- BeOne Medicines (San Mateo, CA)
- …implement small molecule CMC regulatory strategies as well as authoring CTD CMC sections for the assigned project to ensure on-time and high-quality global ... throughout product life cycle. Escalate the critical issues to senior management timely. + Lead or contribute to development...product complaints arise during product lifecycle for the assigned project . + Provide CMC regulatory review for… more
- Kelly Services (South San Francisco, CA)
- …external partnership management across our investigational and commercial portfolio. Reporting to the Senior Director of CMC , you'll be instrumental in ... Director of Drug Substance Manufacturing **Position Type:** Direct hire **Salary:** Director , $245,000-285,0000 Senior Director , $275,000 - $320,000… more
- Gilead Sciences, Inc. (Foster City, CA)
- …than 35 countries worldwide, with headquarters in Foster City, California. ** Senior Director ,** **Product Management** **Team** **Lead** **(Early Phase)** ... operating within the broader Pharmaceutical Development and Manufacturing (PDM) organization, the ** Senior Director , Product Management Team Lead** will lead a… more
- Sumitomo Pharma (Sacramento, CA)
- …dynamic, highly motivated, and experienced individual for the position of **Associate Director , Regulatory Affairs (Oncology).** The Associate Director is part ... (HA) information requests. In addition, this position may represent GRA in project related meetings, develop regulatory strategy and provide regulatory input as… more
- Sumitomo Pharma (Sacramento, CA)
- …a dynamic, highly motivated, and experienced individual for the position of Associate Director Regulatory Affairs. The Associate Director is part of the Global ... part of the Global Regulatory Team (GRT), leads regulatory activities for assigned project (s) in line with the global registration strategy of the product +… more
- AbbVie (Irvine, CA)
- …required by program needs, in partnership with Discovery, Translational, and CMC colleagues contribute to design and implement translational strategies. May ... AbbVie's customers, markets, business operations and emerging issues. Oversees project -related education of investigators, study site personnel and AbbVie study… more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- **Associate Director , Small Molecule Analytical Development** + Lead and oversee phase appropriate method development and optimization for drug substance and drug ... release testing and reporting, providing actionable insights and recommendations to optimize project outputs for the project teams and ensure alignment with… more
- University of Southern California (Los Angeles, CA)
- …gene therapies and other biological products for internal/external users. The Associate Director of Process Development (cGMP) is responsible for all aspects of ... including manufacturing and process development activities, in order to ensure that project deliverables meet schedule, cost, scope, quality, and safety and ensuring… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Gilead and help create possible, together. **Job Description** The Associate Director , Strategic Sourcing & Supplier Management, Medical Devices owns the business ... high complexity. + Communicates issues to line manager and project teams in a timely manner + Support product...management software + Understanding of activities related to the CMC development of biopharmaceuticals + Advanced knowledge of GMPs… more
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