- Bristol Myers Squibb (San Diego, CA)
- …and laboratory equipment + Draft documentation including but not limited to relevant CMC sections in regulatory packages, SOP's, and development reports. + Less ... programs at RayzeBio. This role will help to drive the CMC radiopharmaceutical process development for RayzeBio's novel pipeline. The radiopharmaceutical development… more
- Cardinal Health (Sacramento, CA)
- … submissions within the discipline of chemistry, manufacturing, and controls ( CMC ). The _Sr. Coordinator, Regulatory Submissions Operations_ will use ... **_What Regulatory Submissions Operations contributes to Cardinal Health_** Regulatory Submissions Operations provides regulatory affairs and product… more
- Bristol Myers Squibb (San Diego, CA)
- …This role will work cross-functionally with several departments (Clinical Operations, CMC , Regulatory Affairs, Supply Chain, Drug Safety/PV, Compliance and ... area oversight to ensure quality of work and appropriate compliance with regulatory requirements + Conduct budget negotiations for Medical Affairs IITs, including… 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 ... initiation. + In-depth knowledge of quality systems, validation principles, regulatory /ICH guidelines and multi-product controls preferred. + Departmental representation… more
- BeOne Medicines (San Mateo, CA)
- …collaborate and build strategic relationships with internal (Clinical Operations, Quality, CMC , Regulatory , etc.) stakeholders. + Demonstrates advanced knowledge ... IRT system functionality and Excel modeling. + Understands comprehensive global pharmaceutical regulatory requirements (eg cGMP, ICH/GDP, GCP, 21 CFR Part 11, and… more
- Kelly Services (South San Francisco, CA)
- Kelly(R) Science & Clinical is seeking a Director of CMC Quality for a direct hire opportunity with a leading biopharmaceutical company in South San Francisco, CA. ... South San Francisco, CA 3 days/week. **Position Title:** Director of CMC Quality **Position Type:** Direct hire **Salary:** $245,000-285,0000 **Position Overview**… more
- AbbVie (South San Francisco, CA)
- …functional groups to provide a unified clinical pharmacology position to clinical, CMC and regulatory teams. + Author scientific publications and present ... of expertise and critically evaluate relevant Clinical Pharmacology, PK/PD and regulatory advances and integrate this knowledge into research or development… more
- Gilead Sciences, Inc. (Foster City, CA)
- …(development reports, process description, batch records, etc) Author and review CMC related regulatory sections Demonstrates technical proficiency and ... for purification technology development, platform process evolution, and support of regulatory filings. We are seeking a highly motivated, team-oriented individual… more
- J&J Family of Companies (San Diego, CA)
- …with demonstrated expertise in applying AI/ML to drive program progression. Knowledge of CMC and Regulatory requirements is a plus. * **Leadership & ... Collaboration:** Exceptional communication skills and experience working in cross-functional, matrixed environments. Proven ability to manage strategic initiatives and lead high-performing teams. * **Technical Expertise:** Familiarity with diverse modalities… more
- Gilead Sciences, Inc. (Foster City, CA)
- …and manufacturing scale equipment. + Understanding of FDA, EMA, and ICH regulatory guidelines related to cGMP. + Excellent communication, technical writing, and ... presentation skills and aptitude for creative problem solving. + Demonstrated ability to collaborate and influence cross-functionally. + Experience in statistics, design-of-experiments, and data analysis (eg JMP, Spotfire). + Understanding or experience with… more