- Takeda Pharmaceuticals (Lexington, MA)
- …**How You Will Contribute** Reporting to Head of GMSci Bio Program Management, you + Co- lead CMC project teams for complex biologic products and guide ... my knowledge. **Job Description** **About the role** Join us as our ** CMC Sr. Project Lead ** , **_Global Biologics Manufacturing Sciences_** _(GMsci Bio)_… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …interpretation of regulatory guidelines and perspective to the cross-functional team. Serve as CMC regulatory lead on global project teams (Pharmaceutical ... to Health Authority questions and deficiency letters. + Represents CMC RA in project team meetings and... CMC related matters. Prepare briefing packages and lead CMC discussions during regulatory interactions as… more
- 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 ... projects and data types. **POSITION ACCOUNTABILITIES:** + Contribute to and/or serve as lead representing data science function on project teams in support of… more
- Takeda Pharmaceuticals (Lexington, MA)
- …**Job Description** **About the role** Join us as our **Global Manufacturing Sciences CMC Lead ** and drive **high-impact, high-visibility CMC projects for ... edge of process technology. In this role, you will lead cross‑functional CMC teams, represent Global Manufacturing...strengthen supply reliability. + Collaborate closely with an assigned CMC Project Manager (who will provide you… more
- Merck (Boston, MA)
- …+ **Stakeholder Management & Communication** : The analyst will organize and lead information gathering sessions with the internal CMC community, collaborate ... Under the guidance of dCMC Regulatory Authoring Leadership, the Senior Specialist, Regulatory Authoring Business Analyst, will optimize regulatory authoring… 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 ... own analytical comparability strategies and non‑GMP analytical methods for assigned products. + Lead preparation and review of CMC dossier sections related to… more
- Takeda Pharmaceuticals (Boston, MA)
- …**_Objective / Purpose:_** The Head of Design & Delivery, PharmSci will lead the global digital product strategy across Takeda's Pharmaceutical Sciences Digital Data ... & Technology (DDT) portfolio driving innovation and operational excellence across the CMC lifecycle. This leadership role is accountable for shaping and delivering… more
- Takeda Pharmaceuticals (Boston, MA)
- …to increase business performance, organizational efficiency while increase speed for CMC deliverables, including AI-forward projects and mindset. + Partner with PS, ... partners and leadership to identify, prioritize, and lead enterprise-wide transformation initiatives, with a focus on... enterprise-wide transformation initiatives, with a focus on increasing CMC productivity of a minimum 5% per year and… 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
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …activities for all assigned projects in alignment with the Global Regulatory Lead . Translates complex pertinent global requirements and provides an assessment of the ... associated regulatory challenges to the GRL, global regulatory team, assigned project teams, and internal/external functional business units as needed. Works… more