- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …well as other research areas centered around rare diseases and immune disorders. **Summary** CMC Lead is responsible for supporting the overall CMC ... based on the project needs and the respective development stage of the project. The CMC Lead will support the Sr. CMC Lead on complex and/or late-stage… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Join Gilead and help create possible, together. **Job Description** We are seeking an Associate Director , Regulatory Affairs CMC candidate to sit at our ... Foster City, CA site. **Responsibilities:** + The CMC Regulatory Affairs Associate Director ...which there may not be clear/specific regulatory guidance + Lead the preparation of risk assessments on major global… more
- Lilly (Indianapolis, IN)
- …are determined to make life better for people around the world. **Purpose:** The Senior Director of Global Regulatory Affairs - CMC (GRA- CMC ) leads and ... changes in the external environment. + Utilizes scientific and regulatory knowledge to lead preparation, review, and finalization of CMC documents for global… more
- WuXi AppTec (Cranbury, NJ)
- …drug). We greatly simplify the TIDES drug development by providing all discovery, CMC development, and the entire manufacturing supply chain under one roof. **Please ... require bilingual language skills in Mandarin and English. **Responsibilities** + Lead all project initiation and planning efforts. Participate in the implementation… more
- Merck (North Wales, PA)
- **Job Description** This Associate Principal Scientist position is equivalent to an Associate Director position. Under direction from a Director , the ... for commercial or new products such as pre-filled syringes and autoinjectors. The Associate Principal Scientist will lead the development and the implementation… 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 ... faster and more efficiently. As an Associate Director /Senior Manager Product Owner for in silico CMC...**Main Responsibilities:** + Implement digital product strategies for specific CMC areas, aligning with broader roadmaps. + Lead… more
- Merck (West Point, PA)
- **Job Description** We are seeking a highly motivated individual for the role of Associate Director , Biologics Drug Substance Lead within the Enterprise Go ... Chain. The end-to-end scope includes Drug Substance for all large molecules. The Associate Director is expected to contribute to ongoing business process… more
- AbbVie (Worcester, MA)
- …drug substance within Product Development Science and Technology. Responsibilities: + Lead implementation of work processes to eliminate manual data manipulation and ... engineers, and statisticians to define data flows within the CMC organization. o Partner closely with Abbvie Business Data...o Partner closely with Quality Assurance to ensure Biologics CMC data integrity practices are best in class. +… more
- Sanofi Group (Morristown, NJ)
- **Job title** : GRA Device Lead ( Associate Director ) **Location:** Cambridge. MA **,** Morristown, NJ **About the Job** Are you ready to shape the future of ... of products. The team is part of the Global Regulatory Affairs, Regulatory CMC and Device Department within Global Research and Development. The selected candidate… more
- Otsuka America Pharmaceutical Inc. (Rockville, MD)
- **Job Summary** Associate Director , Quality Control, Biologics is responsible for late development stage through commercial biologic products including product ... scientific disciplines to drive programs through critical milestones. Collaborate with CMC teams and demonstrating ability to understand and communicate impact of… more