- Boehringer Ingelheim (Ridgefield, CT)
- …to State Government Affairs and Advocacy, and a key strategic partner to the CMC members (including the Country Managing Director ) on Advocacy areas across all ... direct footprint. Provide strategic counsel and specific direction to BI leadership ( CMC and VP level)on how to influence government officials (Governors, state… more
- Lilly (Philadelphia, PA)
- …and advance care for patients with unmet needs. **Position Overview:** The Director , Analytical Development and Quality Control (AD/QC) is responsible for managing ... and ensure retest and expirations dates can support clinical development and regulatory objectives & timelines + Maintain oversight of precursor and reference… more
- Amgen (Thousand Oaks, CA)
- …role based out of our Amgen Thousand Oaks, CA headquarters and reports to the Senior Director of Process Development. + Accountable for leading a team of process ... skills, including application of scientific theory + Strong experience with regulatory requirements for API/Product ( CMC for IND/NDA, GLP/GMP, ICH)… more
- ThermoFisher Scientific (Wilmington, NC)
- …Experience** **(You MUST show the above in your submittal to be considered)** ** Senior Director Project Mgmt - Oversight** At Thermo Fisher Scientific, you'll ... general medicine and vaccines. **Discover Impactful Work:** We are seeking a ** Senior Director , Project Management** in our **Non-Interventional Oversight Team… more
- Kelly Services (Winston Salem, NC)
- …automation, and data-driven process monitoring and optimization. + Experience contributing to regulatory filings and CMC documentation for global submissions. + ... ** Director , Process Development - Cell Therapy** **Work Schedule...critical process parameter identification, technology transfer, validation activities, and regulatory submission preparation. Strong collaboration with internal stakeholders and… more
- Teva Pharmaceuticals (West Chester, PA)
- …teams to support regulatory submissions. This role reports to the head ( Senior Director ) of Bioassay Department. Location:This is a fully onsite role based ... biosimilars, small molecule specialty medicines, generics and over-the-counter therapies. The Associate Director at Bioassay Department of Biologics CMC leads a… more
- BeOne Medicines (Emeryville, CA)
- …as CMC , Reg Strategy, Clinical/Non-Clinical, Quality/Manufacturing, GTS, Pharmacovigilance and Regulatory Compliance. This position will also play a key role in ... **General** **Description:** This position resides in the Global Regulatory Operations Strategy & Innovation and will interact at all levels, including BeOne's … more
- AbbVie (North Chicago, IL)
- …policies and external agency regulations worldwide. Products include regulatory starting materials, Active Pharmaceutical Ingredients (API), Intermediates, and ... Global Supply Chain, Domestic and International AbbVie Plants and Affiliates, Regulatory Affairs, R&D, and PDS&T to ensure alignment Responsibilities + Support… more
- University of Southern California (Los Angeles, CA)
- … Director , Process DevelopmentApply (https://usc.wd5.myworkdayjobs.com/ExternalUSCCareers/job/Los-Angeles-CA Health-Sciences-Campus/cGMP-Associate- Director ... gene therapies and other biological products for internal/external users. The Associate Director of Process Development (cGMP) is responsible for all aspects of… more
- AbbVie (Cambridge, MA)
- …one aspect of Drug Development (eg, pre-clinical research, clinical development, Regulatory Affairs, Chemistry Manufacturing and Controls ( CMC )). + Experience ... an in-depth understanding of the science behind each of these opportunities. The Associate Director , Search & Evaluation will be a key member of the Specialty and… more
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