- BeOne Medicines (Emeryville, CA)
- …be responsible for development of strategies, planning, drafting, and managing CMC -related regulatory submissions and HA interactions to meet the aggressive ... The individual will provide support to cross-functional teams on CMC regulatory strategies and process optimizations on relevant topics....the job:** + Lead, develop and implement small molecule CMC regulatory strategies as well as authoring CTD … more
- Sumitomo Pharma (Sacramento, CA)
- …seeking a dynamic, highly motivated, and experienced individual for the position of ** Associate Director , Regulatory Affairs (Oncology).** The Associate ... strategy of the product + Supports the global regulatory lead (GRL) and the CMC regulatory lead in the formulation of regulatory strategy, and interactions with HAs… more
- AbbVie (Irvine, CA)
- …join us as a Group Leader based in Irvine, CA reporting to the Director , PDS&T Toxins. Responsibilities: + Manage the protein characterization group by working with ... for a comprehensive understanding of the product structure-function relationship. + Lead CMC analytical development with in-depth knowledge of a broad range of… more
- Takeda Pharmaceuticals (Thousand Oaks, CA)
- …true to the best of my knowledge. **Job Description** **About the role** As Associate Director , API Process Engineering, you will be Takeda's global expert for ... site leadership, Technical Services, Pharmaceutical Sciences, Global Quality, and Regulatory CMC . + Provide technical support to marketing applications for global… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Process & Operational Excellence (OpEx), and part of the larger PDM organization, the Associate Director , Business Processes & OpEx will support the success of ... than 35 countries worldwide, with headquarters in Foster City, California. ** Associate ** ** Director , PDM Business** **Process &** **Operational Excellence**… more
- BeOne Medicines (Emeryville, CA)
- **General Description:** The Associate Director , Global Regulatory Project Management (AD, Global RPM) is a strategic leader responsible for translating and ... with senior stakeholders and cross-functional teams (clinical, medical, safety, CMC , commercial) across regions to achieve strategic business goals through… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Join Gilead and help create possible, together. **Job Description** The Associate Director , Strategic Sourcing & Supplier Management, Medical Devices ... and project management software + Understanding of activities related to the CMC development of biopharmaceuticals + Advanced knowledge of GMPs and associated… more
- Takeda Pharmaceuticals (Thousand Oaks, CA)
- …true to the best of my knowledge. **Job Description** **About the role** As Associate Director , Drug Product Manufacturing Science & Technology, you will be ... with local Technical Services, site leadership, Pharmaceutical Sciences, Global Quality, Regulatory CMC , and other key functions to align on technical decisions and… more
- University of Southern California (Los Angeles, CA)
- …cell and gene therapies and other biological products for internal/external users. The Associate Director of Process Development (cGMP) is responsible for all ... implementation. Develop and review SOPs, protocols and process development reports. Authoring CMC documentation. + Oversee lab setup and work with cGMP facility… more
- Kelly Services (Tarzana, CA)
- …to Santa Monica, CA as needed. The contractor will report to the Associate Director of Manufacturing, NGF70. The Specialist, Manufacturing role will ensure ... or engineering discipline. * Understanding of cGMP process and knowledge of CMC regulatory framework for biologics. * Knowledge of aseptic techniques for primary… more