- AbbVie (North Chicago, IL)
- …(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 strategy… more
- Otsuka America Pharmaceutical Inc. (Albany, NY)
- Provide CMC regulatory strategy input and expertise in the area of investigational, new and marketed biologic and small molecule drug products to assigned ... drug manufacturing processes, GMP and related issues. + Knowledge of CMC regulatory requirements for biologics and small molecules during development and… more
- Gilead Sciences, Inc. (Foster City, CA)
- …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 guiding… more
- Amgen (Holly Springs, NC)
- … 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
- Vera Therapeutics (Brisbane, CA)
- Title: Senior Manager , Early-Stage Biologics Development, CMC Location: Brisbane, CA About Us: Vera Therapeutics (Nasdaq: VERA), is a late clinical-stage ... medical treatment for patients suffering from immunological diseases. Position Summary: The Senior Manager , Early-stage Biologics Development, CMC will be… more
- The US Pharmacopeial Convention (USP) (Rockville, MD)
- …inclusive and collaborative work environment. **Brief Job Overview** The ** Senior Manager , Chemical Manufacturing and Controls ( CMC ) Technical Advisor** is a ... promote engaged, collaborative, and results-driven work environments. **The Senior Manager , Chemical Manufacturing and Controls ( CMC ) Technical Advisor** has… more
- Bristol Myers Squibb (Indianapolis, IN)
- …aims to be the global leader in radiopharmaceuticals. **Position Summary** The Manager ( Sr . Scientist), Radiopharmaceuticals will be responsible for advancing ... processes. . Author technical reports and source documents to support regulatory filing. . Author CMC sections for IND/NDA for FDA submissions, and support … more
- Vera Therapeutics (Brisbane, CA)
- …development programs. The Senior Manager will support both Clinical Regulatory and CMC activities. Responsibilities: * Proactively manage regulatory ... Title: Senior Manager , Clinical Regulatory Location: Brisbane, California About Us: Vera Therapeutics (Nasdaq: VERA), is a late clinical-stage biotechnology… more
- Gilead Sciences, Inc. (Foster City, CA)
- …and improve life by advancing the care of patients with life-threatening diseases. The ** Sr . Clinical Supply Manager ** is a leader that inspires teams while ... Development, Device Development and Clinical Package Engineering, Quality Assurance, Regulatory , Outsourced Manufacturing and Project Management partners to develop… more
- Merck (Rahway, NJ)
- …within the business. Working independently, the Protocol Clinical Supplies Project Manager (Protocol CSPM) designs strategic and operational plans for all activities ... process & connectivity between functions supporting pipeline (ie clinical development, CMC , supply chain, & human health), and balancing needs of patients… more
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