- Lilly (Philadelphia, PA)
- …and advance care for patients with unmet needs. **Position Overview:** The Associate Director , CMC Development will be responsible for the execution of multiple ... Process Development, Analytical Sciences, Manufacturing, Quality, Supply Chain, R&D, Finance, and Regulatory to ensure delivery of CMC milestones for priority… more
- AbbVie (North Chicago, IL)
- …external third parties. The primary function is to ensure consistent preparation of CMC regulatory submission documents of high scientific and technical quality ... strong negotiating, influencing, and leadership skills. + Manages completion of CMC regulatory submission documentation for multiple projects of moderate… more
- Boehringer Ingelheim (Ridgefield, CT)
- …Ingelheim is currently seeking an Associate Director or Senior Associate Director to join our External Alternative CMC Development (EACD) department located ... for leading all DP-related activities within the project(s), in support of CMC development within EACD. The Associate Director /Senior Associate Director… more
- Kelly Services (South San Francisco, CA)
- Kelly(R) Science & Clinical is seeking a Director of CMC Quality for a direct hire opportunity with a leading biopharmaceutical company in South San Francisco, ... in South San Francisco, CA 3 days/week. **Position Title:** Director of CMC Quality **Position Type:** Direct...regulatory and quality standards. Reporting to the Executive Director of Quality Assurance, you'll collaborate with various GxP… more
- Organon & Co. (Jersey City, NJ)
- …Scientist (Associate Director ) is responsible for developing and implementing Regulatory Chemistry, Manufacturing & Controls ( CMC ) strategies for assigned ... the product lifecycle + Identify, communicate and escalate potential regulatory issues to Organon Regulatory CMC...and escalate potential regulatory issues to Organon Regulatory CMC management, as needed **Required Education,… more
- AbbVie (North Chicago, IL)
- …Chemistry, Manufacturing, and Controls ( CMC ) strategic project plans to support CMC regulatory deliverables such as INDs/IMPDs and Marketing Applications. ... LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Program Manager, CMC Dossier Management assists with the development and oversight of… more
- Takeda Pharmaceuticals (Boston, MA)
- …to the best of my knowledge. **Job Description** **About the role:** As a CMC Lead, Small Molecules (Associate Director ), you will be responsible for leading ... to the world. **How you will contribute:** + Provide strong direction to CMC Leads to drive effective life cycle management for Takeda's commercial small molecule… more
- Gilead Sciences, Inc. (Washington, DC)
- …devices. . **Global Regulatory Excellence** Lead the development of global CMC regulatory initiatives focused on combination products and devices. Ensure ... directly relevant professional experience in small molecule and biologics development, global CMC regulatory affairs and CMC technical areas of at least 16… more
- Sumitomo Pharma (Tallahassee, FL)
- …currently seeking a dynamic, highly motivated, and experienced individual for the position of ** Director Regulatory Affairs** . The Director is part of the ... (GRA) team based in the US. He/she will primarily function as the Regional Regulatory Leader (RRL) and/or Global Regulatory Leader (GRL) for assigned projects.… more
- Lilly (Indianapolis, IN)
- …drug development experience for 10 years + Direct experience in clinical and CMC regulatory sciences + Experience in applicable therapeutic area + Knowledge ... around the world. **Purpose:** The purpose of the Senior Director , Global Regulatory Affairs, Global Regulatory...affiliate requirements. The GRL builds and leads the Global Regulatory Team (inclusive of GRA central functions, GRA- CMC… more