and independently.

Requirements: