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Senior Technical Transfer Engineer

INCOG BioPharma · Fishers, Indiana, US

TSMS Engineer – Senior Technical Transfer II The Technical Services and Manufacturing Sciences (TSMS) Technical Transfer Engineer II will be responsible for...

Job description

TSMS Engineer – Senior Technical Transfer II The Technical Services and Manufacturing Sciences (TSMS) Technical Transfer Engineer II will be responsible for supporting all facets of Tech transfer, Process Validation, GMP Floor Support, and Continued Process Verification in accordance with current good manufacturing (cGMP) for clinical and commercial programs. This role will provide strong technical oversight to the production to ensure robust and reliable production processes are established. Essential Job Functions: - Lead multiple complex technical transfer projects simultaneously from development through commercial manufacturing with strategic business impact - Develop and implement advanced process optimization strategies, statistical process control methodologies, and platform technologies across product portfolios - Serve as senior technical lead on cross-functional project teams and manage technical workstreams involving multiple engineers - Provide advanced technical guidance and mentorship to Senior I and Entry Level engineers while developing their technical capabilities - Author complex technical documents including comprehensive risk assessments, CMC supporting document...