- Takeda Pharmaceutical (Boston, MA)
- …also represent the drug product process science perspective in regulatory CMC interactions, translating process understanding into clear and defensible filing ... operating unit leaders Local Technical Services organizations Global Quality and Regulatory CMC teams Ensure process knowledge is captured, shared, and reused across… more
- Sanofi Group (Framingham, 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 (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
- 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 (Framingham, MA)
- …program, Gen AI, and others. **Summary of position:** Reporting to digital solution support manager , the **Data Science Project leader** will lead a team to ... **Job title:** _Data Science Project Leader_ + _Location: Framingham, MA_ **_About the...expertise to other operational MSAT DSD platforms to accelerate CMC activities, resolve process issues, and improve process performance.… more
- Takeda Pharmaceuticals (Boston, MA)
- …also represent the drug product process science perspective in regulatory CMC interactions, translating process understanding into clear and defensible filing ... unit leaders + Local Technical Services organizations + Global Quality and Regulatory CMC teams + Ensure process knowledge is captured, shared, and reused across… 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
- Sanofi Group (Waltham, MA)
- …Links with other internal and external stakeholders (such as R&D compliance, Functional Planner, Project Manager , CROs, etc.) + Under supervision of the senior ... diseases and bring hope to patients and their families. The Biostatistics Manager of the TED (Translational and Early Development) team supports Vaccine R&D… 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
- Bristol Myers Squibb (Cambridge, MA)
- …experience (20+years) of drug development or related experience managing clinical and CMC development under a variety of contexts; multiple clinical trials and ... key internal stakeholders and outside of BMS (functional and project leaders, peers and employees at all levels, vendors,...+ US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to… more
