- 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 (Framingham, MA)
- …Together, we chase the miracles of science to improve people's lives. The Global Regulatory Affairs (GRA) CMC & Device Organization within Sanofi R&D serves ... **Job Title:** Global Regulatory Affairs CMC lead **Location:**...vaccines across their lifecycle. Working at the intersection of science and compliance, you'll develop CMC strategies,… 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
- Sanofi Group (Framingham, MA)
- …into possible for millions. The Associate Director role is a key leadership role in CMC Biologics Drug Product Development and Manufacturing . You will be part of ... **Job Title:** Associate Director- CMC BioDPDM **Location** : Framingham, MA As Associate...process development experience. This person will work closely with manufacturing and process engineering to ensure robust formulation development,… 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
- Takeda Pharmaceuticals (Lexington, MA)
- …application is true to the best of my knowledge. **Job Description** **Title: Global Manufacturing Sciences BioProcess Lead (Sr. Manager)** **Location: ... Zurich, Switzerland / Lexington, MA** **About the role:** As a Global Manufacturing Sciences Bioprocess Lead, you will be an expert responsible for the … more
- Takeda Pharmaceuticals (Boston, MA)
- …to the best of my knowledge. **Job Description** **Title: Process Scientist - Global Manufacturing Science GMSci DP/PKG** **Location: Cambridge, MA** **About ... the role:** As a Process Scientist (Associate Director) - Global Manufacturing Science GMSci Drug...successful collaboration with: + Pharmaceutical Sciences . + Manufacturing Sciences + Global … more
- Sanofi Group (Framingham, MA)
- …from infectious diseases and bring hope to patients and their families. **Sanofi's Global MSAT ( Manufacturing Sciences , Analytics, and Technology)** acts as ... to commercial success, being at the forefront of Data Sciences and Digitalization. Join a team of talented and...industry, specifically in R&D and/or MSAT (industrial development) with manufacturing cGMP considerations, and global CMC… more
- Takeda Pharmaceuticals (Boston, MA)
- …across the CMC internal and external spend in partnership with Finance, R&D, Global Manufacturing & Supply, Global Quality and Commercial functions. + ... and influences strategy, business performance, and transformation initiatives across the global Pharmaceutical Sciences organization with internal sites in… more
- Takeda Pharmaceuticals (Boston, MA)
- …+ Serves as a strategic advisor and technology domain expert for Pharmaceutical Sciences / CMC scientific and clinical manufacturing informatics and digital ... to putting patients first. As the Director, Technology Business Partner for Pharmaceutical Sciences R&D Data Digital and Technology (R&D DDT), you will serve as a… more
- Takeda Pharmaceuticals (Boston, MA)
- …with deep expertise across Pharmaceutical Sciences + Strong understanding of CMC processes, GxP, regulatory compliance and global quality standards + ... / Purpose:_** The Head of Design & Delivery, PharmSci will lead the global digital product strategy across Takeda's Pharmaceutical Sciences Digital Data &… more
- Takeda Pharmaceuticals (Lexington, MA)
- …investigated and addressed with effective CAPAs. + Collaborate closely with Pharmaceutical Sciences , Global Clinical Supply Chain, and other partners to resolve ... **About the role** The Principal Manager, R&D GMP Pharmaceutical Sciences Quality EU & US provides Quality oversight across...compliance. + Serve as GMP QA authority for Pharm Science Teams and provide strategic quality guidance internally and… more
- Takeda Pharmaceuticals (Boston, MA)
- …for global manufacturing strategy alignment. + Effectively communicate Global Manufacturing Sciences visions across the functions. + Understanding ... you contribute:** + Lead the Global Process Science , Small Molecules API Manufacturing Science...a multi-functional team (ie, Engineering, Manufacturing Operations, Manufacturing Sciences , CMC team etc.).… more