- Takeda Pharmaceuticals (Cambridge, MA)
- …innovation-driven 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 of Statistics, you will provide statistical leadership in...design, analysis, and interpretation of Chemicals, Manufacturing, and Controls ( CMC ) study data throughout Pharmaceutical Sciences. We seek an… 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 (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
- 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)
- …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
- 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 ... Paid Time Off + US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ,… 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