Pedro Hernandez Email & Phone Number

Dr. Pedro E. Hernández obtained his Ph.D. degree in organic chemistry/natural products synthesis at the University of Pennsylvania with Prof. K.C. Nicolaou, followed by a post-doctoral research appointment at the University of Oxford in the UK with Prof. G.W.J. Fleet, focused on carbohydrate chemistry. He has worked in drug discovery or scale up with Smith Kline Beecham, Johnson Matthey Biomedical Research, Zynaxis, Albany Molecular Research and taught at the University of Puerto Rico.To date, Dr. Hernández has authored numerous papers in peer reviewed journals and 13 US and international patents on a wide range of therapeutic areas including cardiovascular, imaging agents for MRI, four process patents on Zyrtec® (allergy medication) and one on TELCYTA®, an anti-cancer agent currently in phase III clinical trials, peptidomimetics and antiviral macrocycles (HIV).Over the years his career has evolved much like a drug product, from discovery chemistry to scale up process chemistry for API supply and later finished drug product and PAT. In February 2004 Dr. Hernández joined Wyeth in Guayama Puerto Rico as a Sr. Technology Transfer Scientist II where he was involved in the registration, validation and commercial launch of Lybrel® and Pristiq ®. In 2005 he moved on to lead the PAT group within the Technology Department. In 2008 he became Associate Director QbD/PAT at Wyeth (now Pfizer) in Pearl River, NY. He was part of the project team responsible for QbD/PAT implementation that obtained real time release approval from the FDA.Areas of expertise have expanded from API to finished drug product manufacturing and packaging using a variety of technology platforms in the USA and internationally, finished drug product process QbD, PAT, CMC and regulatory agencies (FDA, EMEA, IMB) and ICH.He was Senior Director Quality-China in overseeing CMC, Clinical and Bioanalytical areas for Frontage in China and Director Quality by Design at Merck Serono in Switzerland.Specialties: PAT Instrument Selection, Instrument Design/Construction, API synthesis/characterization, QbD, Management, Basic Automation, Spectroscopy, Basic Chemometrics, Risk Management, Risk Mitigation using PAT Tools, Design of Experiments, Method Development, Method Validation, Tech Transfer, etc.

Listed skills include V&V, Quality By Design, Spectroscopy, Technology Transfer, and 46 others.