- WuXi AppTec (Natick, MA)
- …STA Pharmaceutical, a WuXi AppTec Company, has an exciting opportunity for a ** Manager / Senior Manager , CMC Project Management.** This position will ... lead the orderly progression of projects from the proposal stage through project completion by interacting with the client, technical team, and business development… 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). + ... Description** **About the role** Join us as our **Global Manufacturing Sciences CMC Lead** and drive **high-impact, high-visibility CMC projects for innovative… 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 (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 (Waltham, MA)
- …with other internal and external stakeholders (such as R&D compliance, Functional Planner, Project Manager , CROs, etc.) + Under supervision of the senior ... **Job Title:** Sr . Non-Clinical Biostatistician **Location:** Swiftwater, PA **About the...bring hope to patients and their families. The Biostatistics Manager of the TED (Translational and Early Development) team… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …innovative company that will inspire you and empower you to shine? Join us as Senior Manager of Nonclinical Statistics in our Cambridge, MA office. As a ... Senior Manager of Statistics, you will provide...candidate will span across both Chemicals, Manufacturing, and Controls ( CMC ) and focused areas of drug discovery with specific… more
- Takeda Pharmaceuticals (Lexington, MA)
- …is true to the best of my knowledge. **Job Description** **Title: Senior Manager , Commercial Biologics Product Science Lead** **Location: Lexington, MA ... biologics portfolio. In this role, you will be a senior subject matter expert across one or more products...timely decision-making. + Represent Biologics Product Sciences on cross-functional CMC and project teams and collaborate closely… more
- Bristol Myers Squibb (Devens, MA)
- …work and in their personal lives. Read more: careers.bms.com/working-with-us . **Position: Senior Manager , Development to Launch Analytics** **Working with Us** ... questions and drive business strategy using advanced data science and analytics.** **The Senior Manager , Development to Launch Analytics will join a dynamic and… 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 ... of regulatory submissions for OPDC R&D products. Performs quality reviews of CMC sections of regulatory submissions. + Authors and maintains Standard Operating… 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
- Takeda Pharmaceuticals (Lexington, MA)
- …stakeholders (internal and external) to ensure timely implementation of project objectives. Identify interdependencies and connections between departments and ensure ... structure. + Demonstrate an understanding of company priorities, objectives and project timelines. Define and manage critical path, proactively identify and escalate… more
- Takeda Pharmaceuticals (Boston, MA)
- …into issues and develops contingency plans; communicates timely and proactively project -related issues to senior executive management and manages issues ... and empower you to shine? Join us as a Senior Director, Global Program Leader - Oncology, Solid Tumors...through the functional sub-teams leaders and their teams all project deliverables achieve defined project scope &… 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, they will support to deliver on aligned brand strategy and Global… more
- GE Aerospace (Lynn, MA)
- **Job Description Summary** The Engineering Manager - Ceramic Matrix Composites Design Sub-Section, Defense & Systems Mechanical Sciences, is responsible for ... related to the successful execution of Ceramic Matrix Composites ( CMC ) component design across all Defense and Systems programs....products + Manages a small to medium team of senior professionals as well as others. Requires specialized knowledge… more