- Sanofi Group (Framingham, MA)
- **Job Title:** CMC Project Lead **Location** : Framingham, MA **About the Job** Are you ready to shape the future of medicine? The race is on to speed up ... be critical in helping our teams accelerate progress. Global CMC Project Management is a CMC...with agility & strategic excellence. Our mission is to lead projects of the Sanofi R&D pharma portfolio from… more
- Sanofi Group (Waltham, MA)
- **Job Title:** CMC Project Manager **Location:** Framingham, MA, Waltham, MA **About the Job** Are you ready to shape the future of medicine? The race is on to ... be critical in helping our teams accelerate progress. The CMC Project Manager is a key contributor...feasibility and optimization with Functions representatives and communicate to CMC team + Lead risks assessment &… more
- Takeda Pharmaceuticals (Lexington, MA)
- …regulatory CMC investigational and/or registration strategies for assigned products as GRA CMC Product Lead and/or team lead . Assigned products include ... regulatory requirements and standards. + When in a GRA CMC Product Team lead role, prepares and...within a complex matrix environment in GRA with GRLs, CMC RA project leads and other GRA… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …requirements for CMC and GMP related submissions and inquiries. + Represents CMC RA in project team meetings and provides regulatory guidance and perspective ... to the cross-functional team in conjunction with global regulatory lead (s). + Prepare, coordinate and/or review all CMC and GMP related documents for submission… more
- WuXi AppTec (Boston, MA)
- …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...orderly progression of projects from the proposal stage through project completion by interacting with the client, technical team,… more
- Takeda Pharmaceuticals (Boston, MA)
- …analytics towards enhancing portfolio prioritization, decision-making and delivering on business objectives. Lead the R&D CMC efforts for leveraging digital and ... towards enhancing portfolio prioritization, decision-making and delivering on business objectives. + Lead the CMC efforts for leveraging digital and AI tools… more
- Regeneron Pharmaceuticals (Cambridge, MA)
- …+ Build, lead and mentor the regulatory team and provide project teams with the strategic regulatory guidance to expedite product development, registration and ... will build and oversee Global Regulatory Science and Regulatory CMC strategic framework and will support driving deliverables for...cell transplant. In this position you will build and lead a cell medicine regulatory affairs team and provide… more
- Sanofi Group (Cambridge, MA)
- **Global Project Head -AATD* SAR447537** **Development** The Global Project Head (GPH) is delegated various responsibilities by the Senior GPH and/orTherapeutic ... Area Head to provide leadership, supervision, and coordination within the Global Project Team (GPT). The GPH position requires achieving results through others and… more
- Takeda Pharmaceuticals (Boston, MA)
- …teams and hold teams accountable for deliverables along the entire BD process. + Lead the confidential review and CMC due diligence assessment process to ... and contract review + Create and revise processes to ensure high- functioning project management of CMC Business Development & Licensing activities. Process… more
- Sanofi Group (Cambridge, MA)
- …was possible. Ready to get started? **Main Responsibilities:** + Serve as Device Regulatory Lead on assigned project teams (early phase, late stage and marketed ... **Job Title:** GRA Device Lead **Location** : Morristown, NJ, Cambridge, MA, Framingham,...team is part of the Global Regulatory Affairs, Regulatory CMC and Device Department within Global Research and Development.… more
- Takeda Pharmaceuticals (Lexington, MA)
- …projects, etc. in conjunction with senior staff and global line and function heads + Lead global CMC and Quality key initiatives and represent Pharm Sci to other ... my knowledge. **Job Description** **How you will contribute:** + Lead and develop a global team of managers and...the field of analytical controls and compliance + Global CMC program oversight of Pharmaceutical Sciences (PS) with management… more
- Organon & Co. (Boston, MA)
- …science, data science, clinical operations, regulatory affairs, chemistry, manufacturing and control ( CMC ), project management and other partner groups as part ... in the US + There are **2 openings** The Director, Clinical Pharmacology Lead will be responsible for contributing and/or devising the clinical pharmacology strategy… more
- Sanofi Group (Cambridge, MA)
- …was possible. Ready to get started? **Main Responsibilities:** + Serve as GRA-Devices lead on assigned project teams (early phase, late stage and marketed ... **Job title** : GRA Device Lead (Associate Director) **Location:** Cambridge. MA **,** Morristown,...team is part of the Global Regulatory Affairs, Regulatory CMC and Device Department within Global Research and Development.… more
- Takeda Pharmaceuticals (Lexington, MA)
- …deliverables to comply with medical device and combination device regulations. + Lead project execution activities and oversee the development of statistically ... functions and CMC team. Planning and implementation of solutions to project problem/issues + Coordinates tech transfer with vendors. + Stays updated on related… more
- Takeda Pharmaceuticals (Lexington, MA)
- …and takes on, as needed, non- project responsibilities, which can include project management processes and systems. + Lead and matrix-manage high performing ... Generation, US Medical** **Lexington, MA** **Hybrid** **_OBJECTIVES/PURPOSE:_** Provides clinical project management and leadership to ensure successful operational execution… more
- Merck (Boston, MA)
- …manage program escalations and works with New Product Introduction/Operations lead for business unit operations escalations **Cross-functional relationships** + ... other stakeholders (Research & Development, Commercialization, Tech Ops, Ops, Quality, Analytical Regulatory- CMC , and Supply Chain, etc.) + Ensures that TT team is… more
- Sanofi Group (Cambridge, MA)
- …working closely with analytical chemists, process engineers, pilot plant experts and project managers within the CMC Synthetics organization. + Communicate ... of people. **About the opportunity:** The Process Chemistry team, part of the CMC Synthetics organization within Sanofi R&D, is responsible for the design and… more
- Takeda Pharmaceuticals (Boston, MA)
- …in Research. You will translate high-level digital strategies into actionable project plans, manage cross-functional teams, monitor progress via key performance ... technology teams to drive seamless integration. + Interface with CMC and Research Data Digital &Technology (RDDT) to ensure...the development of a forward-looking Research digital strategy + Lead the creation and implementation of an agile digital… more
- Rhythm Pharmaceuticals (Boston, MA)
- …team in Boston, Massachusetts. The Associate Director will be the technical lead for Drug Product small molecule drug product development, manage outsourced ... Requests for Proposals (RFPs). + Collaborates with internal stakeholders, including CMC Drug Substance, Supply Chain Management, Quality, and Regulatory Affairs. +… more
- Takeda Pharmaceuticals (Boston, MA)
- …to support the process and drive continuous improvements + Establish standard lead times/cycle times from request of ancillary supplies to delivery to patient/site ... clinical supply chain management (preferred), ancillary supply management, planning, CMC development, Clinical Operations or related discipline, experience working… more