Vacature MSAT Scientist

MSAT Scientist in Geleen

• Acts as technology transfer SME, following Lonza standards for the appropriate clinical phase of a product.

• Ensures seamless flow of knowledge and information across functions, and with other Sites when applicable.

• Maintaining oversight on process capability, through continuous process verification (CPV).

• Provide second line technical/scientific process support.

• Ensures major steps of process transfer including demonstration run, pilot run, Engineering runs and APS runs are performed successfully.

• Masters process technical details; takes care of adequate adaptation of internal documents to process specifics. (manufacturing BRs, risk assessments and transfer protocols and reports)

• Ensures adherence to internal New product implementation procedures for any program. Maintain the knowledge and the history of the product(s) process throughout the entire lifecycle.

• Represent MSAT in multidisciplinary teams during clinical/and commercial phases of the program and drives the MSAT deliverables as per agreed timeline in close collaboration with internal and external parties.

• Lead/support the CRs, investigations and/or assessments on the process of the product(s) assigned when ever MSAT lead/support is required

• Initiate and support investigations and improvement projects (quality, efficiency), based on the CPV output involving cross-functional teams.