- Vera Therapeutics (Brisbane, CA)
- …experienced, fast-paced and collaborative team. The Senior Manager will report to the Senior Director of Regulatory CMC and will be responsible for ... Job Title: Senior Manager, Regulatory CMC Location: Brisbane, CA About Us: Vera Therapeutics (Nasdaq: VERA), is a late-stage biotechnology company focused on… more
- Gilead Sciences, Inc. (Foster City, CA)
- …than 35 countries worldwide, with headquarters in Foster City, California._ ** Senior Director - Analytical Regulatory** **Science** **KEY** **RESPONSIBILITIES** ... The Sr Director , Analytical Regulatory Science, is responsible for supervising a...incumbent will support "right first time" global approvals for CMC control strategies and maintain "right to operate" throughout… more
- BeiGene (Emeryville, CA)
- **General** **Description:** The Senior Director of CMO and Distribution Logistics, Clinical Supply Chain is responsible for overseeing the Clinical Supply Chain ... (including but not limited to clinical Operation, Quality, Regulatory, CMC , and GRDS) to ensure alignment of organizations and...mitigation plans by working with supply chain leaders and CMC project managers. + Act as point of escalation… more
- Gilead Sciences, Inc. (Foster City, CA)
- …more than 35 countries worldwide, with headquarters in Foster City, California. ** Senior Director , Global Clinical Supply Chain - Inflammation/MAP** **KEY ... RESPONSIBILITIES:** Senior Director , Global Clinical Supply Chain is...clinical labeling, distribution including cold chain, import/export, reverse logistics, CMC and GXP regulations + Proven strong and effective… more
- BeiGene (Emeryville, CA)
- …vendor management team and escalate any quality or compliance issue timely to senior management when needed. + Closely collaborate with the CMO Vendor Management ... cross functionally and collaboratively in BeiGene with eg Manufacturing, Supply Chain, Regulatory CMC and other Quality teams like QPs in EU. + Provide quality… more
- WuXi AppTec (San Francisco, CA)
- …responsible for leading the business development activities within STA, WuXi's CMC small molecule development and manufacturing division. The position works closely ... with STA's other BD team members and senior management team in China to develop and execute the most effective strategy to increase small molecule drug product, API… more
- Frontier Medicines (South San Francisco, CA)
- Frontier Medicines is seeking a highly motivated individual for a newly created Director / Senior Director role in Process Chemistry in Frontier's South San ... + In collaboration with the Development Project Lead and/or CMC Head, define timelines, production scale, and budget to...sections + Interact with cross functional teams to provide CMC technical information, guidance, and support What are we… more
- Ascendis Pharma (Palo Alto, CA)
- …workplace for employees to grow and develop their skills. The Associate Director , Regulatory Affairs will be responsible for developing and implementing global ... regulatory strategies encompassing clinical, non-clinical and CMC disciplines. Ensures timely preparation of organized and scientifically valid submissions. Provides… more
- Gilead Sciences, Inc. (Foster City, CA)
- …their aspirations. Join Gilead and help create possible, together. **Job Description** ** Senior Director , Biologics Drug Product MSAT** Gilead Sciences, Inc. is ... internal regulatory inspections/audits. Participate in writing, reviewing and approving CMC sections of US and international clinical trial applications, regulatory… more
- BeiGene (Emeryville, CA)
- **General Description:** The Director , Clinical Pharmacology & Pharmacometrics will be responsible for developing and executing clinical pharmacology and ... other key functions such as Clinical Development, Biometrics, Biomarkers, Regulatory, CMC etc. Responsibilities will include planning and reviewing study designs &… more