- The US Pharmacopeial Convention (USP) (Rockville, MD)
- …Job Overview** The ** Senior Manager , Chemical Manufacturing and Controls ( CMC ) Technical Advisor** is a key technical leadership position within ... environments. **The Senior Manager , Chemical Manufacturing and Controls ( CMC ) Technical Advisor** has the following responsibilities: + Define strategy… more
- Gilead Sciences, Inc. (Foster City, CA)
- …and help create possible, together. **Job Description** **Responsibilities** + The Regulatory Affairs CMC Senior Manager at Gilead is responsible for ... providing strategic direction, tactical support, and technical expertise for CMC regulatory activities and related regulatory initiatives. + Responsible for… more
- Otsuka America Pharmaceutical Inc. (Albany, NY)
- …drug products, and drug-device combination products. + Determine regulatory and scientific/ technical requirements for CMC and GMP related submissions and ... Provide CMC regulatory strategy input and expertise in the...authorities to assure compliance with regulatory, company standards and scientific/ technical requirements. + Develop and execute regulatory strategies for… more
- AbbVie (North Chicago, IL)
- …and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Senior Manager Regulatory Affairs, Chemistry, Manufacturing and Controls ( CMC ) works with ... internal and external partners to deliver products to patients. Prepares CMC regulatory strategies that enable first pass approvals. Develops and manages content… more
- Sanofi Group (Cambridge, MA)
- **Job title** : Digital Product Owner (Associate Director/ Senior Manager ) In Silico CMC **Location:** Cambridge, MA, Framingham, MA or Morristown NJ **About ... and more efficiently. As an Associate Director/ Senior Manager Product Owner for in silico CMC ,...user stories. + Coordinate effectively between business stakeholders and technical teams for your product portfolio. + Track and… more
- Vera Therapeutics (Brisbane, CA)
- Title: Senior Manager , Process Development, Downstream Location: Brisbane, CA About Us: Vera Therapeutics (Nasdaq: VERA), is a late clinical-stage biotechnology ... treatment for patients suffering from immunological diseases. Position Summary: The Senior Manager , Process Development, Downstream will be responsible for… more
- Gilead Sciences, Inc. (La Verne, CA)
- …Sciences La Verne Engineering Project Management Office (PMO) is seeking a ** Senior Manager , Project Management New Product Line Manufacturing - Labeling** ... to pivotal clinical phases, are executed to meet the global product technical transfer timeline, clinical demands, and internal customer expectations. This position… more
- Gilead Sciences, Inc. (Foster City, CA)
- …and help create possible, together. **Job Description** **Key Responsibilities** Senior Manager , Global External Manufacturing Biologics supports uninterrupted ... achieve corporate, cross functional, and departmental goals + In collaboration with Technical Development Organization, part of the team that defines the … more
- RTX Corporation (East Hartford, CT)
- …of the problem + Supporting prioritization and needs of critical Hot Section CMC technical evaluation tools + Developing strong relationships with key internal ... strategy and operational direction of the Ceramics Matrix Composite ( CMC ) CIPT, by leading a 45-50 team consisting of...(BOAS, HPT Vanes, etc) + Collaborating with the Technology Manager , Carlsbad COE and MPE on program technologies needs… more
- Takeda Pharmaceuticals (Lexington, MA)
- …Description** The API Manufacturing Science & Technology (API MST) department provides technical solution to support Small Molecules and Oncology Operating Unit (SMO ... OpU). This is a technical role in a rapidly growing pharmaceutical company where...abreast of the relevant cGMP, ICH and global Regulatory CMC guidance documents. * Communicate successfully to present complex… more