- 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
- Organon & Co. (Plymouth Meeting, PA)
- **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
- 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
- Organon & Co. (Plymouth Meeting, PA)
- …oversight thereof while ensuring the scientific and data integrity, rigor and quality thereof. The director may represent the Clinical Pharmacology function ... **Job Description** **The** **Position** The Director , Clinical Pharmacology Lead will be responsible for contributing and/or devising the clinical pharmacology… more
- BeOne Medicines (Emeryville, CA)
- As Director of R&D Data Enablement / Data Products, you will lead the strategy and execution of building and scaling R&D data foundations and data products that ... data into a strategic asset. You will be responsible for delivering high- quality , reusable, and governed cross-domain operational data foundations, as well as… more
- Organon & Co. (Jersey City, NJ)
- … 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
- 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
- BeOne Medicines (San Mateo, CA)
- …compliance oversight and guidance across Regulatory Operations, Regulatory Affairs, Quality , Safety/Pharmacovigilance, Clinical, CMC , and Regulatory Technology ... **:** The Manager, Regulatory Compliance Programs reports to the Senior Director of Regulatory Compliance and is responsible for driving program-level compliance… 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
- 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
- AbbVie (North Chicago, IL)
- …external third parties. The primary function is to ensure consistent preparation of CMC regulatory submission documents of high scientific and technical quality ... efficient processes for preparation, review and approval of these CMC sections. Plays a critical role in ensuring that...sections. Plays a critical role in ensuring that the CMC submission strategy is aligned closely with the clinical/regulatory… more
