- Insmed Incorporated (NJ)
- …each other, and for the future of science, we're in. Are you?About the Role:The Sr. Director CMC QA will lead QA CMC oversight for drug products, biologics, ... phase-appropriate GMP compliance across manufacturing development, while providing strategic Quality leadership across internal teams and external partners. The… more
- Insmed Incorporated (NJ)
- …and for the future of science, we're in. Are you?About the Role:The Associate Director , Regulatory Affairs, CMC will be responsible for reviewing the CMC ... changes, providing regulatory impact assessments, and coordinating with regional RA- CMC leaders to formulate regulatory strategies for post-approval changes. This… more
- Formation Bio (New York, NY)
- …faster and more efficiently.About the PositionFormation Bio is seeking an Associate Director , Program Management - Asset Diligence & Integration to partner with our ... from initial evaluation to pre-close. Coordinate cross-functional workstreams (Clinical, CMC , Regulatory, Nonclinical, QA, Commercial, Finance, Legal/IP). Maintain trackers,… more
- Formation Bio (New York, NY)
- …development of formulations for injection. Cross-Functional Collaboration: Partner with other CMC groups (analytical development, supply chain, etc) quality ... more efficiently.About the PositionFormation Bio is seeking a motivated, experienced Director , Formulation Development to join our dynamic team. This critical role… more
- Merck & Co. (North Wales, PA)
- Job DescriptionThe Associate Director , Regulatory Affairs, supports products in the Oncology therapeutic area as part of a regulatory team.- The individual will have ... Regulatory Operations, Clinical Safety, Labeling, Regulatory Chemistry, Manufacturing and Control ( CMC ) as well as other functional areas (eg, clinical research,… more
- Novo Nordisk Inc. (Boulder, CO)
- …us. Our R&D hub merges biotech speed and agility with large pharmaceutical company quality , resources, and stability, uniting the best of both worlds to develop new ... medicines for patients. The Position Oversee the CMC QA Organization for the site, which includes responsibility...Organization for the site, which includes responsibility for the Quality Assurance (QA) function and serves as the leading… more
- Insmed Incorporated (NJ)
- …maintenance, to ensure robust supply tracking and randomization supportCollaborate with CMC , Clinical Ops, Quality , Regulatory, and Commercial Supply teams ... and for the future of science, we're in. Are you?About the Role:The Director of Clinical Supply Chain Operations is responsible for leading global demand planning… more
- Insmed Incorporated (NJ)
- …trackers, and regulatory archives.Partner with cross-functional teams (Regulatory Affairs, CMC , Clinical, Quality ) to facilitate document authoring, review, ... possible for patients with serious diseases. Reporting to the Executive Director , Regulatory Operations, you'll be responsible for the publishing, management, and… more
- Insmed Incorporated (NJ)
- …external personnel and internal cross-functional stakeholders across disciplines of Manufacturing, CMC , Quality , Legal, Procurement and Finance. The ideal ... and lead work groups. This position reports to the Director , Supplier Relationship Management.What You'll Do: Responsibilities:Support supplier selection sourcing… more
- Organon & Co. (Jersey City, NJ)
- **Job Description** **The Position?** Reporting to the Director in Organon Regulatory CMC ,?the Associate Principal Scientist is responsible for?developing ... and?implementing Regulatory Chemistry, Manufacturing & Controls ( CMC ) strategies for?assigned?small molecule products in accordance with global regulations… more
- Organon & Co. (Plymouth Meeting, PA)
- … Director in Organon Regulatory Chemistry, Manufacturing and Controls ( CMC ), the Associate Principal Scientist is responsible for developing and implementing ... Regulatory Chemistry, Manufacturing & Controls ( CMC ) strategies for assigned small molecule or biological products in accordance with global regulations and… more
- Emanate Health (Covina, CA)
- …STAR measures coding related functions. The coding specialist will work with the IPA Director , Health Plan, and MSO personnel on HCC and STAR measures related tasks. ... systems. Excellent customer service skills required. **c.Minimum License Requirement :** CMC , CCS, CPC, or COC required. Delivering world-class health care one… more
- Teva Pharmaceuticals (West Chester, PA)
- CMC Biologics Quality Control Director , Physichemical Testing Date: Nov 15, 2025 Location: West Chester, United States, Pennsylvania, 19380 Company: Teva ... results of the physiochemical functional area as well as support the performance and quality of results for the QC department Understand and lead others through the… more
- Xeris Pharmaceuticals, Inc. (Chicago, IL)
- **Overview** The Director , CMC provides leadership for the Chemistry, Manufacturing and Controls ( CMC ) function for Xeris' commercial and clinical/late-stage ... company clinical trials. + Collaborates with other external functions on CMC matters (eg, Quality , Commercial, Regulatory Affairs, etc.). Ensures the CMC … more
- Lilly (Philadelphia, PA)
- …and advance care for patients with unmet needs. **Position Overview:** The Associate Director , CMC Development will be responsible for the execution of multiple ... radiopharmaceutical CMC development and manufacturing programs supporting various therapeutic areas within Lilly Avid. In this capacity, this role will drive the… more
- Boehringer Ingelheim (Duluth, GA)
- …in close collaboration with Quality , R&D and Operations/Manufacturing. The Director , Scientific Expert CMC provides subject matter expertise in functional ... reflect Boehringer Ingelheim's high regard for our employees. The Director , Scientific Expert CMC is responsible for...goals. + Defines, plans, and oversees the development of high- quality CMC regulatory submissions, with a focus… more
- Boehringer Ingelheim (Ridgefield, CT)
- …Ingelheim is currently seeking an Associate Director or Senior Associate Director to join our External Alternative CMC Development (EACD) department located ... for leading all DP-related activities within the project(s), in support of CMC development within EACD. The Associate Director /Senior Associate Director… more
- Lilly (Indianapolis, IN)
- …better for people around the world. Lilly is looking for post approval regulatory CMC scientists to join us in delivering life-changing new medicines to patients who ... need them all over the world. The Senior Advisor/ Director Post approval scientist in Global Regulatory Affairs -... Post approval scientist in Global Regulatory Affairs - CMC commercial solid oral products will use CMC… more
- Amgen (Washington, DC)
- …team. Join us and transform the lives of patients while transforming your career. ** Director , CMC Modeling & Advanced Statistics** **What you will do** Let's do ... for CMC development and commercial support. Reporting to the Senior Director , CMC Statistics, you will drive innovation in kinetic modeling, Bayesian… more
- BeOne Medicines (San Mateo, CA)
- …be responsible for development of strategies, planning, drafting, and managing CMC -related regulatory submissions and HA interactions to meet the aggressive ... projects. The individual will provide support to cross-functional teams on CMC regulatory strategies and process optimizations on relevant topics. **Essential… more
