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.
* Contribute/support in various teams as Tech Transfer representative.
* 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
* Writing, maintaining of BOM's (Bill of material) and EBR’s (Paper), gBMR (MES) and SOPs/WI’s.
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 regulations
* Preferred:
* 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.
* Familiarity with risk assessment processes
* Familiarity with the use of Automation systems in a manufacturing Process.
Requirements:
Start: 03.03.2025
Duration: 16 months
Capacity: 5 days per week
Location: Lucerne Metropolitan Area
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