- Gilead Sciences, Inc. (Foster City, CA)
- … regulatory templates, best practices, and procedures. + Coach and mentor junior regulatory CMC RA staff **Qualifications:** + Requires a Bachelor's ... at our Foster City, CA site. **Responsibilities:** + The CMC Regulatory Affairs Associate Director at Gilead...the United States:** As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment… more
- Lilly (Indianapolis, IN)
- …regulatory sciences leadership, decision making, guidance and coaching for CMC regulatory scientists. + Communicates regulatory decisions and strategy ... and regulatory efforts of the team, overseeing CMC regulatory activities for global submissions and...or PhD in Chemistry, Biology, Engineering, or closely related science + 10+ years of experience in CMC… more
- Amgen (New Albany, OH)
- … Site Team is responsible for input to the development and implementation of CMC regulatory strategies and activities for products manufactured at or planned for ... manufacturing, testing (QC/QA or clinical), or distribution in Pharmaceutical/Biotech industry + Regulatory CMC experience + Ability to develop solutions to… more
- Eurofins (Indianapolis, IN)
- … development strategies and submission content. + Makes technical decisions on CMC regulatory issues impacting product submissions across geographies, with ... Eurofins Scientific is an international life sciences company, providing a unique range of analytical...support or guidance from Client GRA- CMC regulatory scientists. + Provide high quality,… more
- Bristol Myers Squibb (Indianapolis, IN)
- …**Summary** The Associate Director of Chemistry, Manufacturing & Controls ( CMC ) - Quality Assurance develops and drives Quality (manufacturing and ... analytical) strategies for CMC activities (drug substance, API, drug product, and analytics)...Quality risks within the Quality organization. + Collaborate with Regulatory to track/own Quality input for ongoing regulatory… more
- Bristol Myers Squibb (Indianapolis, IN)
- …API manufacturing processes. . Author technical reports and source documents to support regulatory filing. . Author CMC sections for IND/NDA for FDA submissions, ... technical projects across various scientific, production, operations, quality and regulatory teams, to support development and commercialization of radiopharmaceuticals.… more
- LGC Group (Petaluma, CA)
- …decades and established the therapeutics activity in 2019. With around 70 staff and two manufacturing trains, Axolabs offers a flexible manufacturing service out ... and stability testing of oligonucleotide API and raw materials in compliance with regulatory standards to ensure the safety and consistency of products. We have an… more
- Deloitte (Cleveland, OH)
- …Required: + 6+ years relevant consulting experience. + 4+ years of Life Sciences industry experience in the Pharmaceutical R&D regulatory affairs function to ... you find innovators committed to sustainable progress, you'll find Deloitte's Life Sciences & Health Care practice. Our leaders work side-by-side to orchestrate and… more
- Gilead Sciences, Inc. (Foster City, CA)
- …collaborations with other CMC functions. + Familiar with lab automation, data science and knowledge management is a plus. + Create Inclusion - knowing the ... aspirations. Join Gilead and help create possible, together. **Job Description** Gilead Sciences is seeking a talented and highly motivated Senior Scientist to join… more
- Gilead Sciences, Inc. (Foster City, CA)
- …& Manufacturing (PDM) and partner with Quality, Supply Chain, Manufacturing, CMC Regulatory Affairs, Clinical Development and Technical Development to ... a state-of-the-art analytical laboratory + Guide the authoring, review and approval of CMC sections in regulatory filings, and support interactions with health… more