Manager - Manufacturing Sciences & Technology
On-site · Madison, Wisconsin, United States
Job Summary
Leader of the Manufacturing Sciences & Technology Upstream Tech Transfer group responsible for drafting/reviewing documentation, data assessment, change controls, and technical input for risk analyses and deviations. Responsible for guiding tech transfer from Process Development to GMP manufacturing for mammalian biologics, coordinating with cross-functional teams, and shepherding multiple projects from development through to manufacturing. Manages 5–12 direct reports (engineers/scientists/group leaders), hires/train/supervises staff, supports technology transfer of processes, and ensures data integrity and regulatory compliance while engaging clients and internal stakeholders. Requires strong leadership, communication, and domain expertise across upstream (mammalian cell culture) and associated manufacturing processes, with a track record of delivering complex, cross-functional projects in a CDMO or client-facing setting.
Required Qualifications
- Bachelor’s degree in STEM required
- minimum of 9 years of relevant experience in upstream tech transfer, mammalian cell culture, fermentation, and leadership
- hands-on experience with troubleshooting process equipment in a GMP setting (CDMO or client-facing environment preferred)
- strong systems knowledge (e.g., Microsoft Office, TrackWise or similar QMS, ComplianceWire, Unicorn, DeltaV)
- subject matter expert in upstream (mammalian cell culture) or downstream manufacturing processes (chromatography, filtration, fill)
- ability to clearly communicate technical information to varied audiences about tech/method transfers, OOS, deviations, investigations, and change control
- ability to drive continuous improvement and manage multiple concurrent activities
- leadership experience and ability to mentor and develop staff
- ability to author and review batch production records, tech transfer reports, BOMs, process descriptions, and project reports
- commitment to data integrity and regulatory compliance (cGMP, ICH, FDA)
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