- 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
- 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)
- …other research areas centered around rare diseases and immune disorders.Summary The Associate Director , RACMC Portfolio Products, will be responsible for ... regulatory CMC (Chemistry, Manufacturing, and Controls) activities of the portfolio...working on cross-functional teams, developing and executing post-approval Regulatory CMC strategies, reviewing CMC information and data,… more
- Merck & Co. (North Wales, PA)
- …Management Office (PMO), and Administrative Professionals.- Position Description/Summary: The GPAM Associate Director , Project Manager, is a core member of ... the R&D pipeline and realize its full potential. The Associate Director is expected to provide project...from diverse disciplines (eg, clinical, regulatory, market access, manufacturing, CMC , commercial, and other areas) as applicable to 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
- Novo Nordisk Inc. (Boulder, CO)
- …quality, cost & timely completion of all validation deliverables. Relationships Associate Director . Essential Functions Perform, review & approve ... 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
- FUJIFILM Holdings America Corporation (Boston, MA)
- Overview The Associate Director / Director of Business Development, will be an ambitious salesperson who independently works to identify, qualify, negotiate, ... role as Business Development Manager, Sr. Business Development Manager or Director of Business Development10 years or more of relevant combined commercial… 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… 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
- Sumitomo Pharma (Columbus, OH)
- …and management of the global contract testing laboratories in partnership with the Company's CMC Team. The Associate Director also participates in drafting ... ** Associate Director , GMP Quality Control** Sumitomo...release, change control and facility re-starts. + Partners with CMC to conduct method transfers and validation of new… more
- Emory Healthcare/Emory University (Atlanta, GA)
- …academic community. **Description** The Goizueta Business School is in search of an Associate Director - Graduate Student Advising and Programming to join the ... Center team. This position will report to the Executive Director at the Goizueta Business School. JOB DESCRIPTION: +...across each program served by the Career Management Center ( CMC ). + Develops the overall student advising strategy and… more
- Teva Pharmaceuticals (West Chester, PA)
- Associate Director , Regulatory Affairs - West Chester, PA Date: Mar 26, 2024 Location: West Chester, United States, 1938 Company: Teva Pharmaceuticals Job Id: ... difference with. **How you'll spend your day** As the Associate Director , Regulatory Affairs you will be...of the regional, clinical and Chemistry Manufacturing and Controls ( CMC ) regulatory strategies with the overall global strategy. In… more
- Ascendis Pharma (Palo Alto, CA)
- …of the business, from drug development to marketing. Position Summary The Associate Director of Biostatistics will provide statistical leadership, oversight, ... and activities at CROs. Additional analysis support of non-clinical / biomarker / CMC data and derive insight to contribute to Ascendis' scientific research may… more
- Novo Nordisk (Watertown, MA)
- …Development - Boston and will work closely with other functions of CMC drug development, including Drug Product, Analytical Sciences, Quality Assurance, and Supply ... substance and resolve technical issues or deviations + Author and review relevant CMC sections for US and ex-US regulatory filings, including NDAs + Work… more
- Sanofi Group (Framingham, MA)
- …Culture Development department within CCD located in Framingham, MA in the role of Associate Director . We are looking for a candidate with excellent scientific, ... CMC , communication, and management skills to manage a team...harvest processes for clinical and commercial manufacturing + Have CMC experience covering FIH to commercial process development, process… more
- Boehringer Ingelheim (North Brunswick, NJ)
- …Ingelheim has a career opportunity developing pharmaceutical products as a Senior Associate Director , Analytical Development. We are looking for an individual ... in development. You will represent the Analytical Development function in the CMC -Technical Development Team whenever needed and pro-actively help the team to… more
- Novo Nordisk (Watertown, MA)
- …The Analytical Sciences and Quality Control group is a core pillar of our dynamic CMC drug development team. This role is critical in development of assets in our ... rare-disease, small molecule portfolio. Relationships Reporting to the Director , Analytical Sciences, this position works closely with other functions in CMC … more
- J&J Family of Companies (Columbus, OH)
- Associate Director , Regulatory Affairs - 2406166277W **Description** Janssen Research & Development, LLC, a member of Johnson & Johnson's Family of Companies, is ... recruiting for an Associate Director , Regulatory Affairs. This position can...alignment with NA regional teams, Chemistry, Manufacturing, and Controls ( CMC ), commercial strategies, and the Target Product Profile. +… more
- Merck (North Wales, PA)
- …Management Office (PMO), and Administrative Professionals. **Position Description/Summary:** The GPAM Associate Director , Project Manager, is a core member of ... the R&D pipeline and realize its full potential. The Associate Director is expected to provide project...from diverse disciplines (eg, clinical, regulatory, market access, manufacturing, CMC , commercial, and other areas) as applicable to the… more
- University of Southern California (Los Angeles, CA)
- cGMP Associate Director Process DevelopmentApply (https://usc.wd5.myworkdayjobs.com/ExternalUSCCareers/job/Los-Angeles-CA Health-Sciences-Campus/cGMP- ... products, in compliance with current Good Manufacturing Practices (cGMP). As the Associate Director of Process Development, the individual will be responsible… more
