- Lilly (Indianapolis, IN)
- …saving therapeutics. **Role Overview:** We are seeking a veteran and visionary Sr. Director of Early Phase Chemistry to join our leadership team. This individual ... + Partner with cross-functional teams to ensure seamless integration of CMC development activities with other areas including discovery, toxicology, clinical… more
- Lilly (Indianapolis, IN)
- …Author and deliver high-quality technical protocols and reports. Collaborate with CMC and regulatory groups to support submissions and address agency questions ... and requirements. + Work with external suppliers to develop specification of packaging components and systems + Work with both internal and external manufacturing teams to ensure appropriate qualifications of packaging components and systems, as well as… more
- Lilly (Indianapolis, IN)
- …global regulatory climate and emerging requirements. Ability to address key CMC regulatory questions that enable clinical studies and support marketing authorization ... applications. **Minimum Qualifications:** + Ph.D. in chemical engineering or a closely related field with 8+ years of experience; or Master's degree with 15+ years of experience. + Experience with developing chemical processes the from mid-development cycle… more
- Lilly (Indianapolis, IN)
- …for use in clinical trial manufacturing. + Lead the preparation of the CMC portion of the IND/CTA/BLA/NDA. + Build process capabilities for lab scale, early ... phase clinical scale, and scale-up technologies for novel parenteral drug product and other complex formulations. Instill mindset of fundamental engineering knowledge into process development activities. + Lead tech transfer of process and formulation to… more
- Lilly (Indianapolis, IN)
- …analytical chemists, bioconjugation scientists, biologics development team, engineers, CMC project management, Lilly manufacturing partners, and regulatory ... scientists to develop and commercialize ADCs. + Manage multiple projects and/or material deliveries simultaneously. + Oversee phase appropriate development activities such as route selection, process definition, and process characterization. + Partner with… more
- Humana (Indianapolis, IN)
- …mitigate risks. The Senior Clinical Compliance Professional will support the Director of Compliance, by ensuring compliance with governmental requirements for ... pharmacy knowledge a plus + Certified Coder (CPC, CRC, and/or CMC ) + Experience with metrics and reporting **Additional Information** **Work-At-Home Requirements:**… more