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.
