- Lilly (Philadelphia, PA)
- …to make life better for people around the world. Responsibilities: The Associate / Manager , CMC Regulatory and IMP Manufacturing Operations is a hybrid ... CMC Development supporting the two functional areas. The Associate / Manager is responsible for CMC regulatory operations, CMC change management, and… more
- Lilly (Philadelphia, PA)
- …creative solutions to support communities through philanthropy and volunteerism. **Position Overview:** The Manager - CMC Regulatory is responsible for the ... preparation and delivery of high-quality CMC regulatory submissions. This position supports Lilly/Avid diagnostic radiopharmaceutical marketed products globally.… more
- AbbVie (North Chicago, IL)
- …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
- Orchard Therapeutics (Boston, MA)
- …business priorities. This role represents a unique opportunity to contribute to Regulatory CMC activities supporting maintenance and development of Orchard's ... products in clinical development: . Participate in definition and implementation of Regulatory CMC strategy for assigned program(s). . Collaborate with Technical… 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)
- …Join Gilead 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… more
- Amgen (New Albany, OH)
- … 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)
- …Development in project teams. * Prepare, review, or edit cGMP batch records, CMC regulatory and quality documents. Qualifications: * PhD/MS in relevant life ... Title: Senior Manager , Early-Stage Biologics Development, CMC Location:...addition, the role requires authoring, reviewing, and editing of CMC related regulatory submissions and associated quality… more
- AbbVie (North Chicago, IL)
- …documents of high scientific and technical quality that are compliant with global regulatory requirements. Partners with CMC teams during the development of ... (https://www.tiktok.com/@abbvie) . Job Description This position participates in global regulatory dossier preparation activities by gathering information from internal… more
- The US Pharmacopeial Convention (USP) (Rockville, MD)
- …an inclusive and collaborative work environment. **Brief Job Overview** The **Senior Manager , Chemical Manufacturing and Controls ( CMC ) Technical Advisor** is a ... to promote engaged, collaborative, and results-driven work environments. **The Senior Manager , Chemical Manufacturing and Controls ( CMC ) Technical Advisor** has… more