- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and immune disorders. Summary CMC Lead is responsible for supporting the overall CMC strategies within projects, and manage project teams. The project ... 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
- 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 ... portfolio biologics and determines filing strategies, provides expertise as regulatory CMC representative to project teams, and supports change implementation.… 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, ... lead presentations and facilitate site visitsWork closely and collaboratively with Project Management, Quality, Technical Operations, R&D and other relevant groups… 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
- Lilly (Indianapolis, IN)
- …people who are determined to make life better for people around the world. ** Associate Director ** **; CMC , Device Development Program Manager** **Functional ... and device team members, program teams and functional leads. + Provide CMC Project Management for both internal and external CMC development 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...cultivating vendor relationships + Supervising third-party activities and delivering project updates with recommendations Traits we believe make a… more
- Merck (North Wales, PA)
- … Management Office (PMO), and Administrative Professionals. **Position Description/Summary:** The GPAM Associate Director , Project Manager, is a core member ... and realize its full potential. The Associate Director is expected to provide project management...from diverse disciplines (eg, clinical, regulatory, market access, manufacturing, CMC , commercial, and other areas) as applicable to the… more
- CSL Behring (King Of Prussia, PA)
- …position is located in our King of Prussia PA office. It is a Hybrid role. The Associate Director , R&D Project Planning Capability Lead, is a member of CSL ... treat serious and often rare conditions. Could you be our next Associate Director , R&D Master Scheduling Lead? This...R&D's Project and Portfolio Operations… 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...**Job Duties and Responsibilities** + Represent QC on cross-functional project teams. + Provide quality management oversight of analytical… more
- Merck (Boston, MA)
- …and the operational/executional arms within the business. The Program Clinical Supplies Project Manager (Program CSPM) serves as the primary program-level GCS point ... as well as supply chain documentation to support critical CMC activities. + Support the collection of clinical supply...Skills:** + At least 6 years of experience in project management. + At least 3 years of experience… 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...Project Team (CPT), Clinical Development Team (CDT), and CMC Team to ensure successful planning and execution of… 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, ... at CROs. Additional analysis support of non-clinical / biomarker / CMC data and derive insight to contribute to Ascendis'...scientific rigor and internal consistency. + Collaborate with the project team on trial execution. + Support the need… 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
- 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
- Gilead Sciences, Inc. (Foster City, CA)
- …than 35 countries worldwide, with headquarters in Foster City, California. ** Associate Director , Strategic Sourcing and Supplier Management, Primary Packaging ... Components** **KEY RESPONSIBILITIES** The Associate Director , Strategic Sourcing & Supplier Management,...high complexity + Communicates issues to line manager and project teams in a timely manner + Support product… more
- Sanofi Group (Bridgewater, NJ)
- …methodologies as appropriate + Contributes to the development of Global Regulatory Project Strategy (GRPS) and ensures alignment with the core product labeling for ... strategy in collaboration with non-US - non-EU regions / GRA- CMC / GRA-Devices. Attends HA meetings and collaborates with...sub team to ensure NDA/BLA/ MAA/Extensions filings meet the project timelines for product launch and is responsible for… more
- Sanofi Group (Bridgewater, NJ)
- …methodologies as appropriate + Contributes to the development of Global Regulatory Project Strategy (GRPS) and ensures alignment with the core product labeling for ... strategy in collaboration with non-US - non-EU regions / GRA- CMC / GRA-Devices. Attends HA meetings and collaborates with...sub team to ensure NDA/BLA/ MAA/Extensions filings meet the project timelines for product launch and is responsible for… more
