- 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
- Merck & Co. (Rahway, NJ)
- …Engineering or Science fields.-Required Experience and Skills:Bachelors Degree in life sciences or equivalent with at least 15 years of relevant experience, a ... Team (DCT) leader is-accountable for delivering a fully-integrated stage-appropriate CMC development and commercialization strategy which yields the target… 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)
- …risks across all factors that may impact technical, operational & regulatory success or timelines. -Analyzes and develops innovative solutions to unforeseen ... supply chain to-achieve launch on time and uninterrupted long-term supply.Represents CMC and effectively communicates across the governance bodies, stakeholders, and… more
- Novo Nordisk Inc. (Boulder, CO)
- …Research & Development organization brings together the best minds in life science innovation. The teams located in facilities in Boulder, Lexington, Watertown, ... Novo Nordisk against Custom's fines and penalties. This role ensures regulatory requirements are adhered to and proper documentation, including transit documents… 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)
- …alignment and endorsement for supply chain strategic elements through senior stakeholder management and appropriate executive governance forumsDevelop and maintain ... need to be established Education: Required: Bachelor's degree in Engineering, Science , or Supply Chain ManagementPreferred: Master's degree or higher in related… more
- Regeneron Pharmaceuticals (Troy, NY)
- We are seeking a highly motivated and experienced Senior CMC Regulatory Sciences Specialist (Commercial Submissions) to join our dynamic CMC ... skills are essential for effectively communicating complex scientific information. As a Senior CMC Regulatory Sciences Specialist, a typical day might… more
- Otsuka America Pharmaceutical Inc. (Albany, NY)
- Provide CMC regulatory strategy input and expertise in the area of investigational, new and marketed biologic and small molecule drug products to assigned ... technology, drug manufacturing processes, GMP and related issues. + Knowledge of CMC regulatory requirements for biologics and small molecules during development… 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
- Gilead Sciences, Inc. (Foster City, CA)
- …Join Gilead and help create possible, together. **Job Description** **Responsibilities** + The Regulatory Affairs CMC Senior Manager at Gilead is responsible ... for providing strategic direction, tactical support, and technical expertise for CMC regulatory activities and related regulatory initiatives. + Responsible… 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
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …with 8-10 years pharmaceutical industry experience with 4+ years direct or related CMC regulatory experience or + PhD. with 6-8 years pharmaceutical industry ... medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of...experience and 4+ years direct or related CMC regulatory experience + Successful track record… more
- AbbVie (Boston, MA)
- …various process development functions to ensure technical information is accurately transcribed into regulatory documents. + Lead CMC teams in the development of ... Development Sciences , and Quality Assurance and escalate issues to senior management when appropriate + Contribute on program acceleration and increased… more
- Vera Therapeutics (Brisbane, CA)
- …Development in project teams. * Prepare, review, or edit cGMP batch records, CMC regulatory and quality documents. Qualifications: * PhD/MS in relevant life ... Title: Senior Manager, Early-Stage Biologics Development, CMC ...contact with key stakeholders including Research, Clinical Pharm, Analytical Science , Drug product, Quality Assurance, Regulatory Affairs,… more
- Merck (Rahway, NJ)
- …(DCT) leader is accountable for delivering a fully-integrated stage-appropriate CMC development and commercialization strategy which yields the target commercial ... mitigates risks across all factors that may impact technical, operational & regulatory success or timelines. Analyzes and develops innovative solutions to unforeseen… more
- AbbVie (South San Francisco, CA)
- …Instagram, YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Biologics CMC Development team at AbbVie in the Bay Area has a long ... South San Francisco, the team leverages its comprehensive end-to-end CMC capabilities to work collaboratively through all phases of...modalities, to human clinical studies and eventual licensure. This Senior Scientist I role is within a team of… more
- AbbVie (North Chicago, IL)
- …Instagram, YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description Biologics CMC , a part of Development Sciences within AbbVie's R&D, is ... robust measurement frameworks to deliver business value with data-driven insights to senior leaders. + Preferred background with Biologics CMC (proteins,… more
