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. 

Lourdes Ramos, BS MT has over 25 years overall experience in the regulated healthcare industry covering clinical (GCP), environmental, and pharmaceutical (GMP) areas. She has served as Sr. Clinical Administrator of the Department of Medicine at the University of Miami Miller School of Medicine. There she streamlined operations and maximized overall productivity. During her tenure at the Miller School of Medicine she was instrumental in the creation of the Interdisciplinary Stem Cell Institute (ISCI), a startup clinical research unit dedicated to cardiovascular application of stem cell therapies.  

Lourdes is a certified GCP Auditor and has worked on the product development of antimicrobial formulations, specifically supporting the development of the clinical and non-clinical testing protocols for Phase 1 human studies.   

In the GMP area, she has served as a compliance consultant to consent decree pharmaceutical manufacturing operations focusing on environmental controls of aseptic operations and environmental monitoring programs.  Lourdes supports early-stage companies’ efforts to navigate phase appropriate GMPs through Phase 2/3 studies and consults in large molecules and biologics through the development and creation of validation master plans, validation protocols and reports, environmental assessments, and environmental control programs. As part of supporting CMC teams, she also manages CMOs supplying upstream and downstream processes for the manufacture of clinical supplies for early/late phase studies.