- 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
- Takeda Pharmaceuticals (Lexington, MA)
- …alignment and timely decision-making. Represent Biologics Product Sciences on cross-functional CMC and project teams and collaborate closely with Pharmaceutical ... is true to the best of my knowledge. Job Description Title: Senior Manager , Commercial Biologics Product Science Lead Location: Lexington, MA / Zurich, Switzerland… 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 ... 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 ... regulatory submissions for OPDC R&D products. Performs quality reviews of CMC sections of regulatory submissions. Authors and maintains Standard Operating… 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 (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
- 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
- AbbVie (Worcester, MA)
- …and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The MES Program Manager is an experienced leader responsible for managing large global projects ... multiple manufacturing locations. This individual provides leadership and coordinated project management for all manufacturing and/or technical activities needed to… 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)
- 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 (Northborough, 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
