- 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 strategies within ... 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 project or act as main… more
- Novo Nordisk Inc. (Boulder, CO)
- …reporting, & overall first level of project guidance. Relationships Reports into Director , CMC Program Development. Essential Functions Project Management Lead ... 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
- Merck & Co. (North Wales, PA)
- Job DescriptionUnder general supervision of an Executive Director /Senior Director , the Principal Scientist / Director is responsible for developing and ... implementing Chemistry, Manufacturing, and Controls ( CMC ) regulatory strategies for our organization's biologics product franchises in accordance with domestic and… more
- Novo Nordisk Inc. (Boulder, CO)
- …raw materials and API candidates in our portfolio. Relationships Reports to Senior Director , Chemical Development (within the CMC team). Essential Functions The ... 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
- Merck & Co. (Rahway, NJ)
- …a range of modalities including small molecules and peptides.- Within OFS, the Director will influence the strategy, lead activities, and develop a team whose roles ... organizations (Research Division/Manufacturing Division), such as Analytical, Quality, Regulatory CMC , and technical functions, to ensure timebound progression of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …(mAb, Drug Substance, Drug Product, or New Modality) manufacturing, evaluates CMC risks for appropriate escalation, recommends transition milestones and ensures a ... manufacturing plans at the site which are aligned with cross-functional CMC strategic discussions. Manage timelines, deliverables, and coordinate the input of… 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
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma. Legend Biotech is seeking Associate Director , Global Strategy & Investigations Owner/Lead as part of the Technical Operations ... science, or related field. Minimum 8+ years of industrial biologics CMC development or manufacturing experience, CAR-T experience is highly desirable. Extensive… more
- Insmed Incorporated (Bridgewater, NJ)
- …Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Senior 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
- 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
- Merck & Co. (Rahway, NJ)
- …experience developing staffFluency in the clinical quality management system and CMC process, across modalities and inclusive of facility/technology development and ... qualificationEffective communication and collaboration skills, with a diverse group of stakeholders both inside and outside FLExDemonstrated project management skillsCritical Behavioral and Leadership CompetenciesCultivates cross-functional collaboration,… 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
- Merck & Co. (North Wales, PA)
- …compliant and support approval of new modality regulatory filings.our Technical CMC teams for end-to-end Quality oversight/support of New Modalities products.Support ... development of and report quality metrics measuring operational effectiveness to appropriate governance forums.Ensure continuous improvement to New Modalities QMS to maintain GMP and Regulatory compliance.Stay ahead of current GMP requirements and industry… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- Position Summary The Director of Project Management will lead a team of project management professionals ensure projects are executed effectively and efficiently ... life sciences manufacturing processes, cGMP practices, regulatory health authority CMC requirementsExperience with federal subsidy programs and government regulationsStrong… 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
- 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
- Option Care Health (Trenton, NJ)
- …developing, and retaining a diverse workforce. Job Description Summary:The Regional Director , Operations is responsible for delivering safe, efficient and effective ... all operational aspects in multiple Option Care Health Care Management Centers ( CMC ) while meeting all corporate compliance and other established rules and… more
- Amicus Therapeutics (Marlow, OK)
- Associate Director CMC RA Location Marlow, UK Requisition ID 2246 # of openings 1 Apply Now ... (https://phh.tbe.taleo.net/phh04/ats/careers/v2/applyRequisition?org=AMICUS&cws=37&rid=1290) Job Brief Associate Director CMC RA Amicus Therapeutics is a global,… more
- Lilly (Indianapolis, IN)
- …are determined to make life better for people around the world. **Associate Director ** **; CMC , Device Development Program Manager** **Functional Area: Technical ... collaborates across multiple functions to arrive at a comprehensive CMC development plan. This is a highly visible and...extensively with line function heads and team members within CMC , Program Team members, and Akouos leadership. **Duties and… 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
