- BeiGene (Emeryville, CA)
- **General Description:** + The Senior Manager , Regulatory Affairs CMC , is responsible for developing and implementing global regulatory CMC ... coordination with key internal stakeholders. This position will manage regulatory CMC aspects of compounds (large molecules)...+ 7+ years of experience with a Bachelor of Science degree, in a related scientific discipline, or 5+… more
- Sanofi Group (Bridgewater, NJ)
- **Job title:** Manager , Global Regulatory Affairs CMC + Location: Bridgewater, NJ **About the job:** The Manager , Global Regulatory Affairs CMC ... Products, Biologics, and Vaccines). This individual is responsible for global regulatory CMC strategies, submission dossiers and approvals, including direct… more
- Astellas Pharma (Westborough, MA)
- ** Regulatory Manager , Regulatory Affairs - CMC (Gene Therapy)** Do you want to be part of an inclusive team that works to develop innovative therapies ... remote work are encouraged to apply. **Purpose and Scope:** Responsible for developing regulatory CMC strategy for assigned projects. Identifies and collects … more
- Kelly Services (Vancouver, WA)
- Kelly(R) Science & Clinical is seeking a CMC Project Manager opportunity with a generative AI biotechnology company in Vancouver, WA. If you're passionate ... and regulatory requirements. + Proven track record in supporting CMC programs from development to commercialization. + Experience in biotech, pharmaceutical, or… 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 ... Leads US FDA/EU EMA interactions with support from higher-level manager . + ** Regulatory Knowledge:** Demonstrates expert knowledge...experience and 4+ years direct or related CMC regulatory experience + Successful track record… more
- Frontier Medicines (South San Francisco, CA)
- 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...a strong candidate: + PhD. in Pharmaceutical Chemistry, Materials Science , Analytical Chemistry with 5+ years, MSc. with 8+… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …and/or regulatory affairs + Has knowledge of fundamental understanding in Clinical Sciences , Regulatory CMC , DMPK, Pharmacology and Toxicology + Has ... accountable for ensuring that stakeholders (including executives) are aligned; that regulatory agencies understand Takeda's CMC strategies through active… more
- Gilead Sciences, Inc. (Foster City, CA)
- …help create possible, together. **Job Description** **Key Responsibilities** Senior Manager , Global External Manufacturing Biologics supports uninterrupted supply of ... external contract manufacturing network, while ensuring compliance with cGMP, regulatory requirements, and environmental, health, and safety legislations. This… more
- Gilead Sciences, Inc. (Foster City, CA)
- …documentation practices. . Author technical documents such as protocols, reports, regulatory dossier, etc. and prepare data-focused presentations for internal and ... in project meetings. . Analyze data and draft conclusions before discussing with manager or supervisor. . Support or represent function and work collaboratively on… more
- Actalent (Ledgewood, NJ)
- Fantastic leadership opportunity to oversee a team of MSAT/ CMC professionals! Core Responsibilities: + Responsible for leading R&D team for end-to-end activities ... processes, cleaning, and systems in compliance with FDA, and other regulatory guidelines. Ensure validation protocols and reports are accurate and comprehensive.… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …the design, analysis, and interpretation of chemicals, manufacturing, and controls ( CMC ) study data throughout Pharmaceutical Sciences , promoting innovative ... of your future at Takeda. Join us as a Manager of Statistics in our Cambridge, MA office. Here,...analysis methodology. **OBJECTIVE:** + Provide statistical support for Takeda CMC campaigns for design and analysis in analytical development… more
- Takeda Pharmaceuticals (Boston, MA)
- …development functions. + Prepare and coordinate completion of technology transfer documentation, CMC sections of regulatory documents, or validation plans and ... technical objectives (project and scientific related) with input from manager as needed. + Identify and recommend vendors as...Ability to design and direct analytical strategy to meet CMC project objectives. + Experience in preparing regulatory… more
- West Pharmaceutical Services (Exton, PA)
- …ISO 14971, ISO 15223, IEC 62304, ISO 11608), 21 CFR Part 820 and CMC regulatory requirements. + Experience in medical device life-cycle Management, including ... guidance documents and current state-of-art standards/regulations. + Collaborate with regulatory lead(s), cross-functional project manager (s) and SMEs (Subject… more
- Takeda Pharmaceuticals (Lexington, MA)
- …in Pharmaceutical Sciences , Supply Chain Operations, Quality Assurance and CMC - regulatory Affairs, while serving as an important point of technical ... Minitab, etc.). + Experience in global product launches and the associated CMC regulatory requirements. + Provide leadership for important deliverables,… more
- Novo Nordisk (Boulder, CO)
- …new laboratory completed in 2021 to support analytical and process development, the CMC team works alongside Quality, Regulatory , Technical Operations and RNAi ... 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
- Lilly (Indianapolis, IN)
- …teams towards an established timeline that meets customer requirements and supports CMC and Regulatory timelines + Responsible for Tech Transfer Plans/Reports ... Assembly and Packaging (IDAP) within the Technical Services and Manufacturing Sciences (TS/MS) team, provides project management oversight to achieve the reliable… more
- Bristol Myers Squibb (Devens, MA)
- …interpretation of regulations as they apply to Cell Therapy . + Experience with regulatory inspections and CMC + Experience with Quality Management System. + ... their personal lives. Read more: careers.bms.com/working-with-us . **Title: Sr. Manager / Associate Director, Global Sterility Assurance CTTO** **Location: Seattle,… more
- Schrodinger (Cambridge, MA)
- …stakeholders including DMPK, translational medicine, clinical development, clinical operations, regulatory , CMC , and project management to ensure completion ... We are looking to hire a **Senior Manager /Associate Director of Clinical Pharmacology** to join us...protocols, analysis plans, and study reports + Contribute to regulatory submissions and health authority agency interactions relevant to… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- Regeneron is seeking a highly motivated ** Manager , Scientific Writing** to supervise regulatory submission drafting activities for preclinical pharmacokinetics ... Toxicology, and Pharmacology) as well as select documents supporting CMC and Clinical Pharmacometrics content. **A Typical Day Looks...a minimum of an MS degree in a Life Science with 7+ years in regulatory submission… more
- Taiho Oncology (Princeton, NJ)
- Sr. Manager , Outsourcing & Vendor Management Princeton, NJ, USA Req #339 Friday, June 28, 2024 Looking for a chance to make a meaningful difference in the oncology ... and each other. Together, we are working on cutting-edge science and growing our portfolio and pipeline across a...and expanding mid-size company in the role of Sr. Manager , Outsourcing and Vendor Management. Your expertise will play… more