The successful candidate will independently perform analytical testing, method development and method validation.
Assist with establishing specifications for APIs, excipients and drug products. Develop justification of these specifications to be included in regulatory submissions
Critically review and evaluates stability data. Establishe trends between multiple studies. Recommend and assist with establishing shelf life of new drug products
Coordinate the gathering of necessary documents and assists with writing portions of the CMC submission document
Proven problem solving, communication, and technical skills