- 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, ... of deviations, CAPAs, change controls, and protocols/reports.Collaborate cross-functionally with CMC team, Regulatory, Clinical Operations, and Program Management to… 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
- Insmed Incorporated (NJ)
- …Are you?About the Role:This position is a key role that will provide regulatory CMC (RA CMC ) leadership and strategy to achieve regulatory approvals in various ... countries. As a strategic function, RA CMC is required to collaborate closely with multiple functions...regulatory strategies and identify the gaps and challenges of CMC development to ensure the approvability of the drug… more
- Formation Bio (New York, NY)
- …new treatments to patients faster and more efficiently.About the PositionThe Senior Director , Regulatory Affairs lead is responsible for developing and directing the ... supplemental NDAs/BLAs and other relevant regulatory filings. Provides Regulatory CMC guidance around drug development and manufacturing/supply processes Understands,… more
- Formation Bio (New York, NY)
- …where you will work closely with our business development, legal, clinical, CMC , and data/engineering teams to on-board products with strong IP potential, and ... Comfortable working cross functionally, including partnering with clinical and CMC teams to identify patentable innovations during development, collaborating with… more
- Insmed Incorporated (San Diego, CA)
- …and for the future of science, we're in. Are you?About the Role:The Director , Regulatory Affairs will serve as the regulatory leader on cross-functional teams, where ... senior leadership, as neededCollaborate with Clinical Development, Clinical Operations, CMC , QA/QC, Nonclinical, Program Management, and external consultants to… more
- Merck & Co. (Rahway, NJ)
- …process & connectivity between functions supporting pipeline (ie clinical development, CMC , supply chain, & human health), and balancing needs of patients ... packaging activities as well as supply chain documentation to support critical CMC activities. Support the collection of clinical supply chain metrics and/or… more
- Insmed Incorporated (NJ)
- …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 ... plans for production, packaging, distribution, and clinical supply budgeting. The Director provides strategic leadership for Clinical Supply Chain & Logistics… more
- Legend Biotech USA, Inc. (Philadelphia, PA)
- …an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Sr. Director of Toxicology as part of the Clinical Development team based in ... NJ. Role OverviewWe are seeking a highly experienced and strategic Senior Director of Toxicology to lead and oversee all nonclinical safety assessment activities… more
- Merck & Co. (Rahway, NJ)
- …pipeline programs using fed-batch and continuous manufacturing platforms. The Director , Biologics Process Development (BPD) within the Biologics Process Research ... Commercial Manufacturing groups. The candidate should be capable of leading a cross-functional CMC team and is expected to be adept in managing work with external… more
- Programmable Medicine Operatin (Redwood City, CA)
- …Author and review technical documents such as protocols, reports, risk assessments, and CMC sections of regulatory filings Ability to review master batch records and ... participation in the annual bonus program. At the Associate Director level, the salary range for this position is...is $160,000 - $185,000 annually. The range for a Director is $185,000 $243,000. We consider various factors when… more
- Insmed Incorporated (NJ)
- …personnel and internal cross-functional stakeholders across disciplines of Manufacturing, CMC , Quality, Legal, Procurement and Finance. The ideal candidate would ... and lead work groups. This position reports to the Director , Supplier Relationship Management.What You'll Do: Responsibilities:Support supplier selection sourcing… more
- Programmable Medicine Operatin (Redwood City, CA)
- …to treat diseases with unprecedented precision. This position reports to the Director , Analytical Research and Development and will develop analytical methods and ... skills. *Technical writing experience such as protocols, reports, SOPs, and preparing CMC sections of IND. *Knowledge of GLP & GMP requirements *Well organized… 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 ... translates into skillful and competent application of knowledge to ensure the CMC function is in alignment with the Company's corporate and departmental goals.… more
- Lilly (Indianapolis, IN)
- …support communities through philanthropy and volunteerism. **Position Summary:** The Senior Director , CMC Project Management will provide strategic and ... operational leadership for cross-functional CMC team(s) and will partner with CMC ...cross-functional CMC team(s) and will partner with CMC scientific and technical leaders with accountability for technical… 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 ... CMC development and commercial support. Reporting to the Senior Director , CMC Statistics, you will drive innovation in kinetic modeling, Bayesian statistics,… more
- Teva Pharmaceuticals (West Chester, PA)
- CMC Biologics Quality Control Director , Physichemical Testing Date: Oct 17, 2025 Location: West Chester, United States, Pennsylvania, 19380 Company: Teva ... and lead others through the interdependencies of various functions within the CMC organization Design, plan, organize, analyze, and evaluate key elements of… more
- Boehringer Ingelheim (Duluth, GA)
- …and benefit programs reflect Boehringer Ingelheim's high regard for our employees. The Director , Scientific Expert CMC is responsible for providing new product ... and priorities in close collaboration with Quality, R&D and Operations/Manufacturing. The Director , Scientific Expert CMC provides subject matter expertise in… 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 ... all DP-related activities within the project(s), in support of CMC development within EACD. The Associate Director /Senior...of CMC development within EACD. The Associate Director /Senior Associate Director of EACD for drug… more
- UTMB Health (Galveston, TX)
- Director of Operations, - CMC - Galveston County Jail **Galveston, Texas, United States** Business, Managerial & Finance UTMB Health Requisition # 2503778 The ... time of offer. Standard office environment at UTMB's main campus or other CMC location. Security clearance is required; pre-employment drug testing is also required.… more
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