- Novo Nordisk Inc. (Boulder, CO)
- …With a new laboratory completed in 2021 to support analytical and process development , the CMC team works alongside Quality, Regulatory, Technical Operations and ... The Boulder Site is home to the specialized technical operations/ CMC team for oligonucleotides and RNAi therapeutics, continuing its...RNAi Early Development professionals at our Boulder, Colorado facility and works… more
- Insmed Incorporated (Bridgewater, NJ)
- …The Manager must possess a good understanding of pharmaceutical development processes from pre-clinical development through life-cycle management. This ... Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Manager , Laboratory operations will manage the internal analytical laboratory and… more
- Aequor (Seattle, WA)
- …management, business process management, and optimization skills Familiarity with end-to-end CMC drug development with an understanding of critical milestones ... to multi-task and work in a dynamic, fast paced environment. The Project Manager is closely partnered with the Client&T Leader to enable effective execution of… more
- Novo Nordisk Inc. (Boulder, CO)
- …With a new laboratory completed in 2021 to support analytical and process development , the CMC team works alongside Quality, Regulatory, Technical Operations and ... GalXC and GalXC+ platform products. Relationships This position reports to the Manager , Analytical Development as an individual contributor. Daily interaction… more
- Novo Nordisk Inc. (Boulder, CO)
- …With a new laboratory completed in 2021 to support analytical and process development , the CMC team works alongside Quality, Regulatory, Technical Operations and ... , API Manufacturing. The Specialist, API Manufacturing works with Chemical Development , Analytical Services, Engineering, Facilities, EH&S, Program Management… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …in Daiichi Sankyo's Global R&D organization. At Daiichi Sankyo, the engine of development is the cross functional, empowered and agile Global Project Team (GPT), ... directly accountable to global Development governance. In this key role, the candidate will...complex, global team in charge of a global clinical program designed to support registration and develop value-enhancing life-cycle… more
- Regeneron Pharmaceuticals (Troy, NY)
- The Manager uses CMC program management knowledge within the drug development industry to plan and lead the progress of assigned CMC ... projects/programs of advanced scope with limited guidance. As a Manager , CMC Program Management, a typical day might include the following: + Utilizes CMC… more
- Regeneron Pharmaceuticals (Troy, NY)
- The Manager , CMC Regulatory Sciences for Clinical Submissions leads a team that manages the CMC regulatory submission work across multiple clinical programs ... and/or submissions. As a Manager , CMC Regulatory Sciences , a typical...and for compliance with regulations. + Contributes to the development and execution of CMC regulatory strategies… more
- Regeneron Pharmaceuticals (Troy, NY)
- Regeneron is currently looking for a Manager for our CMC Regulatory Sciences team. We are seeking a highly motivated and experienced regulatory professional ... of world (ROW, ex-US/EU) initial marketing applications. As a Manager , CMC Regulatory Sciences, a typical day...the preparation of global marketing applications. + Support the development and execution of CMC regulatory strategies… more
- Takeda Pharmaceuticals (Boston, MA)
- …with others to support their development + May serve as direct/matrix manager of RAV CMC staff, depending on project. Responsible for prioritization of ... therapies to patients worldwide. Join Takeda as a Director, Regulatory Affairs Vaccines CMC where you will provide program leadership and develop CMC… more
