- Sanofi Group (Cambridge, MA)
- **Job Title:** CMC Project Manager **Location:** Framingham, MA **About the Job** Join the engine of Sanofi's mission - where deep immunoscience meets bold, ... R&D, you'll drive breakthroughs that could turn the impossible into possible for millions. The CMC Project Manager is a key contributor of the CMC … 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 to CMC LCM activities for Takeda's small molecule portfolio. You will… more
- Parexel (Boston, MA)
- …options to patients. We are currently seeking a dedicated and detail-oriented **Regulatory CMC Project Manager ** to join a growing, dedicated client ... regulatory requirements. Project Management: Serve as the project manager for meetings, adhering to best...3+ years proven experience in regulatory affairs, particularly in CMC (Chemistry, Manufacturing, and Controls). + Strong project… more
- Takeda Pharmaceuticals (Lexington, MA)
- …approaches to reduce COGs and strengthen supply reliability. + Collaborate closely with an assigned CMC Project Manager (who will provide you PM support). + ... the role** Join us as our **Global Manufacturing Sciences CMC Lead** and drive **high-impact, high-visibility CMC ...Sciences CMC Lead** and drive **high-impact, high-visibility CMC projects for innovative biologics in a dynamic global… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …standards. Lead responses to Health Authority questions and deficiency letters. + Represents CMC RA in project team meetings and provides expert interpretation ... of regulatory guidelines and perspective to the cross-functional team. Serve as CMC regulatory lead on global project teams (Pharmaceutical Development, Quality,… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …company that will 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 ... in the design, analysis, and interpretation of Chemicals, Manufacturing, and Controls ( CMC ) study data throughout Pharmaceutical Sciences. We seek an innovative and… more
- Merck (Boston, MA)
- …Analytics, Data Governance, Digital Literacy, Digital Transformation, Informatica Metadata Manager , Management Process, Process Flow Documentation, Project ... implement the approach of structured content management. They will also support project management activities to ensure efficient execution and compliance within … more
- Shuvel Digital (Boston, MA)
- …Certifications + IT and Technology-Specific Certifications + Certified Information Systems Project Manager (CISPM) + ITIL Certification (Information Technology ... Project /Program Manager Boston, MA - Hybrid... Project /Program Manager Boston, MA - Hybrid (Remote and In...Infrastructure Library) + Certified Management Consultant ( CMC ) + Leadership in Energy and Environmental Design (LEED)… more
- Takeda Pharmaceuticals (Lexington, MA)
- …and timely decision-making. + Represent Biologics Product Sciences on cross-functional CMC and project teams and collaborate closely with Pharmaceutical ... true to the best of my knowledge. **Job Description** **Title: Senior Manager , Commercial Biologics Product Science Lead** **Location: Lexington, MA / Zurich,… more
- Sanofi Group (Cambridge, MA)
- **Job title:** Lab Software Engineering Manager - Digital R&D Labs and Plants **Location:** Cambridge, MA **About the job** Ready to push the limits of what's ... **Job Summary:** We are seeking a Lab Software Engineering Manager , to lead our team of embedded R&D lab...of cutting-edge software solutions that transform Sanofi's laboratory and CMC manufacturing plant operations As a Lab Software Engineering… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …associated regulatory challenges to the GRL, global regulatory team, assigned project teams, and internal/external functional business units as needed. Works ... the associated regulatory challenges to the GRL, global regulatory team, assigned project teams, and internal/external functional business units as needed. - Works… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- The Senior Manager , Global Product Quality - Biologics is responsible for managing quality oversight of clinical and commercial products at CMOs under contract by ... of regulatory submissions for OPDC R&D products. Performs quality reviews of CMC sections of regulatory submissions. + Authors and maintains Standard Operating… more
- Takeda Pharmaceuticals (Boston, MA)
- …The GPL ensures through the functional sub-teams leaders and their teams all project deliverables achieve defined project scope & objectives, budget and ... on the sub-team objectives. + Accountable with the responsible Global Program Manager for activities operating budgets within the global program; leads budget… more
- Sanofi Group (Framingham, MA)
- …planned with the right coverage targets as defined by Policy or Critical Material Manager (GSP) in case of exceptions / deviations * Reporting of deviations to ... coverage targets to Critical Material Manager (GSP) + Reviews SAP requisitions or Site Scheduler...and purchasing systems in a CGMP manufacturing environment + Project management skills + Expertise in document management systems… more