- Merck & Co. (Rahway, NJ)
- …while developing and expanding your career.The Chemistry, Manufacturing & Controls ( CMC ) Pre-approval Pharm Executive Director is accountable for managing ... molecules to peptides, pediatric formulations, and devices. The Executive Director , as a senior member of the...and available to patients in markets as needed.-The Executive Director of CMC Pre-approval Pharm holds responsibility… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …product quality and stakeholder satisfactions. Responsible to communicate and escalate to Senior CMC Lead regarding the activity status and potential critical ... areas centered around rare diseases and immune disorders. Summary CMC Lead is responsible for supporting the overall ...CMC Lead is responsible for supporting the overall CMC strategies within projects, and manage project teams. The… more
- Merck & Co. (North Wales, PA)
- Job DescriptionUnder general supervision of an Executive Director / Senior Director , the Principal Scientist / Director is responsible for developing and ... implementing Chemistry, Manufacturing, and Controls ( CMC ) regulatory strategies for our organization's biologics product franchises in accordance with domestic and… more
- Insmed Incorporated (Bridgewater, NJ)
- …Biopharma™, Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Senior Director , Toxicology is a key member of the nonclinical ... safety team, reporting to the Executive Director , Head of Toxicology and Molecular Mechanisms. In this role, you will represent toxicology at cross-functional… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and Oncology, incl. coordinating Reg Intelligence & Policy activities with the Regulatory- CMC function and corporate affairs as needed. In the short term, the ... with DS' strategic objectivesWork with other DS functions (incl. Regulatory- CMC ) to coordinate Regulatory Intelligence activities and ensure regulatory/development… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders.Summary The Associate Director , RACMC Portfolio Products, will be responsible for regulatory CMC ... for working on cross-functional teams, developing and executing post-approval Regulatory CMC strategies, reviewing CMC information and data, authoring … more
- Merck & Co. (Rahway, NJ)
- …a range of modalities including small molecules and peptides.- Within OFS, the Director will influence the strategy, lead activities, and develop a team whose roles ... organizations (Research Division/Manufacturing Division), such as Analytical, Quality, Regulatory CMC , and technical functions, to ensure timebound progression of… more
- Insmed Incorporated (Bridgewater, NJ)
- …Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Director , Toxicology, is a key member of the nonclinical safety team, reporting ... to the Executive Director , Head of Toxicology and Molecular Mechanisms. In this...subject matter experts in discovery, bioanalysis, pharmacokinetics, clinical development, CMC , and program management to drive the overall development… more
- Novo Nordisk Inc. (Boulder, CO)
- …and API candidates in our portfolio. Relationships Reports to Senior Director , Chemical Development (within the CMC team). Essential Functions The successful ... the Department The Boulder Site is home to the specialized technical operations/ CMC team for oligonucleotides and RNAi therapeutics, continuing its legacy as the… more
- Novo Nordisk Inc. (Boulder, CO)
- …the Department The Boulder Site is home to the specialized technical operations/ CMC team for oligonucleotides and RNAi therapeutics, continuing its legacy as the ... laboratory completed in 2021 to support analytical and process development, the CMC team works alongside Quality, Regulatory, Technical Operations and RNAi Early… more
- FUJIFILM Holdings America Corporation (Boston, MA)
- Overview The Associate Director / Director of Business Development, will be an ambitious salesperson who independently works to identify, qualify, negotiate, and ... events to promote FCDI's CDMO offeringsCoordinate sales calls with C-level and senior leaders at client accounts; prepare and lead presentations and facilitate site… more
- Teva Pharmaceuticals (West Chester, PA)
- Senior Director , Regulatory Affairs CMC , Innovative Medicine (Hybrid) Date: Mar 28, 2024 Location: West Chester, United States, Pennsylvania, 19380 Company: ... difference, and new people to make a difference with. **The opportunity** The Senior Director , Regulatory Affairs CMC is responsible to manage and help… more
- Lilly (Indianapolis, IN)
- …determined to make life better for people around the world. ** Senior Advisor/ Director , Global Regulatory Affairs - CMC , Small Molecules** At Eli Lilly, we ... new medicines to patients who need them all over the world. The Senior Advisor/ Director in Global Regulatory Affairs - CMC Small Molecules will leverage… 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 ... the project leader, you will be expected to collaborate with the broader CMC team to provide strategic, tactical, and operational support for market registrations… more
- Merck (North Wales, PA)
- **Job Description** Under general supervision of an Executive Director / Senior Director , the Principal Scientist / Director is responsible for developing ... and implementing Chemistry, Manufacturing, and Controls ( CMC ) regulatory strategies for our organization's biologics product franchises in accordance with domestic… more
- Merck (Rahway, NJ)
- …while developing and expanding your career. The Chemistry, Manufacturing & Controls ( CMC ) Pre-approval Pharm Executive Director is accountable for managing a ... molecules to peptides, pediatric formulations, and devices. The Executive Director , as a senior member of the...available to patients in markets as needed. The Executive Director of CMC Pre-approval Pharm holds responsibility… more
- Takeda Pharmaceuticals (Boston, MA)
- …in order to bring life-changing therapies to patients worldwide. Join Takeda as a Director , GRA CMC Pharmaceuticals, Oligonucleotides where you will lead the GRA ... CMC Pharmaceuticals, Oligonucleotides team, you will report to the Executive Director and Head, CMC Regulatory Affairs, Pharmaceuticals. **How you will… more
- Frontier Medicines (Boston, MA)
- Join Frontier Medicines on an exciting journey as our newest Senior Manager/Associate Director in CMC Development, located at either our Boston or South San ... of our team, reporting directly to the Head of CMC , you'll play an integral role in advancing our...of API and preclinical formulations + Fostering collaboration with CMC and Discovery R&D teams + Conducting development studies,… more
- Takeda Pharmaceuticals (Boston, MA)
- …order to bring life-changing therapies to patients worldwide. Join Takeda as a Senior Director , GRA Pharmaceuticals- Small Molecule where you will establish ... trade associations and acts as an advisor/ liaison to senior management to plan, evaluate and recommend implementation strategy....CMC team, you will report to the Executive Director and Head, CMC Regulatory Affairs -… more
- Gilead Sciences, Inc. (Foster City, CA)
- …more than 35 countries worldwide, with headquarters in Foster City, California._ ** Senior Director - Analytical Regulatory Science** KEY RESPONSIBILITIES The Sr ... Director , Analytical Regulatory Science, is responsible for supervising a...incumbent will support "right first time" global approvals for CMC control strategies and maintain "right to operate" throughout… more
