- Merck (Boston, MA)
- …development through commercialization, with practical insight into how these operations generate CMC regulatory content + Understanding of CMC operations, ... transfer of process and product knowledge with reduced error rates Digital CMC will implement digital solutions to install the foundational capabilities needed to… more
- Takeda Pharmaceuticals (Boston, MA)
- …evolving international regulatory requirements (eg, IDMP, SPOR, XEVMPD, eCTD, ePI, PQ/ CMC , CTIS, ESMP) and assess their impact on RIM data. **3. Collaboration & ... technical data concepts into business terms. + Experience with regulatory domains such as Labeling, CMC , and broader Regulatory Affairs processes. + Exposure… more
- Sanofi Group (Cambridge, MA)
- …+ Ensure good communication and cooperation among different functional groups, including CMC Dossier, Regulatory CMC , Research Platform, and Manufacturing ... Ability to operate independently and to prioritize + Familiarity with cGMP and regulatory requirements on analytical methods + Prior CMC project management… more
- Sanofi Group (Cambridge, MA)
- …in early and late stage, development of multiple modalities; experience within regulatory CMC not directly applicable. + Demonstrated experience with preparation ... **Job Title:** Regulatory Strategist **Location** : Cambridge MA/ Morristown, NJ...accelerate progress. As a key member of the Global Regulatory Team (GRT), and strategic partner to the Global… more
- Takeda Pharmaceuticals (Boston, MA)
- …roles, with deep expertise across Pharmaceutical Sciences + Strong understanding of CMC processes, GxP, regulatory compliance and global quality standards + ... & Technology (DDT) portfolio driving innovation and operational excellence across the CMC lifecycle. This leadership role is accountable for shaping and delivering… 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
- Takeda Pharmaceuticals (Boston, MA)
- …application is true to the best of my knowledge. **Job Description** **Title: CMC Project Manager** **Location: Cambridge, MA (Hybrid)** **About the role:** As a ... CMC Project Manager, you will provide project management expertise...& discontinuation, launch execution & global expansion/contraction, COGs management, regulatory activities, product / process. + knowledge, capability &… more
- Takeda Pharmaceuticals (Lexington, MA)
- …strategy), site leadership, Technical Services, Pharmaceutical Sciences, Global Quality, and Regulatory CMC . + Provide technical support to marketing ... analysis you will deepen process understanding, strengthen control strategies, and support regulatory submissions for global markets. You will become the central hub… more
- Takeda Pharmaceuticals (Boston, MA)
- …Pharmaceutical Sciences counterparts. + Other key functional groups such as Global Quality, Regulatory CMC etc. **Leadership** + Provide vision and strategy for ... sites. Process validation, Risk assessment, Global expansion, COGs management, Regulatory Activities, Process / Product knowledge. + Lead projects within… more
- Sanofi Group (Waltham, MA)
- …techniques, sequence analysis, DNA/RNA isolation etc. + Support strategic writing of the CMC section of the regulatory dossier **People:** + Is responsible for ... mRNA platform that brings together R&D, digital capabilities, and CMC expertise under one roof. Bring your ambition and...preclinical and clinical biomarker assays, + Support the overall CMC DS & DP group by analyzing samples via… more