- 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)
- Provide CMC regulatory strategy input and expertise in the area of investigational, new and marketed biologic and small molecule drug products to assigned project ... **Job Description** + Anticipate and develop strategies and/or contingency plans for CMC related scenarios in the areas of biologic/small molecule drug substances,… more
- WuXi AppTec (Boston, MA)
- …drug). We greatly simplify the TIDES drug development by providing all discovery, CMC development, and the entire manufacturing supply chain under one roof. **Please ... of relevant pharmaceutical or biotech industry experience in discovery chemistry, CMC process development and/or GMP manufacturing. + Working knowledge and… more
- Sanofi Group (Cambridge, MA)
- **Job title** : Digital Product Owner (Associate Director/ Senior Manager ) In Silico CMC **Location:** Cambridge, MA, Framingham, MA or Morristown NJ **About ... us get new medicines to patients faster and more efficiently. As an Associate Director/ Senior Manager Product Owner for in silico CMC , you will join a… more
- WuXi AppTec (Boston, MA)
- **Overview** ** Senior Manager Project Management, TIDES Discovery** **Area of focus: Discovery or medicinal chemistry** **Job Location: Remote USA with 10% ... simplify the TIDES drug development by providing all discovery, CMC development and the entire manufacturing supply chain under...+ Work closely with team members across all Discovery, CMC related business units and with the WuXi-TIDES management… more
- Sumitomo Pharma (Boston, MA)
- …. **Job Overview** We are currently seeking a versatile and experienced Senior Manager - Associate Director level scientist with strengths in ... of drug metabolism and bioanalytic chemistry. This position will report to Senior Director of Clinical Pharmacology and Drug Metabolism. S/he will work across… 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
- WuXi AppTec (Boston, MA)
- …oligo and peptide discovery business along with cultivating these relationships into CMC for IND enable studies with our manufacturing (CDMO) business. The candidate ... will work within the North America discovery business development team to pursue new business leads in addition to follow ups on critical issues and aid in resolving customer inquiries. **Responsibilities** + Hunting and Prospecting for oligo and peptide new… more
- Takeda Pharmaceuticals (Boston, MA)
- …company that will inspire you and empower you to shine? Join us as a Senior Director, Global Program Leader (GPL) in our Cambridge office. At Takeda, we are ... on the sub-team objectives. + Accountable with the responsible Global Program Manager for activities operating budgets within the global program; leads budget… more
- Takeda Pharmaceuticals (Lexington, MA)
- …on issues and focus on effective contingencies; interfacing with senior management and influencing decision-making, monitoring slippage and developing strategies ... manage individual study budgets and communicates status to appropriate TA project manager ; and execute communication and change management plans. + Represents and… more
- Takeda Pharmaceuticals (Boston, MA)
- …the GPL on the sub-team objectives. + Accountable with the Global Program Manager for operating budgets within the global program; leads budget setting in ... sub-teams, such as the Clinical Subteam, Commercial Subteam, Pharmaceutical Sciences ( CMC ) Subteam, etc. to the GPT through function-based subteam leaders to… more