Elicio’s analytical chemists will monitor and evaluate activities across multiple programs in different stages of development in a virtual manufacturing environment. Responsibilities include using analytical method development, reviewing method transfer and method validation, developing specification criteria, tracking source documents as well as vendor CoA and testing of critical intermediates, reviewing stability protocols and reports, and identifying GAPS in vendor internal systems and working to improve internal systems for GMP compliance.
Minimum requirements include:
- PhD or equivalent in biology
- Experience with ICH guidelines and USP
- Experience working and managing CMOs, CROs and external vendors
- Experience with method validation