- Daiichi Sankyo, Inc. (Bernards, NJ)
- …8-10 years pharmaceutical industry experience with 4+ years direct or related CMC regulatory experience orPhD. with 6-8 years pharmaceutical industry experience ... medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of...and 4+ years direct or related CMC regulatory experienceSuccessful track record in preparation,… more
- Formation Bio (New York, NY)
- … leaders.Responsibilities Strategic Leadership Develop and execute comprehensive CMC strategies for pre-clinical, clinical, and commercial-stage biologic products, ... & External Partnerships Partner closely with analytical development, manufacturing, quality, and regulatory teams to ensure seamless execution of CMC plans.… more
- Merck & Co. (Rahway, NJ)
- …are our Inventors. Through innovative thinking, state-of-the-art facilities, cutting-edge science , and technology, we collaborate to deliver the next medical ... to join Biologics Process Research & Development (BPR&D) as a Senior Principal Scientist.BPR&D within Research Laboratories is committed to rapidly delivering… more
- Merck & Co. (Rahway, NJ)
- …Immunochemistry, People Leadership, Pharmaceutical Development, Pharmaceutical Formulations, Pharmaceutical Sciences , Product Development, Regulatory CMC , ... opportunity is fast paced and contributes to the Pharmaceutical Sciences and Clinical Supplies (PSCS) deliverable which is the...our Research & Development Division ) such as Quality, Regulatory CMC , and technical functions, to ensure… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …preferredExtensive knowledge in process development, technology transfer, process comparability, CMC regulatory guidelines, process monitoring and manufacturing ... reduction efforts worldwide.Key Responsibilities Represent MSAT at joint technical and CMC committeesPartner closely with senior Janssen technical team to… more
- Merck & Co. (Rahway, NJ)
- …Scientists are our Inventors. Using innovative thinking, state-of-the-art facilities, cutting-edge science , and technology, we partner to deliver the next medical ... different stages of clinical development, 2) process characterization and regulatory filings for successful commercializationAdvance upstream processes by improving… more
- Merck & Co. (Rahway, NJ)
- …Scientists are our Inventors. Using innovative thinking, state-of-the-art facilities, cutting-edge science , and technology , we partner to deliver the next medical ... , shape and realize innovation across the Biologics ' pipeline, strategy, and science - Advance the pipeline by c ollaborat ing with cross-functional teams, from… more
- Merck & Co. (Rahway, NJ)
- …functions including Global Science Engineering and Commercialization (GSEC), Quality, and CMC Regulatory Affairs, as well as, the GBO Leadership Team (LT). ... commercializing and supplying more products than ever before.Reporting directly to the Senior Vice President (SVP) of Global Biologics Operations, the Head of Global… more
- Merck & Co. (Rahway, NJ)
- …interacting with other teams within BPD and staff in Process Cell Science , US Operations, Clinical Manufacturing, and Commercial Manufacturing groups. The candidate ... should be capable of leading a cross-functional CMC team and is expected to be adept in...tech transfer of clinical or/and commercial processes, and pertinent regulatory filings. The incumbent will be responsible for recruiting,… more
- Eli Lilly and Company (Indianapolis, IN)
- … Regulatory Affairs - CMC commercial solid oral products will use CMC technical knowledge and regulatory science expertise to drive regulatory ... science and manufacturing processes. Knowledge of global CMC regulatory requirements and guidelines for reporting... Sciences , Biology, or similar. 5+ years of Regulatory CMC experience and/or equivalent (such as… more
- Katalyst HealthCares and Life Sciences (Tarrytown, NY)
- …sites, when required. Provide guidance and advise management regarding improvement in CMC harmonization process of regulatory documentation at all manufacturing ... pending and approved applications. Lead, guide, and train the CMC team to ensure highly qualified personnel that can...of PLAIR activities, prior to new product launch. Manage regulatory correspondence mainly to CDER, FDA, User fee staff,… more
- nChroma Bio (Boston, MA)
- …regulations related to QC. The candidate's ability to represent the AD/QC function in Regulatory CMC meetings and drafting the Module 3/IB documents is a must. ... troubleshooting. *Author QC related SOPs, CAPAs and Change Controls. *Work with CMC Regulatory for authoring/coordinating and updating clinical and commercial… more
- Vaxcyte (San Carlos, CA)
- …and ensure safety and compliance of validation activities including support for regulatory filing, inspection, and other CMC and technology team activities. ... report on key risk indicators and risk events, providing regular updates to senior management. Ensure compliance with regulatory requirements and industry best… more
- Takeda Pharmaceutical Company Limited (Lexington, MA)
- …in leading cross-functional clinical programs within Medical Affairs, Clinical Research, Regulatory , CMC or other drug development related function. Clinical ... with significant experience within related functions (eg, Medical Affairs, Clinical Operations, Regulatory , CMC , Marketing). Minimum of 5 years' experience as a… more
- Neurocrine Biosciences, Inc. (San Diego, CA)
- …project teams (including clinical operations, preclinical/clinical pharmacology, biometrics, regulatory , drug safety, CMC ). Responsible for medical ... the burden of debilitating diseases and disorders because you deserve brave science . For more information, visit neurocrine.com, and follow the company on LinkedIn,… more
- Arxada (Williamsport, PA)
- Senior Production Process Engineer-Williamsport, PA Arxada is a global specialty chemicals business that's committed to solving the world's toughest preservation ... challenges through better science . [With a proud history of innovation dating back...of cleaner, greener solutions. We are looking for a Senior Production/Process Engineer in Williamsport, PA. The function of… more
- Bristol Myers Squibb (Indianapolis, IN)
- …the global leader in radiopharmaceuticals . We are seeking an experienced and motivated ** Senior Director, Regulatory Affairs - CMC (Manufacturing)** . This ... Regulatory Affairs and will oversee and/or manage CMC regulatory functions within the RayzeBio manufacturing...single vision as inspiring as Transforming patients' lives through science (TM) , every BMS employee plays an integral… more
- Lilly (Indianapolis, IN)
- …regulatory sciences leadership, decision making, guidance and coaching for CMC regulatory scientists. + Communicates regulatory decisions and strategy ... world. **Purpose:** The Senior Director of Global Regulatory Affairs - CMC (GRA- CMC )...or PhD in Chemistry, Biology, Engineering, or closely related science + 10+ years of experience in CMC… more
- Lilly (Indianapolis, IN)
- …in Global Regulatory Affairs - CMC Commercial Products will leverage CMC technical knowledge and regulatory science expertise to drive regulatory ... around the world. Lilly is looking for post approval regulatory CMC scientists to join us in...+ Deep technical knowledge of synthetic molecule drug substance CMC science and manufacturing processes for conventional… more
- Boehringer Ingelheim (Ridgefield, CT)
- …complexity and/or business impact. The Senior Associate Director, US Product CMC Regulatory Affairs is responsible for the direction, coordination and ... and competitive advantage lie with our people. The Associate Director, US Product CMC Regulatory Affairs is responsible for the coordination and execution of… more
