- University of Southern California (Los Angeles, CA)
- …of cell and gene therapies and other biological products for internal/external users. The cGMP Process Development ( PD ) Specialized Lab Technician at ... USC/CHLA cGMP Facility is responsible for supporting process development activities related to the scale-up...process optimization and development studies. The Process Development ( PD ) Specialized Lab… more
- University of Southern California (Los Angeles, CA)
- …operators and new team members on manufacturing procedures, QC testing, and process development protocols. Maintains compliance with all safety protocols, ... USC's Keck School of Medicine, current Good Manufacturing Practices ( cGMP ) facility is seeking a qualified cGMP ...and transduction using viral vectors). Works closely with manufacturing, PD , QA, and QC teams to align processes, troubleshoot… more
- University of Southern California (Los Angeles, CA)
- …operators and new team members on manufacturing procedures, QC testing, and process development protocols. Maintains compliance with all safety protocols, ... requirements and guidelines (eg, FDA, EMA) related to cGMP . Preferred Education: Master's degree Preferred Experience: 4 years in cell therapy development more
- Lotte Biologics USA LLC (Syracuse, NY)
- …across teams. This role will also drive operational alignment across Manufacturing Operations, Development (MS&T, PD , AS&T), Quality, Supply Chain, and Business ... to reliably deliver benefits for patients worldwide. Position Summary The Associate Director , Project Management Office (PMO) will play a key leadership role in… more
- Amgen (Holly Springs, NC)
- …of a cross-functional team (ie, QA/QC, F&E (Facilities & Engineering), PPIC, Mfg., PD ( Process Development ), Regulatory, etc.) in completing production ... a regulated industry such as biotechnology or pharmaceutical + Basic understanding and process experience in a cGMP manufacturing facility + Excellent verbal and… more
- Bristol Myers Squibb (New Brunswick, NJ)
- …drug product administered to patients in clinical studies worldwide. In Global Product Development and Supply the team works closely with our partners to deliver ... Manufacturing facilities. + Demonstrates knowledge of mechanical systems, utilities & process equipment required to operate and maintain facilities associated with… more
- ThermoFisher Scientific (Plainville, MA)
- …, a division of Thermo Fisher Scientific. At VVS, we deliver from process development through commercial supply, offering the expertise and resources vital ... manufacturing, and the transfer and validation of assay methods from clients and/or Assay Development & Analytics to the cGMP QC testing laboratory. The manager… more
- Lilly (Indianapolis, IN)
- …partners in support of executing the portfolio of both early phase development assets within PR&D, SMDD and BRD. **Key Objectives/Deliverables:** + Support delivery ... + Review and approve manufacturing documentation + Disposition API, in- process materials, dosage forms and finished drug product to...Early Phase materials + Provide QA input to CM&C Development Plans as part of Early Phase deliverables. +… more
- Sanofi Group (Framingham, MA)
- …inventory/supply management. The Technical Pilot Plant (TPP) group supports bioprocessing development with process scale production of Monoclonal Antibodies and ... that could turn the impossible into possible for millions. Biopharmaceutics Development at Sanofi develops and implements manufacturing processes for biologics… more
- Amgen (New Albany, OH)
- …in a Packaging facility. Responsibility includes maintaining production in full cGMP compliance. Supervises, hires, and develops staff and ensures production ... + Evaluate and approve reports and protocols. + Ensure cGMP and CFR compliance of operating areas. + Revise,...+ Revise, update, and review procedures + Manage the development and revision of SOPs. + Evaluate current operating… more
- PHC North America (IL)
- …closely with customers, sales, marketing, R&D, and product management to support process development , scale-up, and clinical/commercial manufacturing in cell and ... + Serve as subject matter expert (SME) for new cGMP bioreactor systems supporting cell culture manufacturing processes +...7 years of experience in cell and/or gene therapy process development or manufacturing + Strong hands-on… more