- WuXi AppTec (Boston, MA)
- …STA Pharmaceutical, a WuXi AppTec Company, has an exciting opportunity for a ** Manager / Senior Manager , CMC Project Management.** This position ... will be responsible for managing DS and DP projects within STA. The 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 team. The… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- **Job Summary** The Chemistry, Manufacturing and Controls ( CMC ) Global Regulatory Affairs (GRA) professional is responsible for developing and executing global ... regulatory strategies for CMC aspects of small molecule products during late-stage development and throughout the commercial lifecycle. This includes initial… more
- Takeda Pharmaceuticals (Lexington, MA)
- …to reduce COGs and strengthen supply reliability. + Collaborate closely with an assigned CMC Project Manager (who will provide you PM support). + Continuous ... Description** **About the role** Join us as our **Global Manufacturing Sciences CMC Lead** and drive **high-impact, high-visibility CMC projects for innovative… 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 ... large and diverse commercial biologics portfolio. In this role, you will be a senior subject matter expert across one or more products and provide strong technical… 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
- Takeda Pharmaceuticals (Lexington, MA)
- …5+ years of experience + Must have exceptional working knowledge of CMC operations relating to research and development and investigational drug manufacturing. Must ... have direct management experience with external contract manufacturing organizations. + Demonstrated excellence in project management and effectively managing multiple projects/priorities. + Act as the key contributor in authoring Statements of Work in and… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …with members of the global regulatory team (GRL, regional leads, CMC -RA, labeling, medical writing, regulatory operations, etc.) to develop global regulatory ... plans, address global regulatory issues, health authority queries, and regulatory obligations. - Authors, coordinates, reviews, and executes submissions and responses to regulatory authorities related to INDs, amendments, supplements, aggregate reports, NDAs… more
- Takeda Pharmaceuticals (Boston, MA)
- …to the best of my knowledge. **Job Description** **About the role** This senior individual contributor role in Global Manufacturing Science (GMSci) is the subject ... collaboration during troubleshooting and optimization. + Author and/or review key CMC and quality deliverables, such as: + protocols, validation reports, methods,… more
- Takeda Pharmaceuticals (Lexington, MA)
- …**Job Description** **Title: Global Manufacturing Sciences BioProcess Lead (Sr. Manager )** **Location: Zurich, Switzerland / Lexington, MA** **About the role:** ... large and diverse commercial biologics portfolio. You will act as a senior subject matter expert across the biologics portfolio and provide technical expertise… 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
- Takeda Pharmaceuticals (Boston, MA)
- …company that will inspire you and empower you to shine? Join us as a Senior Director, Global Program Leader - Oncology, Solid Tumors in our Cambridge office. At ... 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 (Devens, MA)
- …commercial products. This role is responsible for developing and executing the CMC strategy for assigned products, managing key technical risks, and ensuring ... alignment with stakeholders. As a key member of the CMC and Global Operations (GO) Team, they will support...team building and communication skills. + Ability to influence senior stakeholders and align cross-functional teams on complex technical… more
- Sanofi Group (Waltham, MA)
- …Functional Planner, Project Manager , CROs, etc.) + Under supervision of the senior manager of the TED team or Research lead, participates in project ... 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
- Bristol Myers Squibb (Devens, MA)
- …T he individual will provide technical expertise and leadership to Product CMC /Quality Teams to develop, implement, and manage the strategies for Quality to ... functions. + Supports the overall product quality strategy based on CMC deliverables, technical team objectives, life-cycle improvements, and regulatory commitments.… more