- 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
- 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
- Gilead Sciences, Inc. (Foster City, CA)
- …Gilead Sciences is seeking a talented and highly motivated Senior Scientist to join our Pre-Pivotal Biologics Analytical Operations group. Our collaborative ... collaborations with other CMC functions. + Familiar with lab automation, data science and knowledge management is a plus. + Create Inclusion - knowing the… more
- AbbVie (North Chicago, IL)
- …the broader decision-making process on external L&A opportunities. + Apprise Development Sciences CMC Leadership of development strategies, risk assessments, and ... CMC product development strategy and executable plans. Key Stakeholders: VP Development Sciences , Development Sciences CMC Functional Heads, S&E and BD… more
- Takeda Pharmaceuticals (Boston, MA)
- …of Pharm Sci CMC Governance Office:** Accountable for facilitating the Pharm Sci CMC Governance advisory board, comprised of senior -level CMC experts to ... top-tier development cycle times to accelerate drug to patients. **Accountabilities:** + Senior level R&D CMC portfolio strategy leader accountable for… more
- Gilead Sciences, Inc. (Foster City, CA)
- …aspirations. Join Gilead and help create possible, together. **Job Description** Gilead Sciences , Inc. is a biopharmaceutical company that has pursued and achieved ... more than 35 countries worldwide, with headquarters in Foster City, California. ** Senior Director, Global Clinical Supply Chain** Senior Director, Global… more
- Gilead Sciences, Inc. (La Verne, CA)
- …Packaging, Quality Assurance (QA), Quality Control (QC), Validation, Supply Chain, Regulatory / CMC , EHS, Finance, IT, and Engineering. **Project Team ... will improve the lives of patients with life-threatening illnesses worldwide. Gilead Sciences La Verne Engineering is seeking a highly motivated and knowledgeable **… more
- Gilead Sciences, Inc. (Foster City, CA)
- …help create possible, together. **Job Description** **Key Responsibilities** Senior Manager, Global External Manufacturing Biologics supports uninterrupted supply ... external contract manufacturing network, while ensuring compliance with cGMP, regulatory requirements, and environmental, health, and safety legislations. This… more
- Lilly (Stamford, CT)
- … or leadership assignments across multiple countries + Direct experience in clinical and CMC regulatory sciences + Knowledge of Global regulatory ... people around the world. **Purpose:** The purpose of the Senior Director, Global Regulatory Affairs, Global ... policies, regulatory precedents, trends, and emerging regulatory science . Integrate information from the external… more
- Gilead Sciences, Inc. (Foster City, CA)
- …+ Lead collaborations with Gilead PDM functions such as Quality Assurance, CMC Regulatory Affairs, Manufacturing and Technical Operations, Product and Portfolio ... and long-range plans with respect to analytical control strategies and regulatory strategies for drug substance and drug product quality attributes across… more