- Gilead Sciences, Inc. (Foster City, CA)
- …than 35 countries worldwide, with headquarters in Foster City, California. **Sr. Associate, CMC Regulatory Affairs - Biologics ** Gilead Sciences is seeking a ... assume a full-time employment role in the capacity of Senior Associate in Gilead's Regulatory Affairs CMC ...A scientific degree with directly relevant professional experience in biologics development, global CMC regulatory affairs, and… more
- Kelly Services (Vancouver, WA)
- Kelly(R) Science & Clinical is seeking a CMC Project Manager opportunity with a generative AI biotechnology company in Vancouver, WA. If you're passionate about ... CMC development, scale-up, cGMP manufacturing, and quality control for our AI-generated biologics . Manage CMC efforts at CDMOs, ensuring timely development of… more
- BeiGene (San Mateo, CA)
- **General Description:** + The Senior Manager , Regulatory Affairs CMC , is responsible for developing and implementing global regulatory CMC strategies to ... higher-level degree. **Experience:** + Minimum 6+ years of experience in a global CMC regulatory affairs position with expertise in biologics and deep experience… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Join Gilead and help create possible, together. **Job Description** **Key Responsibilities** Senior Manager , Global External Manufacturing Biologics supports ... Development and Manufacturing organization (PDM). Experience in leading the Manufacture of Biologics Drug Substance is a must. This role requires collaboration at… more
- Merck (Rahway, NJ)
- …strategy in alignment with Global Human Health (GHH) brand/ franchise commercial goals. The Biologics VCM Product Manager (PM) works under direction of the VCM ... and execution of end-to-end (E2E) product supply strategies for one or more Biologics products. The VCM Product Manager will be responsible for supporting… more
- United Therapeutics (Silver Spring, MD)
- …and pulmonary diseases, and other orphan diseases. **How you'll contribute** The Senior Regulatory Affairs Manager partners with senior regulatory ... Contribute to the development and implementation of sound preclinical, clinical and CMC regulatory strategies that support the clinical and commercial development of… more
- Gilead Sciences, Inc. (Foster City, CA)
- …for the planning and execution of multiple small molecules and/or biologics CMC programs. The Sr. Project Manager will partner with PDM Product Strategy ... Manager , Project Management** **Location: Foster City** **Specific Responsibilities:** The Senior Project Manager in PDM Portfolio Strategy and Operations… more
- J&J Family of Companies (Spring House, PA)
- …Pre-Clinical/Clinical Development + Sub functionBiotherapeutics R&D + CategorySenior Manager , Biotherapeutics R&D (PL8) + LocationSpring House, Pennsylvania, United ... of a cross-functional teams supporting pre-clinical and clinical programs, focused on CMC development. Primary responsibilities for this role include but are not… more
- Vera Therapeutics (Brisbane, CA)
- …patients suffering from immunological diseases. Position Summary: Reporting into the Senior Vice President, Regulatory and Quality, the Vice President, Quality will ... standards. * Collaborate and establish/maintain procedures in collaboration with CMC Operations, Clinical Development, Clinical Operations, Regulatory Affairs, Nonclinical… more
- West Pharmaceutical Services (Exton, PA)
- …environment and planet through our sustainability efforts. **Job Summary:** This Senior Specialist, Regulatory Project Management (RPM) role is responsible for ... (New Drug Applications), ANDAs (abbreviated new drug applications), BLAs ( Biologics License Applications). They should maintain knowledge of current international… more