- RTX Corporation (Carlsbad, CA)
- …engine components. This role is on site at the Ceramic Matrix Composites ( CMC ) Center of Excellence. CMCs are an enabling material that increases the temperature ... capability of jet engine components. Through successful development and application of these materials, P&W will deliver engines that are more fuel efficient, lighter weight and more durable for commercial and military applications. + Partner with engineers to… more
- Gilead Sciences, Inc. (Foster City, CA)
- …management, clinical labeling, distribution including cold chain, import/export, reverse logistics, CMC and GXP regulations. + Prior experience in complex Oncology ... trials is highly-preferred. + Proven strong and effective collaboration, influencing and negotiation skills to work successfully with internal cross-functional group and external suppliers to meet the aggressive clinical study timeline and patient needs.… more
- Gilead Sciences, Inc. (Foster City, CA)
- …reports, process description, batch records, etc) Author and review CMC related regulatory sections Demonstrates technical proficiency and scientific creativity ... in improving platform technology Demonstrates ability in communicating ideas, project strategies and results to team members across functional roles/departments Mentor junior team members on purification process development strategies, experimental design and… more
- University of Southern California (Los Angeles, CA)
- …implementation. Develop and review SOPs, protocols and process development reports. Authoring CMC documentation. + Oversee lab setup and work with cGMP facility ... management to allocate resources and infrastructure for efficient project execution. + Performs other related duties as assigned or requested. The university reserves the right to add or change duties at any time. Successful Candidates Must Demonstrate:… more
- University of Southern California (Los Angeles, CA)
- …release and comparability testing. Generates Chemistry, Manufacturing, and Control ( CMC ) documents for Investigational New Drug (IND) applications. Generates ... validation plans for new products. Works with senior staff to ensure facilities' compliance with all applicable regulations. + Designs, executes, summarizes and presents process development studies while maintaining good documentation practices. Performs gap… more
- Gilead Sciences, Inc. (Santa Monica, CA)
- …Quality Assurance and Control, Calibration, Maintenance, Validation, Supply Chain, and CMC /Regulatory teams is required. + Perform troubleshooting as necessary and ... takes initiative in resolving issues. **Basic Qualifications:** + Masters degree and 3+ years of relevant industry experience + Bachelors degree and 5+ years of relevant industry experience + HS diploma and 9+ years of relevant industry experience **Preferred… more
- BeOne Medicines (San Mateo, CA)
- …and build strategic relationships with internal (Clinical Operations, Quality, CMC , Regulatory, etc.) stakeholders. + Demonstrates advanced knowledge of global ... clinical trials and the drug development process. + Experience in vendor oversight and managing external partnerships and relations. + Experience with comparator sourcing + Understanding of IRT system functionality and Excel modeling. + Understands… more