- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub team and the RA team ... (eg, US FDA and EU EMA) for assigned projects with support, on CMC matters. This position supports Health Authority Meetings (eg, preIND, EOP2, pre-NDA, Type… more
- Merck & Co. (Rahway, NJ)
- …the business.-- - - Working independently, the Protocol Clinical Supplies Project Manager ( Protocol CSPM) designs strategic and operational plans for all activities ... process & connectivity between functions supporting pipeline (ie clinical development, CMC , supply chain, & human health), and balancing needs of patients… more
- Merck & Co. (Rahway, NJ)
- …arms within the business.-- - - The Program Clinical Supplies Project Manager (Program CSPM) serves as the primary program-level GCS point of contact ... process & connectivity between functions supporting pipeline (ie clinical development, CMC , supply chain, & human health), and balancing needs of patients… more
- Merck & Co. (Rahway, NJ)
- …allocating resources for cross-product delivery and coordinating with investment Manager to ensure appropriate coordination and forecasting.Communicate IT strategy ... explore opportunities for digital innovation.Develop current and future landscapes for CMC overlaid with digital capabilities.Work closely with Product Line Leads to… more
- Merck & Co. (Rahway, NJ)
- …Management Section of the GCS Planning organization. -Working independently, the Inventory Manager Clinical Supplies Project Manager (IM CSPM) creates strategic ... process & connectivity between functions supporting pipeline (ie clinical development, CMC , supply chain, & human health), and balancing needs of patients… more
- ACROBiosystems Inc. (San Diego, CA)
- …target discovery and validation, candidate drug screening and optimization, CMC development, preclinical and clinical studies, commercial production, and companion ... collaboration and continuous learning. Job Summary The Regional Marketing Manager will develop, execute, and monitor local marketing strategies across… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disordersJob Summary: The Regulatory Process Manager will be a key member of the Global Regulatory Affairs (GRA) ... and cross-functional teams (eg, Quality, CSPV, Clinical Operations, Clinical Development, RA CMC ) to keep processes, procedural documents and supporting job aids up… more
- Merck & Co. (Rahway, NJ)
- …areas of Analytical Research and Development, Biologics Process Research and Development, CMC and Regulatory in aspects of control strategy and filings, Quality and ... within the framework of Company policy. The Executive Director will be a manager of managers, with keen focus on coaching and mentoring organizational leaders in… more
- ACROBiosystems Inc. (New York, NY)
- …target discovery and validation, candidate drug screening and optimization, CMC development, preclinical and clinical studies, commercial production, and companion ... phone calls and e-mails as appropriate. Work with the Regional Sales Manager to develop and execute territory sales plans. Extend and develop relationships… more
- Sanofi Group (Morristown, NJ)
- **Job Title:** Manager , CMC Development and Dossiers **Location** : Morristown, NJ **About the Job** The Manager , CMC Development and Dossiers is ... the coordination and authoring of high-quality Chemistry, Manufacturing, and Controls ( CMC ) documentation. Working closely with the respective SMEs, they support the… more
- RTX Corporation (East Hartford, CT)
- …The HSE Ceramics Matrix Composite ( CMC ) Team is looking for an M5 Design Manager to support the CMC Design & Structures Team. This is a technical supervisor ... outsourcing support. The selected candidate will report to the CMC Design & Structures Discipline Manager with...to the CMC Design & Structures Discipline Manager with whom the candidate will coordinate the staffing… more
- WuXi AppTec (Natick, MA)
- …STA Pharmaceutical, a WuXi AppTec Company, has an exciting opportunity for a ** Manager /Senior Manager , CMC Project Management.** This position will be ... responsible for managing DS and DP projects within STA. The position will lead the orderly progression of projects from the proposal stage through project completion by interacting with the client, technical team, and business development team. The incumbent… more
- UTMB Health (Huntsville, TX)
- Warehouse Manager - CMC - Huntsville **Huntsville, Texas, United States** **New** Supply Chain Management UTMB Health Requisition # 2503892 The mission of ... Correctional Managed Care is to address the healthcare needs of underserved patient populations within the Texas Department of Criminal Justice (TDCJ) and the Texas Juvenile Justice Department (TJJD). **_JOB SUMMARY_** **:** To provide administrative and… more
- Kelly Services (Winston Salem, NC)
- **Job Title: Manager , Regulatory CMC (Contractor)** **Hourly Pay Rate: $62.50** **Schedule: Monday-Friday, 9:00 AM-5:00 PM (Must work Eastern Time hours)** ... Remote** **Position Summary:** An advanced therapy biotech organization is seeking a ** Manager , Regulatory CMC (Contractor)** to provide specialized support for… more
- AbbVie (Waltham, MA)
- …LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Senior Manager Regulatory Affairs, Chemistry, Manufacturing and Controls ( CMC ) works ... with internal and external partners to deliver products to patients. Prepares CMC regulatory strategies that enable first pass approvals. Develops and manages… more
- Deloitte (Stamford, CT)
- …a digitally enabled, equitable future of health. Work You'll Do As a Manager you will lead and deliver engagements, or components of large, complex engagements. ... experience + 4+ years Life Sciences Chemistry, Manufacturing, and Controls ( CMC ) experience to include: + Introducing new technologies like GenAI, AI/ML,… more
- AbbVie (North Chicago, IL)
- …Process Engineering, Drug Product Development (DPD), and Quality Assurance (QA) and CMC -Regulatory. Responsibilities: + Manager a small team (3 direct reports) ... R&D) is a global analytical scientific organization responsible for all CMC analytical activities related to the development of AbbVie's pharmaceutical products.… more
- HCA Healthcare (Manchester, NH)
- …for trauma patients and their families throughout their care in the continuum at CMC . The Trauma Program Manager works both independently and in collaboration ... Do you want to join an organization that invests in you as a RN Manager Trauma Program? At Catholic Medical Center, you come first. HCA Healthcare has committed up… more
- Gilead Sciences, Inc. (Foster City, CA)
- …with manager support. + Invests in acquiring knowledge about CMC regulatory intelligence including guidelines and regulatory trends. **Basic Qualifications:** + ... Description** This exciting role of Regulatory Affairs Associate II, CMC sits in Gilead's CMC Regulatory Affairs...Affairs Associate II, CMC sits in Gilead's CMC Regulatory Affairs - Small Molecule Group. Responsibilities and… 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
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