Msat Process Expert, Vibe-x
vor 1 Woche
The site in Visp, Switzerland is growing and for our Biologics organization, we are currently looking for MSAT Microbial or BioConjugates Process Experts.
Lonza has a strong track record in the microbial and bioconjugation manufacturing of Biologics from early clinical to large scale commercial supplies.
We are building a brand new and unique facility in the Lonza's Vibe-X dedicate model, in which the two technologies of microbial and bioconjugates production are combined in one project.
Key Responsibilities:
- Participation in and/or process owner of the technical transfers, rampup and the commissioning of the facility currently in construction
- As an MSAT process expert, act as the interface between the process donor (customer, process development) and operations. In this function, responsible to ensure process scalability and manufacturability
- Plan and supervise MSAT activities on project level to ensure that the processes deliver the required products with the required quality in a safely, timely and in a cost effective manner
- Directly communicate with customers during campaign execution and closure including daily reporting of batch status and performance
- Responsible for leading process troubleshooting on the manufacturing floor as needed
- Change control management
- Supporting process validation activities
- Participation in annual product review (APQR)
- Representing the facility during process specific inspections and audits as SME for area of responsibility
- Preparation of validation and commercial campaigns as part of a project team (tech transfer, scale up, GMP documentation, equipment)
Key Requirements:
- Master or PhD (preferred) in Bioconjugation, Biotechnology, chemical engineering, organic chemistry or related disciplines
- Significant experience in Bioconjugation or Microbial, biopharma manufacturing and / or process development, preferably in the area of BioConjugates or USP/DSP (Mammalian or Microbial)
- Excellent communication skills for interaction with customers and within the project organization
- Fluency in English, German would be an advantage
- Strong organizational and project management skills
- Structured, solutionoriented, focused and wellorganized working attitude
- Openminded for new ideas and suggestions
People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences.
- Reference: R58571
- Apply
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