- Lilly (Indianapolis, IN)
- …a proactive leadership role in the critical review of molecule specific CMC development strategies and submission content for registration, post-approval ... Demonstrated deep technical knowledge and experience of small molecule drug product development , commercialization and manufacturing processes. + Prior… more
- Lilly (Indianapolis, IN)
- …strategy based upon global regulatory changes. + Provide regulatory guidance to allow CMC development teams to make well-informed decisions on development ... + Takes a proactive leadership role in the critical review of molecule specific CMC development strategies and submission content. + Makes decisions on CMC… more
- Lilly (Indianapolis, IN)
- … Project Management is the program and project management arm of our critical Product Research and Development group. CMC Project Managers are responsible ... teams and therapeutic areas to translate clinical, asset and portfolio strategy into clear CMC development and delivery goals for cross-functional CMC teams.… more
- Bristol Myers Squibb (Indianapolis, IN)
- …leader in radiopharmaceuticals . We are seeking an experienced and motivated **Senior Director , Regulatory Affairs - CMC (Manufacturing)** . This position will ... Application (NDA), and Marketing Authorization Application (MAA) submissions + Lead the development and execution of global CMC regulatory strategies for… more
- Lilly (Indianapolis, IN)
- … cycle (proof of concept) to product commercialization + Experience in development / CMC including quality and regulatory interactions is expected + ... purification, isolation, and formulation. The position presents an opportunity to lead CMC activities to support clinical trials, product commercialization, and… more
- Otsuka America Pharmaceutical Inc. (Indianapolis, IN)
- …including sample collection, storage conditions, and analytical testing, to support product development and regulatory submissions. + Author and review ... **Associate Director , Small Molecule Analytical Development ** +...development and optimization for drug substance and drug product at CDMOs + Design and lead method validation… more
- Lilly (Indianapolis, IN)
- … product (including delivery device and relevant medical devices) development , registration, and lifecycle maintenance globally. Ensure regulatory strategy is ... + Lead Global Regulatory Team consisting of regional regulatory scientists, GRA- CMC , GRA-Devices, GRA-RD&E, and GRA-Global Labeling and Product Communications.… more
- Lilly (Indianapolis, IN)
- … product (including delivery device and relevant medical devices) development , registration, and lifecycle maintenance globally. Ensure regulatory strategy is ... + Lead Global Regulatory Team consisting of regional regulatory scientists, GRA- CMC , GRA-Devices, GRA-RD&E, and GRA-Global Labeling and Product Communications.… more
- Lilly (Indianapolis, IN)
- …Develop the future technical leadership for the site and for potential assignments across Product Research & Development ( CMC ) and manufacturing. + Works ... Lilly Medicine Foundry, a new center for advanced manufacturing and drug development . The first-ever facility of its kind, combining research and manufacturing in… more
- Lilly (Indianapolis, IN)
- …changes in timeline, objectives, or direction. + Collaborate across internal CMC networks (Drug Product Delivery, Project Management, Quality, Manufacturing, ... other experience may meet expectations. Prior experience in active ingredient development and associated formulated product is acceptable. Relevant industrial… more