- AbbVie (North Chicago, IL)
- …high complexity utilizing a matrix approach. Leads Chemistry, Manufacturing and Controls ( CMC ) teams and Product Presentation and Device Strategy Teams (PPDST) of ... key member of AST, has accountability for creating a CMC strategy and development plan that aligns with overarching...a differentiated product. Serves as the spokesperson for all CMC functions and ensures information flow among AST and… more
- Lilly (Indianapolis, IN)
- …a P2 in the new role. **Position Summary:** The Associate Director, CMC Project Management will provide strategic and operational leadership for cross-functional ... CMC team(s) and will partner with CMC scientific and technical leaders with accountability for technical deliverables. CMC Project Management is the program… more
- J&J Family of Companies (Horsham, PA)
- …Johnson & Johnson Innovative Medicine R&D is recruiting for a Director, CMC (Chemistry, Manufacturing and Controls) Regulatory Affairs Biologics New Modalities. This ... House, PA; Titusville, NJ; or Raritan, NJ. The Director, CMC Regulatory Affairs Biologics New Modalities will lead a...Affairs Biologics New Modalities will lead a team of CMC regulatory professionals and will be responsible for development,… more
- Takeda Pharmaceuticals (Lexington, MA)
- …This role is within in the R&D GRA Chemistry Manufacturing & Controls ( CMC ) and Devices organization, and will contribute to the team's delivery of critical ... follows: + Champions, independently develops and leads the execution of regulatory CMC investigational and/or registration strategies for assigned products as GRA … more
- J&J Family of Companies (Malvern, PA)
- …**We are searching for the best talent for a Distinguished Scientist, CMC Team Leader, Proteins to be in Malvern, PA or Spring House, ... PA.** **Purpose:** Within the CMC group, you will lead multiple CMC Teams spanning from pre-NME through post-Approval, including Life Cycle Management (LCM).… more
- Gilead Sciences, Inc. (Foster City, CA)
- …possible, together. **Job Description** This exciting role of Regulatory Affairs Associate II, CMC sits in Gilead's CMC Regulatory Affairs - Small Molecule ... + Provides support for designated regional regulatory activities for PDM CMC Project and Commercial Teams, Regulatory Project and Regulatory Submissions Teams,… more
- J&J Family of Companies (Malvern, PA)
- …**We are searching for the best talent for a** **Distinguished Scientist, CMC Team Leader, Protein Conjugates** **to be located in** **Malvern, PA or ... Spring House, PA,** **Purpose:** Within the CMC group, you will lead multiple CMC Teams spanning from pre-NME through post-Approval, including Life Cycle… more
- Boehringer Ingelheim (Ridgefield, CT)
- …competitive advantage lie with our people. The Associate Director, US Product CMC Regulatory Affairs is responsible for the coordination and execution of regulatory ... US market product portfolio. These responsibilities include management of CMC and product labeling changes as well as the...per US FDA regulations. The Associate Director, US Product CMC Regulatory Affairs acts as primary internal contact for… more
- Lilly (Indianapolis, IN)
- …the world. Lilly is looking for regulatory Chemistry, Manufacturing and Control ( CMC ) scientists to join us in developing and bringing life-changing new medicines ... over the world. We are seeking Regulatory Scientist GRA CMC -Parenteral Commercial Products to be a part of the...you will be expected to collaborate with the broader CMC team to provide strategic, tactical, and operational support… more
- Sanofi Group (Morristown, NJ)
- **Job Title:** Manager, CMC Development and Dossiers **Location** : Morristown, NJ **About the Job** The Manager, CMC Development and Dossiers is responsible for ... the coordination and authoring of high-quality Chemistry, Manufacturing, and Controls ( CMC ) documentation. Working closely with the respective SMEs, they support the… more
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