- 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
- 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
- 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