- Merck & Co. (Rahway, NJ)
- …while developing and expanding your career.The Chemistry, Manufacturing & Controls ( CMC ) Pre-approval Pharm Executive Director is accountable for managing ... are compliant and available to patients in markets as needed.-The Executive Director of CMC Pre-approval Pharm holds responsibility for overseeing a team of … more
- 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
- 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
- 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
- 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)
- …as other research areas centered around rare diseases and immune disorders.Summary The Director , Global eQMS Management QA GMP, reports to the Senior Director , ... Global Quality and GMP related functions (Supply Chain, Regulatory Affairs, CMC , Pharmaceutical Technology) who are either direct or downstream users/consumers of… more
- Merck & Co. (North Wales, PA)
- …Office (PMO), and Administrative Professionals.- Position Description/Summary: The GPAM Associate Director , Project Manager, is a core member of Early Drug ... progress the R&D pipeline and realize its full potential. The Associate Director is expected to provide project management leadership and drive cross-functional… 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
- 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
- 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
- Citizens Medical Center (Victoria, TX)
- …modality certifications, under the direction of a radiologist and / or the Director of Radiology, performs radiographic procedures at a technical level not requiring ... then you could be a good fit for the CMC team!BENEFIT OFFERINGSHealthMedical, Dental, VisionSTD, LTD DisabilitySupplemental Life, AD&DFlexible Spending… more
- Gilead Sciences, Inc. (Foster City, CA)
- …in more than 35 countries worldwide, with headquarters in Foster City, California. ** Director , CMC Regulatory Affairs - Biologics** **KEY RESPONSIBILITIES** The ... Director , CMC Regulatory Affairs for Biologics is responsible for defining...position will ensure "right first time" global approvals of CMC regulatory (Biologics) submissions, and "right to operate" by… 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
- 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
- Merck (Rahway, NJ)
- …while developing and expanding your career. The Chemistry, Manufacturing & Controls ( CMC ) Pre-approval Pharm Executive Director is accountable for managing a ... compliant and available to patients in markets as needed. The Executive Director of CMC Pre-approval Pharm holds responsibility for overseeing a team of CMC… more
