- Gilead Sciences, Inc. (Foster City, CA)
- …implement, and document policies and procedures within the CMC regulatory affairs department under supervision of manager . Participates in initiatives ... aspirations. Join Gilead and help create possible, together. **Job Description** **Sr Associate , Regulatory Affairs, CMC ** **Foster City, California**… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …with 8-10 years pharmaceutical industry experience with 4+ years direct or related CMC regulatory experience or + PhD. with 6-8 years pharmaceutical industry ... Leads US FDA/EU EMA interactions with support from higher-level manager . + ** Regulatory Knowledge:** Demonstrates expert knowledge...experience and 4+ years direct or related CMC regulatory experience + Successful track record… more
- System One (Florham Park, NJ)
- Senior Regulatory Operations Associate Contractor (Publishing) Must be local for Florham Park, NJ (Hybrid 2-3 days onsite) 12-month contract (renewable) Senior ... Regulatory Operations Associate Contractor The Senior ...to provide input on submission timelines in collaboration with Manager , Regulatory Operations. + Ensure consistency across… more
- Novo Nordisk (Boulder, CO)
- …new laboratory completed in 2021 to support analytical and process development, the CMC team works alongside Quality, Regulatory , Technical Operations and RNAi ... improvements that reduce risk and cost to the overall operation. Relationships The Associate , API Manufacturing reports to the Senior Manager , API Manufacturing.… more
- Vera Therapeutics (Brisbane, CA)
- Title: Associate Director, Project Management Location: Brisbane, CA About Us: Vera Therapeutics (Nasdaq: VERA), is a late-stage biotechnology company focused on ... Summary We are seeking a highly skilled and motivated Associate Director, Project Management. The ideal candidate will work...Project Management. The ideal candidate will work with the Regulatory team to develop project plans and to ensure… more
- Takeda Pharmaceuticals (Brooklyn Park, MN)
- …scale down modeling, satellite runs, process validation, data tracking and trending, and supporting CMC regulatory filings. You will report to the Sr. Manager ... true to the best of my knowledge. **Job Description** **Job Title** : Development Associate III **Location** : Brooklyn Park, MN **About the role:** As a Development… more
- CSL Behring (King Of Prussia, PA)
- …knowledge in drug research, development and manufacturing processes of pharmaceuticals ( CMC , non-clinical, clinical, and regulatory ).** **Expert level skillset ... used to treat serious and often rare conditions. Could you be our next Associate Director, R&D Project Planning Capability Lead? This position is located in our King… more
- Bristol Myers Squibb (Devens, MA)
- …modality products (ATMP) environment (eg, research, analytical, quality, engineering, manufacturing, regulatory CMC , or IT). * Knowledgeable of GxP regulations ... excellence, continuous improvement, and process maturity, ensuring compliance with GxP regulatory requirements, BMS Quality standards, and BMS QMS principles. **Key… more
- Amgen (Cambridge, MA)
- …as financial systems and controls. + Understanding of cGMP, Operations and Regulatory / CMC policies and requirements + Knowledge of the contract manufacturing ... patients while transforming your career. Contract Development and Manufacturing Manager **What you will do** Let's do this. Let's...GED and 10 years of Manufacturing experience; Or + Associate 's degree and 8 years of Manufacturing experience; Or… more
- Novo Nordisk (Boulder, CO)
- …new laboratory completed in 2021 to support analytical and process development, the CMC team works alongside Quality, Regulatory , Technical Operations and RNAi ... the Department The Boulder Site is home to the specialized technical operations/ CMC team for oligonucleotides and RNAi therapeutics, continuing its legacy as the… more
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