CK QLS is looking for a Tech Transfer Specialist to join a global Biotech company in Lucerne
Duration: 1 year contract
Work: Hybrid
Responsibilities would primarily entail, but are not limited to:
* 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
* Writing, maintaining of BOM's (Bill of material) and EBR’s (Paper), gBMR (MES)
* 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
Candidate’s requirements:
* 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
* Understanding of the general principles of New Product Introduction (Tech Transfer)
* Oral / written communication skills in English (B1) would be must and German desirable
* Experience in a GMP-regulated biological drug substance manufacturing environment, ideally with experience of single-use systems is preferred.
Contact: Please send an updated CV in English to aguimard@ckqls.ch or info@ckqls.ch
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