Tech Transfer Specialist (M/F/D) 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: Start: asap Duration: 12 months Capacity: 5 days per week Location: Werthenstein, Switzerland |
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