MSAT Process Specialist

vor 1 Monat

FenilsurCorsier, Schweiz Randstad (Schweiz) AG Vollzeit
Jobdescription
For our client Merck in Corsier-sur-Vevey, we are looking for an MSAT Process Specialist for a period of 12 months.

Your role:

Within the MSAT (Manufacturing Sciences And Technology) team, you support our GMP manufacturing USP and DSP processes in order to increase productivity and quality thanks to the continuous monitoring of our products, troubleshooting, investigations, process and cleaning validation. You foster a strong and positive collaboration with the Support & Production teams, MSAT Project Management team and the Global MSAT network, sharing your USP and DSP expertise.

Job Requirements:
  • Ensure an efficient and timely support for production through leadership of troubleshooting and investigations as agreed with SPM and management
  • To support the clinical production, from the preparation of the tech transfer to the Process Performance Qualification, and to support the clinical campaigns, especially through the coordination of the preparation of Process Control Strategies, sampling plans, protocols and reports.
  • Participate to Continued Process Verification for commercial products (CPV protocols, weekly trend review, quarterly and annual product review)
  • Work in close collaboration with the different groups within the MSAT organization (MSAT Lab and Site Project Managers, Global MSAT) as well as other partners (Production units and BioProcess Sciences). You may also collaborate with other Merck and external entities.

Who you are:
  • MSc. in Biotechnology/Life Sciences/Chemistry with at least 2 or 5 years of relevant experience, respectively
  • Significant experience in USP and DSP processes, recombinant protein production and biopharmaceutical technologies
  • Knowledge of QbD and statistics (e.g., equivalence tests, DOE, MVA) would be considered as a plus
  • Awareness of cGMP related issues and Health Authorities requirements
  • Experience with cGMP documentation redaction
  • Ease and appetite to work in a team. Strongly problem solving and result oriented
  • Comfortable with delivering commitments, being accountable for them to her/his manager and customers, and communicate on their related status in a matrix environment
  • Languages: French and English (oral and writing)
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