- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …product quality and stakeholder satisfactions. Responsible to communicate and escalate to Senior CMC Lead regarding the activity status and potential critical ... to lead teams within overall CMC development project(s), to support Sr CMC Lead. In case no Sr CMC Lead is established, take main responsibility for … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders.Summary The Associate Director , RACMC Portfolio Products, will be responsible for regulatory CMC ... for working on cross-functional teams, developing and executing post-approval Regulatory CMC strategies, reviewing CMC information and data, authoring … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and Oncology, incl. coordinating Reg Intelligence & Policy activities with the Regulatory- CMC function and corporate affairs as needed. In the short term, the ... with DS' strategic objectivesWork with other DS functions (incl. Regulatory- CMC ) to coordinate Regulatory Intelligence activities and ensure regulatory/development… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking a Senior Manager/Associate Director , External Manufacture as part of the Global ... overseeing the project, driving the deliverables, managing the risks, and updating the senior leadership and stakeholders on the status and plans. This position will… more
- Insmed Incorporated (Bridgewater, NJ)
- …Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Director , Toxicology, is a key member of the nonclinical safety team, reporting ... to the Executive Director , Head of Toxicology and Molecular Mechanisms. In this...subject matter experts in discovery, bioanalysis, pharmacokinetics, clinical development, CMC , and program management to drive the overall development… more
- Novo Nordisk Inc. (Boulder, CO)
- …and API candidates in our portfolio. Relationships Reports to Senior Director , Chemical Development (within the CMC team). Essential Functions The successful ... the Department The Boulder Site is home to the specialized technical operations/ CMC team for oligonucleotides and RNAi therapeutics, continuing its legacy as the… more
- Novo Nordisk Inc. (Boulder, CO)
- …the Department The Boulder Site is home to the specialized technical operations/ CMC team for oligonucleotides and RNAi therapeutics, continuing its legacy as the ... laboratory completed in 2021 to support analytical and process development, the CMC team works alongside Quality, Regulatory, Technical Operations and RNAi Early… more
- FUJIFILM Holdings America Corporation (Boston, MA)
- …scientific degree and/or MBA preferredPrevious role as Business Development Manager, Sr . Business Development Manager or Director of Business Development10 ... Overview The Associate Director / Director of Business Development, will be...promote FCDI's CDMO offeringsCoordinate sales calls with C-level and senior leaders at client accounts; prepare and lead presentations… more
- Lilly (Philadelphia, PA)
- …cost targets. + Collaborate with cross-functional team leaders, including development, CMC regulatory, manufacturing, and supply chain teams, to ensure seamless ... execution of CMC strategies and activities. + Lead and direct the...budget, and resource allocation, and provide regular updates to senior management. + Lead other tasks / projects as… more
- Frontier Medicines (Boston, MA)
- Join Frontier Medicines on an exciting journey as our newest Senior Manager/Associate Director in CMC Development, located at either our Boston or South San ... of our team, reporting directly to the Head of CMC , you'll play an integral role in advancing our...of API and preclinical formulations + Fostering collaboration with CMC and Discovery R&D teams + Conducting development studies,… more
- Teva Pharmaceuticals (West Chester, PA)
- Senior Director , Regulatory Affairs CMC , Innovative Medicine (Hybrid) Date: Apr 26, 2024 Location: West Chester, United States, Pennsylvania, 19380 Company: ... difference, and new people to make a difference with. **The opportunity** The Senior Director , Regulatory Affairs CMC is responsible to manage and help… more
- Lilly (Indianapolis, IN)
- …determined to make life better for people around the world. ** Senior Advisor/ Director , Global Regulatory Affairs - CMC , Small Molecules** At Eli Lilly, we ... new medicines to patients who need them all over the world. The Senior Advisor/ Director in Global Regulatory Affairs - CMC Small Molecules will leverage… more
- Lilly (Indianapolis, IN)
- …the world. Lilly is looking for regulatory Chemistry, Manufacturing and Control ( CMC ) scientists to join us in developing and bringing life-changing new medicines ... the project leader, you will be expected to collaborate with the broader CMC team to provide strategic, tactical, and operational support for market registrations… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …product quality and stakeholder satisfactions. Responsible to communicate and escalate to Senior CMC Lead regarding the activity status and potential critical ... to lead teams within overall CMC development project(s), to support Sr CMC Lead. In case no Sr CMC Lead is established, take main responsibility for … more
- Takeda Pharmaceuticals (Boston, MA)
- …in order to bring life-changing therapies to patients worldwide. Join Takeda as a Director , GRA CMC Pharmaceuticals, Oligonucleotides where you will lead the GRA ... CMC Pharmaceuticals, Oligonucleotides team, you will report to the Executive Director and Head, CMC Regulatory Affairs, Pharmaceuticals. **How you will… more
- Bristol Myers Squibb (Madison, NJ)
- …work and in their personal lives. Read more: careers.bms.com/working-with-us . Sr . Director , Statistical Programming provides technical leadership to portfolio ... delivery and building / retaining highly skilled talent in Statistical Programming. Sr . Director , Stats Programming, proactively creates and implements delivery… more
- Lilly (Indianapolis, IN)
- …make life better for people around the world. **Purpose** : The purpose of the Sr . Director role in Global Regulatory Affairs (GRA) - Drug Delivery and Digital ... clinical trials and market clearance/registrations. It is necessary for the Director to develop collegial and mutually productive relationships across Lilly, partner… more
- Teva Pharmaceuticals (Parsippany, NJ)
- Sr Director , Global Launch Readiness - Immunology Date: Apr 26, 2024 Location: Parsippany, United States, New Jersey, 07054 Company: Teva Pharmaceuticals Job Id: ... messaging, positioning, creative campaign development and regional alignment/coordination). The Senior Director , Global Launch Readiness Immunology will be… more
- Lilly (Cambridge, MA)
- …significant improvements in healthy outcomes for our customers. We are seeking an Executive/ Senior Director - DDCS Drug Delivery and New Product Innovation to ... Preferences:** + Demonstrated scientific knowledge of Pharmaceutical Drug Discovery, CMC , Clinical Development, and Intellectual Property Processes. + Experience… more
- Gilead Sciences, Inc. (Foster City, CA)
- …in more than 35 countries worldwide, with headquarters in Foster City, California._ ** Senior Director - Analytical Regulatory Science** KEY RESPONSIBILITIES The ... Sr Director , Analytical Regulatory Science, is responsible for supervising a...incumbent will support "right first time" global approvals for CMC control strategies and maintain "right to operate" throughout… more
