- Fusion Pharmaceuticals (Chelsea, MA)
- …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 (Boston, MA)
- **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
- 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 ...a CMC Project Manager, you will provide project management...management of one or more small molecule products as co- lead with the CMC Lead ;… 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 ... 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
- Takeda Pharmaceuticals (Boston, MA)
- … investigational, registration and/or post-approval strategies for assigned products as GRA CMC Product Lead . + Represents and contributes to Regulatory, ... regulatory requirements and standards. + When in a GRA CMC Product Team lead role, prepares and...across a complex matrix environment in GRA with GRLs, CMC RA project leads and other GRA… more
- Sanofi Group (Cambridge, MA)
- …Familiarity with cGMP and regulatory requirements on analytical methods + Prior CMC project management experience + Excellent communications skills **Preferred ... **Job Title** : Analytical Principal Scientist (Analytical team lead ) **Location:** Cambridge, MA **About the Job** Are...team meetings + Having a record of success in CMC project management + Having working knowledge… 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
- Takeda Pharmaceuticals (Cambridge, MA)
- …projects and data types. **POSITION ACCOUNTABILITIES:** + Contribute to and/or serve as lead representing data science function on project teams in support of ... shine? Join us as a Senior Manager of Statistics- CMC in our Cambridge, MA office. As a Senior...design, analysis, and interpretation of Chemicals, Manufacturing, and Controls ( CMC ) study data throughout Pharmaceutical Sciences. We seek an… 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 (Cambridge, MA)
- **Global Project Head -AATD* SAR447537** **Development** The Global Project Head (GPH) is delegated various responsibilities by the Senior GPH and/orTherapeutic ... Area Head to provide leadership, supervision, and coordination within the Global Project Team (GPT). The GPH position requires achieving results through others 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 (Boston, MA)
- …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
- Bristol Myers Squibb (Devens, MA)
- …commercial products. This role is responsible for developing and executing the CMC strategy for assigned products, managing key technical risks, and ensuring ... technical alignment with stakeholders. As a key member of the CMC and Global Operations (GO) Team, the Product Champion will deliver technical projects aligned to… more
- Takeda Pharmaceuticals (Boston, MA)
- …you and empower you to shine? Join us as a Senior Director, Global Program Leader - Oncology, Solid Tumors in our Cambridge office. At Takeda, we are transforming ... to our inspiring, bold mission. **OBJECTIVES:** The Global Program Leader is a seasoned leader fully dedicated,...through the functional sub-teams leaders and their teams all project deliverables achieve defined project scope &… more
- Sumitomo Pharma (Boston, MA)
- …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 (Cambridge, MA)
- …thought was possible. Ready to get started? **Main Responsibilities** + Serve as GRA Device Lead for DHTs and SaMDs on assigned project teams (early phase, late ... **Job Title:** GRA Device Lead (Associate Director) - Digital Health **Location:** Cambridge,...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 (Boston, MA)
- …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
