- 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
- Lilly (Indianapolis, IN)
- …Lead risk management activities as it pertains to new products (pFMEA) + Own Tech Transfer strategy for the manufacturing site + Ensure that an accurate ... technical support for preparation of relevant technical documents, as required, such as: tech transfer risk assessments / plans / reports, change controls,… more
- Amgen (Thousand Oaks, CA)
- …between program needs and site capabilities. + Build, maintain and improve tech transfer efficiency tools, including utilization of offline characterization ... processing in specific areas such as sterile processing, process characterization, tech transfer and validation. Support commercial drug product manufacturing… 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
- Boehringer Ingelheim (Fremont, CA)
- …responsible to provide technical support for routine operations and to support the transfer and implementation of new processes into BI Fremont's GMP facility for ... analyze data in the Downstream (DS) and Drug Product ( DP ) Manufacturing Science and Technology (MSAT) group. The Senior...Process Science representative on project teams. This position may lead New Product Introduction and GMP operations in the… more
- Amgen (Thousand Oaks, CA)
- …, critical thinking, problem solving and process improvements. As the technology transfer lead , the Senior Engineer must successfully integrate the knowledge ... late-stage drug product teams during process design by bringing awareness of tech transfer business process, manufacturing site capabilities, and collaborating… 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
- Merck (West Point, PA)
- **Job Description** The Biologics Technical Operations lead , reporting to the Global Science, Engineering and Commercialization (GSEC) Large Molecules Technical ... for both commercial and pipeline products. The Biologics Technical Operations lead will partner closely with Biologics Manufacturing Operations leaders to ensure… 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
- Merck (West Point, PA)
- …inclusive of robust processes & analytics, an integrated control strategy, successful tech transfer packages, filing and approval, and a robust commercial ... : Demonstrated expertise of technical aspects and interdependencies across DS, DP , Device, Packaging, and Analytical, Regulatory, Quality, and Supply Chain from… more