- Indapta Therapeutics Inc. (San Francisco, CA)
- …The Position: Indapta seeks an experienced, biotech CMC quality professional at a director or senior director level. We offer the autonomy, excitement, ... moving from early to later phase clinical trials. Responsibilities will include: Lead the CMC QA function and partner with clinical, regulatory and CMC teams,… more
- Vir Biotechnology, Inc. (San Francisco, CA)
- The opportunity Vir Biotechnology is seeking a highly motivated, self-driven and enthusiastic Senior Director of Regulatory CMC accountable for ensuring all ... assigned products have a successful regulatory CMC strategy for clinical development and commercialization. You should bring both a track record of successful… more
- San Francisco (San Francisco, CA)
- …THE ROLE Reporting to the Vice President, CMC Operations, the Head of/ Senior Director CMC Operations (Drug Substance) will manage activities related ... Drug substance. Managing complex and intertwined scientific/technical and operational logistical CMC related activities, the position will support the Company's drug… more
- Adverum Biotechnologies (Redwood City, CA)
- The Director /Sr Regulatory Affairs will lead the overall CMC Regulatory strategy for Adverum's gene therapy program/s. This individual will be the key interface ... between the Regulatory and CMC functions, partner with Process Development, Manufacturing, Supply Chain,...and Quality; and assist in ensuring regulatory compliance. The Director /Sr will be responsible for developing, executing, and advising… more
- Rezolute (Redwood City, CA)
- The Senior Director , Global Supply Chain will...and EU.The individual will work amongst a team of CMC experts in a matrix organization, capitalizing on each ... technical communication to Global Health Authorities in support of CMC preparation, CMC query resolution, and plant...RespectRezolute (RZLT) currently anticipates the base salary for the Senior Director , Global Supply Chain role could… more
- Ascendis Pharma A/S (Palo Alto, CA)
- …a dynamic workplace for employees to grow and develop their skills.The 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)
- …countries worldwide, with headquarters in Foster City, California. **About the Role:** The Senior Director , CMC Regulatory Affairs for Biologics is ... with a specific product in Gilead's global portfolio of biological products in CMC Regulatory Affairs. This position will provide leadership at a product level as… more
- Frontier Medicines (South San Francisco, CA)
- Join Frontier Medicines on an exciting journey as our newest Senior Manager/Associate Director in CMC Development, located at either our Boston or South San ... of our team, reporting directly to the Head of CMC , you'll play an integral role in advancing our...capsules, and spray dried dispersions. + Fostering collaboration with CMC , DMPK, Chemistry and Discovery R&D teams + Conducting… 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
- Gilead Sciences, Inc. (Foster City, CA)
- …than 35 countries worldwide, with headquarters in **Foster City, California.** ** Senior Director , PDM Product Strategy Leader** **KEY RESPONSIBILITIES** ... this role leads strategic cross-functional teams responsible for all technical and CMC aspects of the assigned products, from entry into the technical development… more
- BeiGene (San Mateo, 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
- Gilead Sciences, Inc. (Foster City, CA)
- …The Director role in the Analytical Development organization reports to the Senior Director of Analytical Development and is a leader in analytical method ... Join Gilead and help create possible, together. **Job Description** ** Director , Small Molecule Analytical Development, Analytical Development and Operations (ADO)**… more
- BeiGene (San Mateo, 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 Associate Director , DP Commercial Small Molecule in External Supply Quality organization is responsible for ensuring the commercial ... and escalate any quality or compliance issue timely to senior management when needed. + Closely collaborate with the...collaboratively in BeiGene with eg Manufacturing, Supply Chain, Regulatory CMC and other Quality teams like QPs in EU.… more
- BeiGene (San Mateo, 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
