- 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)
- …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
- MannKind Corporation (Bedford, MA)
- …Lead Pharmacology/PK/PD activities on multiple projects; collaborate with R&D senior management to align scientific approaches with business objectives. Partner ... with clinical and regulatory teams to design and support clinical studies with...on in vitro and in vivo data; partner with CMC and device teams to ensure feasible delivery approaches.… more
- Lifelancer (London, KY)
- … interactions. Cross-Functional Collaboration Partner closely with Clinical Operations, Regulatory Affairs, Program Management, CMC , and external CROs ... Type: Remote Job Contract Type: Full-time Job Seniority Level: Executive Senior Medical Director, Clinical Development (Oncology) Location: US Remote A global,… 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
- Takeda Pharmaceuticals (Lexington, MA)
- …the GRA CMC Product Team CMC strategy. + Combines extensive knowledge of science and regulatory to guide the team to define and drive strategy for CMC ... + Champions, independently develops and leads the execution of regulatory CMC investigational and/or registration strategies for...timely manner. Acts as an advisor and liaison to senior management. + As a member of the modality… 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
- Lilly (Indianapolis, IN)
- …Global Regulatory Affairs - CMC Pre-approval Small Molecules will leverage CMC technical knowledge and regulatory science expertise to drive ... molecule CMC drug development science (s). + Knowledge of global CMC regulatory requirements and guidelines for conducting clinical trials and obtaining… more
- Lilly (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
- Gilead Sciences, Inc. (Foster City, CA)
- …the guidance of more senior staff, oversees the preparation of CMC regulatory submissions for investigational and commercial products with solid scientific ... exciting role of Regulatory Affairs Associate II, CMC sits in Gilead's CMC Regulatory...applicable plans. **For jobs in the United States:** Gilead Sciences Inc. is committed to providing equal employment opportunities… more
- Gilead Sciences, Inc. (Foster City, CA)
- …DESCRIPTION** + Leads a team of CMC RA colleagues to drive global CMC regulatory strategy development for a portfolio of projects from early development ... through the early years of commercialization. + Leads the execution of global CMC regulatory plans, including overseeing the submission preparation process in… more
- Gilead Sciences, Inc. (Foster City, CA)
- …on draft regulatory guidances, and communicates changes in regulatory CMC information to project teams and senior management. + Provides advice and ... with life-threatening illnesses worldwide. **Responsibilities** + Responsible for leading all CMC regulatory activities for assigned project(s), in line with… more
