- The University of Texas MD Anderson Cancer Center (Boston, MA)
- Job Title: Sr . Project Manager , CMC Operations Job Number: 37087 Location: Boston, MA Job Description Aktis Oncology is seeking a dynamic and ... results-driven Senior Project Manager (SPM) to...processes, and technology to drive strategic outcomes within the CMC Operations organization. The SPM will be responsible for… more
- The University of Texas MD Anderson Cancer Center (Boston, MA)
- …company in Boston is seeking a dynamic Senior Project Manager to support strategic outcomes within CMC Operations. This role involves creating ... project plans, managing budgets, and ensuring project success through stakeholder engagement and risk management. Ideal candidates will have extensive project… more
- argenx SE (Boston, MA)
- …safety strategy in alignment with our stakeholders, present concepts and results to project teams and senior management. All our studies are conducted in ... -related content is correct and comprehensive.* In collaboration with the program manager , ensure correct financial and project planning.* Together with Global… more
- Takeda (Boston, MA)
- …into issues and develops contingency plans; communicates timely and proactively project -related issues to senior executive management and manages issues ... The GPL ensures through the functional sub-teams leaders and their teams all project deliverables achieve defined project scope & objectives, budget and… more
- argenx SE (Boston, MA)
- …multidisciplinary project teams* Present and contribute to discussions at senior management forums* Actively contribute to the development strategy at internal ... -related content is correct and comprehensive.* In collaboration with the program manager , ensure correct financial and project planning.* Provide guidance on… more
- VCLS (Somerville, MA)
- …research, vigilance, regulatory strategy and submissions, chemistry manufacturing and controls ( CMC ), and market access. With 230+ life science professionals across ... and is a critical focus for our future growth. Role Overview As General Manager , US, you will lead VCLS's Life Sciences consulting business across North America,… 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
- 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 (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
- 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
