MSAT Scientist

Summary:

The MSAT Scientist acts as process and product SME during technology transfer of a specific process.
The MSAT Scientist acts as Project Team Member in the core team during clinical/commercial phase of a specific  product(s)  throughout  its lifecycle, specific tasks include:

• 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.

MSAT Scientist exhibits high level of independence in executing process transfer activities, knowledge of specific technologies and ensures the timely completion of MSAT deliverables.

Key Accountibilities:

• 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.

Adhere to site quality standards and support internal or external  audits from technical perspective.