- Lilly (Indianapolis, IN)
- …for people around the world. **Job Summary** The Director /Senior Director , CMC , Drug Product Development will lead formulation development ... (CROs, CDMOs) with capabilities in drug product development and manufacturing + Author CMC sections of regulatory submissions (IND, CTA) related to drug… more
- Lilly (Indianapolis, IN)
- …world. We are looking for a highly qualified statistical leader who will lead the product development statistics team in supporting a wide variety of projects in ... the product development (nonclinical) area of LRL in...novel methods and strategies to enable or advance drug development and manufacturing + Author/review sections of CMC… 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
- Sumitomo Pharma (Indianapolis, IN)
- …FDA and ICH regulations/guidance documents specific to clinical research and general product development in the pharmaceutical industry + Experience reviewing ... with a minimum of 4 years focused in regulatory affairs + Oncology product development experience preferred + Experience contributing to electronic regulatory… more
- Lilly (Indianapolis, IN)
- …Design and Development (SMDD) need for drug substance and drug product development , characterization, and supply of material for toxicology and clinical ... new medicines that will help solve our world's greatest health challenges. In Product Research and Development (PRD), we transform molecules into medicines. Our… 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)
- …sites. + Senior TS/MS management, Product and Technical leaders, development scientists, CMC PMs and molecule stewards. **Basic Requirements** + ... for day to day operation on making and supply medicines and new product commercialization. + Has responsibility for ensuring all products are manufactured according… more
- Lilly (Indianapolis, IN)
- …and documentation across transfers. **Strategic & Portfolio Management** + Partner with CMC PMs and development teams to guide tech transfer execution ... to support communities through philanthropy and volunteerism **Position Summary:** The Senior Director of TSMS - Tech Transfer is a strategic leadership role within… more