- Takeda Pharmaceuticals (Lexington, MA)
- …the best of my knowledge. **Job Description** **About the role** Join us as our ** Global Manufacturing Sciences CMC Lead** and drive **high-impact, ... technology. In this role, you will lead cross‑functional CMC teams, represent Global Manufacturing Sciences (GMSci) in global product governance… 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)_ ... provide project management expertise for strategic initiatives and Chemistry, Manufacturing and Controls ( CMC ) Life Cycle management...products and guide CMC teams with the CMC lead. + Lead Global Technology Transfer… more
- Takeda Pharmaceuticals (Boston, MA)
- …new innovative medicines for our patients around the world through robust CMC processes. Global Manufacturing Science is a part of Global ... create an agile and predictive scientific and technical organization supporting manufacturing and supply of Takeda portfolio products and collaborating with… 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 ... to improve people's lives. We believe our cutting-edge science and manufacturing , fueled by data and...passion. We are seeking a highly motivated and skilled Global CMC Automation & Robotics Leader. As… more
- Sanofi Group (Waltham, MA)
- …dossiers. The CMC Dossier Sciences department within Sanofi R&D Global CMC Development organization has critical roles and responsibilities in leading ... critical in helping our teams accelerate progress. Join our CMC dossier Sciences team as CMC...around the world. Together, we chase the miracles of science to improve people's lives. **Main Responsibilities:** + Lead,… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …validation. + Collaborate with Global Manufacturing , Regulatory Affairs, and Global Quality to explore methods and implement CMC strategies to enable ... the design, analysis, and interpretation of Chemicals, Manufacturing , and Controls ( CMC ) study data throughout Pharmaceutical Sciences . We seek an innovative… more
- Parexel (Boston, MA)
- …improvements to enhance regulatory efficiency and readiness * Participate in monthly CMC Global Regulatory Team meetings to align strategies across functions ... opportunity for an experienced and highly motivated professional to join our Global Regulatory Affairs team as a CMC Regulatory Affairs Senior/Consultant.… more
- Takeda Pharmaceuticals (Boston, MA)
- …beyond EU/US. who has an understanding of scientific principles and regulatory CMC requirements relevant to global drug development and post-market support. ... submissions (considering possible strategic bundling of changes), ensuring compliance with global requirements. + Apply science - and risk-based approaches,… more
- Parexel (Boston, MA)
- …timely and high-quality submissions. Strategic Planning: Under the guidance of the Regulatory CMC Lead, develop and maintain a high-level global regulatory plan ... Regulatory CMC activities for the program, ensuring alignment with global regulatory requirements. Project Management: Serve as the project manager for meetings,… more
- Lilly (Boston, MA)
- …of external providers (CROs, CDMOs) with capabilities in drug product development and manufacturing + Author CMC sections of regulatory submissions (IND, CTA) ... to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work… more