- Takeda Pharmaceuticals (Boston, MA)
- …worldwide. This role is within in the GRA Chemistry Manufacturing & Controls ( CMC ) and Devices organization, and will contribute to the team's delivery of critical ... follows: + Independently develops and leads the execution of regulatory CMC investigational, registration and/or post-approval strategies for assigned products as… more
- BeOne Medicines (Emeryville, CA)
- …be responsible for development of strategies, planning, drafting, and managing CMC -related regulatory submissions and HA interactions to meet the aggressive ... The individual will provide support to cross-functional teams on CMC regulatory strategies and process optimizations on relevant topics....the job:** + Lead, develop and implement small molecule CMC regulatory strategies as well as authoring CTD … more
- Sanofi Group (Morristown, NJ)
- **Job Title:** Head of Global Regulatory Affairs, CMC Small Molecule **Location:** Morristown, NJ **About the job** Join the engine of Sanofi's mission - where deep ... possible for millions. **Our Team/ Overview:** The Global Regulatory Affairs (GRA) CMC & Device Organization serves as a critical strategic partner within Sanofi's… more
- Sanofi Group (Framingham, MA)
- **Job Title:** CMC Project Manager **Location:** Framingham, MA **About the Job** Join the engine of Sanofi's mission - where deep immunoscience meets bold, ... could turn the impossible into possible for millions. The CMC Project Manager is a key contributor of the... Project Manager is a key contributor of the CMC Project Excellence department to provide a world class… more
- Taiho Oncology (Princeton, NJ)
- …dynamic and expanding mid-size company in the role of Director for Regulatory CMC directly reporting to Executive Director, Regulatory CMC . Your expertise will ... play a pivotal and visible role in advancing CMC strategy and submissions of developmental, life cycle and...With minimal direction the incumbent manages the global regulatory CMC activities except Asia for all assigned Taiho Oncology… more
- Takeda Pharmaceuticals (Lexington, MA)
- …Description** **About the role** Join us as our **Global Manufacturing Sciences CMC Lead** and drive **high-impact, high-visibility CMC projects for innovative ... provide technical and strategic leadership for Chemistry, Manufacturing and Controls ( CMC ) of one or more late‑stage or commercial biopharmaceuticals with potential… more
- Sanofi Group (Framingham, MA)
- **Job Title:** CMC Dossier Leader **Location:** Framingham, MA/ Waltham, MA **About the Job** Join the engine of Sanofi's mission - where deep immunoscience meets ... could be critical in helping our teams accelerate progress. Join our CMC dossier Sciences team as CMC dossier leader and you'll contribute to the CMC … more
- Otsuka America Pharmaceutical Inc. (Augusta, ME)
- **Job Summary** The Chemistry, Manufacturing and Controls ( CMC ) Global Regulatory Affairs (GRA) professional is responsible for developing and executing global ... regulatory strategies for CMC aspects of small molecule products during late-stage development and throughout the commercial lifecycle. This includes initial… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Building** + Develop a roadmap that fosters innovation to assist where and when CMC RA invest resources and budget. + Own continuous improvement of the operating ... model and capability roadmap for the CMC RA function. + Creating and implementing functional business...strategic initiatives, centralize activities, and foster cross-functional support of CMC RA's processes, systems, data, and tools. + Define… more
- Sanofi Group (Cambridge, MA)
- **Job Title:** Global CMC Automation and Robotics Leader **Location:** Framingham, MA or Cambridge, MA or Waltham, MA **About the Job** Are you ready to shape the ... possible. Ready to get started? Within Sanofi R&D, the CMC Data Sciences organization is a key enabler of...We are seeking a highly motivated and skilled Global CMC Automation & Robotics Leader. As a strong global… more
- System One (Indianapolis, IN)
- Job Title: CMC Data Integration Specialist Location: Indianapolis, IN (Hybrid) Hours/Schedule: Monday-Friday, 8 am to 5 pm Type: Contract Overview The CMC Data ... Specialist will support data migration and process improvement initiatives within CMC operations. Working closely with subject matter experts and project managers,… more
- Boehringer Ingelheim (Athens, GA)
- …Boehringer Ingelheim's high regard for our employees. The Director, Scientific Expert CMC is responsible for providing new product and marketed product regulatory ... strategy in the Global Regulatory Affairs (RA) Chemistry, Manufacturing and Controls ( CMC ) function for pharmaceutical biotech and vaccine products in line with… more
- Sanofi Group (Morristown, NJ)
- **Job Title:** Solution Architect - RnD - In-Silico CMC **Location:** Morristown, NJ Cambridge, MA **About the Job** At Sanofi, we're committed to providing the ... team. Mostly dedicated to Digital In Silico Research & CMC Operations domain, you will be a key strategic...leaders to establish the Digital In Silico Research & CMC technology strategy, in alignment with Sanofi's Digital global… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …inspire you and empower you to shine? Join us as a Senior Manager of Statistics- CMC in our Cambridge, MA office. As a Senior Manager of Statistics, you will provide ... in the design, analysis, and interpretation of Chemicals, Manufacturing, and Controls ( CMC ) study data throughout Pharmaceutical Sciences. We seek an innovative and… more
- UTMB Health (Webster, TX)
- Utilization Review Case Mgr - CMC - Clear Lake Center - M-F, 8:00 AM - 5:00 PM **Webster, Texas, United States** Nursing & Care Management UTMB Health Requisition # ... **:** Utilization Management + Demonstrates thorough knowledge of Inter Qual Criteria, CMC Specialty Referral Guidelines and Protocols used to determine status for… more
- Takeda Pharmaceuticals (Lexington, MA)
- …of my knowledge. **Job Description** **About the role** Join us as our ** CMC Sr. Project Lead** , **_Global Biologics Manufacturing Sciences_** _(GMsci Bio)_ and ... expertise for strategic initiatives and Chemistry, Manufacturing and Controls ( CMC ) Life Cycle management (LCM) activities, utilizing technology platforms to… more
- Takeda Pharmaceuticals (Boston, MA)
- …to bring life-changing therapies to patients worldwide. The Director Regulatory Site CMC ensures efficient and compliant management of regulatory change control and ... beyond EU/US. who has an understanding of scientific principles and regulatory CMC requirements relevant to global drug development and post-market support. Who has… more
- GE Aerospace (Evendale, OH)
- …Process Engineer to join our team in Evendale, working in the CMC Lean Lab. This role combines tactical responsibilities with strategic contributions, focusing ... on the development and optimization of Ceramic Matrix Composite ( CMC ) manufacturing processes, including autoclave operations. The ideal candidate will have… more
- Regeneron Pharmaceuticals (Troy, NY)
- Leads the Chemistry, Manufacturing, and Controls ( CMC ) & Combination Products (CP) Internal Medicine team. The candidate will be responsible for the development and ... Authority. **A typical day might include:** + Oversee the assigned CMC /CP Regulatory Affairs team, driving global regulatory strategies and operational direction… more
- Bristol Myers Squibb (Indianapolis, IN)
- …critical to advancing our preclinical development, Chemistry, Manufacturing, and Controls ( CMC ) strategy and ensuring successful technology transfer to clinical and ... experiments for pre-clinical development of radiopharmaceuticals. . Drive and support CMC process development and optimization for clinical drug products, including… more