Work hands-on in the laboratory to develop, optimize, qualify, transfer, and validate analytical test methods for both drug substance and drug product, from preclinical nomination through late-phase clinical development;
Conduct in-house stability studies and interpret stability data to justify material use periods;
Build kinetic stability models for formulation screening and packaging selection;
Author high-quality documentation, including methods, protocols, and technical reports;
Coordinate and oversee method validation and testing at contract laboratories and manufacturers;
Collaborate with Chemical Development and Formulation Development scientists on CMC teams to meet program goals;
Act as an exemplary and data-driven scientist with critical thinking and innovative problem solving skills in a fast-paced, can-do environment.
Ph.D with 0-2 years experiences and with in-depth knowledge of analytical principles, including practical experience with HPLC, GC, and MS.Expertise in physical and chemical stability kinetics;
Understanding of techniques for polymer characterization, including GPC and viscometry;Polymer characterization experience is as a plus, not a must have.
Excellent oral and written communication skills.
Contact Brad Parish at brad.parishationgroup.com or 865-804-2723; bradparish.com