- Fusion Pharmaceuticals (Providence, RI)
- …for Fusion's growing pipeline of RCs. Fusion Pharmaceutical is opening a role for a CMC Project Leader . Reporting to the Vice President of Manufacturing, ... this individual will be responsible for leading CMC efforts for our lead asset, FPI-2265...The successful candidate will bring a strong background in CMC and Project leadership. This position is… more
- WuXi AppTec (Natick, MA)
- …Technical Marketing Specialist- CMC (San Diego, CA) - Analyze pharmaceutical project and technical requirements for CMC projects for business development; ... and conferences, applying knowledge of chemical engineering, biochemistry, pharmaceutical project management, Chemistry, Manufacturing, and Controls ( CMC )… more
- Parexel (Providence, RI)
- **Join Parexel as a Post-Approval Regulatory Strategy Lead !** Are you a strategic thinker with a passion for navigating the complex world of global regulatory ... love to connect. We are seeking a dynamic and experienced Post-Approval Regulatory Strategy Lead to join our Regulatory Affairs team. In this pivotal role, you will… more
- Sanofi Group (Framingham, 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 ... We are seeking a highly motivated and skilled Global CMC Automation & Robotics Leader . As a...CMC /process development with automation/robotics experience, you will define, lead and execute our automation and robotics strategy across… more
- Sanofi Group (Framingham, MA)
- **Job Title:** Global Regulatory Affairs CMC lead **Location:** Framingham, MA, Morristown, NJ **About the Job** Are you ready to shape the future of medicine? ... critical in helping our teams accelerate progress. As GRA CMC Lead within our GRA CMC...+ Develop risk mitigation strategies + Communicate implications to project teams + Articulate risk/benefit components to stakeholders **Contribute… more
- Sanofi Group (Framingham, MA)
- …Associate Director- CMC BioDPDM **Location** : Framingham, MA As Associate Director within CMC BioDPDM, you'll have the opportunity to lead a team in ... Associate Director role is a key leadership role in CMC Biologics Drug Product Development and Manufacturing. You will...of science to improve people's lives. **Main Responsibilities:** + Lead a team of 4-7 staff in formulation and… more
- Sanofi Group (Framingham, MA)
- …to support MSAT programs and global manufacturing sites, and to collaborate with R&D/ CMC teams. + Lead complex manufacturing investigation such as large column ... **Job Title:** Purification Applications Leader -title will align with Sanofi internal title **Location:** Framingham, MA **About the Job** We deliver 4.3 billion… more
- Sumitomo Pharma (Providence, RI)
- …in line with the global registration strategy of the product + Supports the global regulatory lead (GRL) and the CMC regulatory lead in the formulation of ... team based in the US. He/She will primarily function as a regional regulatory leader (RRL) and/or Global Regulatory Leader (GRL) for assigned products. This… more
- Sanofi Group (Framingham, MA)
- …team of talented and passionate international experts, scientists, and project leaders dedicated to inventing, designing, industrializing, and implementing ... product transfers, process monitoring, validation, material management, facility design and CMC requirements. The role will provide scientific expertise supporting … more
- Sumitomo Pharma (Providence, RI)
- …team based in the US. He/she will primarily function as the Regional Regulatory Leader (RRL) and/or Global Regulatory Leader (GRL) for assigned projects. This ... position is expected to lead the development and implementation of regulatory strategy from...Global Regulatory Team (GRT), leads regulatory activities for assigned project (s) in line with the global registration strategy of… more
- Sanofi Group (Framingham, MA)
- …was possible. Ready to get started? **Main Responsibilities** + Serve as GRA Device Lead on assigned project teams (early phase, late stage and marketed ... **Job title** : Global Regulatory Affairs Device Lead (Associate Director) **Location** : Morristown, NJ or...of products. The team is part of the GRA CMC & GRA Device Department within Global R&D. The… more
- Sanofi Group (Framingham, MA)
- …of science to improve people's lives. **Main Responsibilities** + Serve as GRA Device Lead on assigned project teams (early phase, late stage and marketed ... **Job Title:** GRA Device Lead (Associate Director) **Location** : Morristown, NJ/ Cambridge,...of products. The team is part of the GRA CMC & GRA Device Department within Global R&D. The… more
- Merck (Providence, RI)
- …to the Sr. Director of Device Product Assessment & Innovation (DPAI), the Director, Lead of Strategy for Device Product Assessment & Innovation will define and build ... decision-making strategy for all elements of early development. They will lead various early development and innovation initiatives to support continuous improvement… more
- Bausch + Lomb (Providence, RI)
- …influencing key stakeholders, and optimizing business outcomes. **Responsibilities:** + Formulate, lead , and drive integrated regulatory strategies across CMC ... + Participate in assigned due diligence activities for business development and acquisitions. + Lead all CMC regulatory activities for IND, NDA, ANDA, and BLA… more
- Parexel (Providence, RI)
- **Join Parexel as a Post-Approval Regulatory Strategy Lead !** Are you a strategic thinker with a passion for navigating the complex world of global regulatory ... love to connect. We are seeking a dynamic and experienced Post-Approval Regulatory Strategy Lead to join our Regulatory Affairs team. In this pivotal role, you will… more
- Otsuka America Pharmaceutical Inc. (Providence, RI)
- **Associate Director, Small Molecule Analytical Development** + Lead and oversee phase appropriate method development and optimization for drug substance and drug ... product at CDMOs + Design and lead method validation and implementation activities for drug substance...and reporting, providing actionable insights and recommendations to optimize project outputs for the project teams and… more
- Otsuka America Pharmaceutical Inc. (Providence, RI)
- …activities for all assigned projects in alignment with the Global Regulatory Lead . Translates complex pertinent global requirements and provides an assessment of the ... associated regulatory challenges to the GRL, global regulatory team, assigned project teams, and internal/external functional business units as needed. Works… more
- Sanofi Group (Framingham, MA)
- …agreements. + Sends Purchase Orders/Schedule lines to suppliers, respecting suppliers' Lead Time, and updates supplier confirmation for each Purchase Order (order ... and suppliers to maintain MRP Data in systems (MOQ, Lead Times, Safety Stocks, etc.). + As DCO, analyzing...and purchasing systems in a CGMP manufacturing environment + Project management skills + Expertise in document management systems… more
