top of page
Mike M Headshot_edited.jpg

Michael McCalister

Director of External Manufacturing/ Senior Project Manager

Biopharmaceutical professional with over 20  years of experience in all phases of Manufacturing, Facility Design, and Tech Transfer. Capable of advancing products through full lifecycle utilizing a mindset focused on implementation of phase appropriate Quality Systems. Collaborative leader with ability to effectively communicate, analyze complex issues, and focus on resolution. Experienced with direct interaction with FDA and other regulatory agencies during inspection of Phase I, II, III, and commercial manufacturing facilities, technical support, validation, CDMO representative, and clinical to commercialization. Broad skillset including IND drafting, CDMO management, manufacturing/ production readiness, validation readiness, contract negotiation, and budget/ production forecasting.

bottom of page