Jose Zayas

José Zayas, PhD has worked in the pharmaceutical industry for close to 40 years, covering all areas from Product Development to commercial Manufacturing operations. During his tenure in the industry, he has hosted or participated in over 45 general and pre-approval (PAI) inspections as well as remediation projects. This has included supporting remediation efforts for manufacturing operations under consent decree. He has extensive experience handling compliance to USA, EEA, and other international compliance and regulatory requirements.
José works with startup biotech companies to develop phase-appropriate quality systems that are created with the ability to grow as the company evolves, including systems for managing combination products and radiopharmaceutical manufacturing.
Jose’s vast knowledge of multiple aspects of Quality Control supports clients’ CMC operations within the product development process. He has validated multiple analytical methods for different stages from Phase 1 to commercial drugs, as well as designed stability studies as per ICH guidance, including evaluation of stability data and forecasting expiry/retest dates for drug substances and drug product. His QC experience covers small molecules as well as mRNA analytical tests.
José has authored over a dozen publications across multiple disciplines and is the author of a patent and several patent applications. He holds a Ph.D. in organic chemistry from The Ohio State University and completed his postdoctoral in organic chemistry from Princeton University.