- Fujifilm (Holly Springs, NC)
- …North Carolina, United States. **External US** **About This Role** The Tech Transfer Lead of Drug Product ( DP ) manages and coordinates activities ... teams, ensuring compliance with regulations, optimizing processes for efficient transfer of knowledge and technology, and other routine Manufacturing Science… more
- Merck (Rahway, NJ)
- …primary packaging. + Innovate and drive best practices for commercial site tech transfer , facility fit and development of the DP control strategy. + Define ... and Process Performance Qualification (PPQ), site characterization plan and execution, tech transfer control strategy, process development, PPQ readiness, PAI… more
- Sanofi Group (Cambridge, MA)
- …process development, risk assessments, QbD (Quality by Design) control strategy, tech transfer , scale-up and process performance qualification/validation + You ... to product approval. This encompasses drug substance (DS), oral drug product ( DP ) and analytical development, DS/ DP clinical manufacturing, and support of… more
- Regeneron Pharmaceuticals (East Greenbush, NY)
- …review of all master manufacturing records (MRs), standard operations procedures (SOPs), tech transfer reports, validation master plans, and other documentation ... + Serve as the primary Regeneron technical contact for select DP contract manufacturing sites concerning day-to-day activities. + Liaison between Regeneron… more
- Fujifilm (Holly Springs, NC)
- …milestones throughout the scope of the program (eg, contract sign, AD, Tech Transfer [TT], Clinical not Commercial Manufacturing, Quality, QC, Release, ... Ship Deliverables, Transfer In (materials/equipment, methods, documentation), Transfer Out...Define risks and mitigation actions (eg, materials, equipment, long lead times, item specs, methods) + Performs other duties,… more
- Fujifilm (Holly Springs, NC)
- …milestones throughout the scope of the program (eg, contract sign, AD, Tech Transfer [TT], Clinical not Commercial Manufacturing, Quality, QC, Release, ... ShipDeliverables, Transfer In (materials/equipment, methods, documentation), Transfer Out...defines risks and mitigation actions (eg, materials, equipment, long lead times, item specs, methods) + Performs other duties,… more
- Gilead Sciences, Inc. (Foster City, CA)
- …product operations, with responsibility for all aspects of process engineering: tech transfer , process validation, GMP manufacturing support, process monitoring ... and lifecycle management, including overseeing the design of studies, tech transfers completion of investigations and writing/review of technical reports.… more