Senior/Principal Scientist Tech Transfer

Senior/Principal Scientist Tech Transfer

Eli Lilly Benelux

Alzey, Germany

In this role you will be part of the TS/MS (Technical Services/Manufacturing Science) team (also known as MSAT or MS&T). The TS/MS team is the technical owner of the process - from tech transfer and validation through commercial lifecycle management. Our decisions on control strategy, lifecycle, and process robustness shape how this greenfield parenteral site runs for the next decades, with direct visibility to site leadership and Lilly's global technical network.

Key Objectives/Deliverables:

• Act as tech transfer lead to own, plan and execute the tech transfer for products on a new aseptic filling line. Represent the sending site as part of the tech transfer.
• Own and coordinate deviations related to the tech transfer and complex deviations with product impact.
• Maintain a deep understanding of product related process aspects and act as point of contact for product related questions for all stakeholders on site (e.g. quality, operations, engineering).
• Management of product lifecycle after start of routine manufacturing.
• Prepare, review and approve technical documents, as required, such as gap assessment, tech transfer plan, development studies and related protocols and reports, change controls, regulatory submissions, deviation investigations, validation protocols and summary reports, processing records, procedures, PFDs, VMPs, and APRs.
• Support and/or lead technical projects (experimental, modeling and/or production data analysis) to improve process control, yield and productivity.
• Provide product related counseling to operations during routine manufacturing.
• Present the tech transfer and product related topics during internal and external inspection.

Expected Qualifications:

• BS or MS in Microbiology, Biology, Biochemistry, Biochemical Engineering, Chemical Engineering, or other related scientific discipline.
• Knowledge of GMP and experience in parenteral manufacturing.Experience in Tech Transfer planning and execution.
• Strong knowledge of risk management and understanding/ability to use risk assessment tools as part of a validation strategy.
• Strong technical writing and presentation skills.
• Fluent in English.

Additional Preferences:

• Prior experience in multiple functions associated with manufacture of parenteral products (e.g. operations, environmental monitoring, sterility assurance validation, microbiology laboratory, technical services, quality assurance, etc.)
• Able to communicate in German.