Irvine Pharmaceutical Services | Executive Leadership

EXECUTIVE LEADERSHIP

Assad J. Kazeminy, Ph.D., President and Founder of Irvine

Assad J. Kazeminy, Ph.D., Chairman & Founder, has over 30 years of research experience in Analytical Chemistry and Biochemistry and has been involved in teaching and management aspects for analytical and quality control laboratories for Pharmaceutical and Nutraceutical companies. Dr. Kazeminy has a Ph.D. in Pharmaceutical Science and Biochemistry and has completed a post doctorate at the USC Medical School, Department of Pharmacology. In addition, Dr. Kazeminy has taught at the University of Southern California and has conducted research at the University of California Irvine. He has extensive knowledge in and is proficient in FDA regulations and various compendia methodologies. Dr. Kazeminy is an active professional in national and local organizations including the United States Pharmacopeia serving as an Expert Committee member. He has made many contributions towards advancing the pharmaceutical sciences, whereby his efforts have been very influential in shaping and reforming current industry standards (most recently, USP Chapter <231>, Heavy Metals).

Aryo A. Nikopour, Vice President of Scientific and Technical Services, joined Irvine Pharmaceutical Services in January 2004. Mr. Nikopour has over 18 years of experience in the pharmaceutical industry with expertise in the areas of chromatographic method development & validation, management of scientific staff and implementation on new technologies and capabilities. In addition, he has gained experience in the areas of quality control, stability testing and regulatory requirements. Mr. Nikopour received a B.S. Degree in Chemistry from the University of Southern Minnesota.

Eduardo A. Uribe, Senior Director of Quality Operations, has over 20 years of experience in the biotech and pharmaceutical industry. Prior to joining Irvine Pharmaceutical Services, Inc. his experience included virology and forensic toxicology contract labs, bacterial and viral commercial vaccines, sterile injectable pharmaceuticals and fill-and-finish operations. He has a comprehensive understanding of cGMP regulations, ISO and EU guidelines and has held positions at SmithKline Beecham, Merck & Co. and SkyePharma, Inc. Eduardo earned a B.S. in Biology with an emphasis in Chemistry.

Quanyin Gao, Ph.D., Director of Analytical Development, has over 15 years pharmaceutical research and development experience spanning from bulk APIs, parenteral, inhalation, and solid dosage form pharmaceuticals. His research area includes physical chemical properties and characterization of small molecules and biomolecules, chromatographic method development and validation, extractables and leachables studies, bioanalytical characterization and quantitation. His work involves product development with raw material testing and release, method development, method validation, method transfer, and stability programs.

Dr. Gao has extensive regulatory filing experience with CMC documentation such as DMFs, IND, NDAs, and ANDAs. Prior to joining Irvine in early 2009, Dr. Gao worked at Watson Pharmaceuticals, Inc., B. Braun Medical, Inc., and Teva Pharmaceuticals, Inc. Dr. Gao received his Ph.D. in Chemistry from the University of California, Irvine and conducted his Postdoctoral Research at the University of Pittsburgh and Pacifica Northwest National Laboratories. He has more than 20 publications in surface science, mass spectrometry, and analytical chemistry. Dr. Gao had previously partnered with his colleagues to coauthor a chapter on the topic of method development and validation for solid dosage form generic drugs. He is currently a USP Expert Committee member for the new monograph of Pulmonary and Steroids.

Hamid Forouhar, Director of Analytical Chemistry, has been with Irvine Pharmaceutical Services since 1999. Previously, Mr. Forouhar was with Watson Pharmaceuticals where he was responsible for QC raw material testing and release. He has over 17 years of experience in pharmaceutical and petrochemical industries. In his current position, Mr. Forouhar is responsible for the QC department including the pharmaceuticals and nutraceuticals groups and stability studies following USP, NF, EP, BP, JP, ACS, AOAC guidelines and in-house test methods. Mr. Forouhar received his B.S. Degree from University of Wisconsin, Madison.

Joseph Bordas-Nagy, Ph.D., Associate Director or Structural Chemistry, brings experience working at leading pharmaceutical and drug delivery device companies including leadership roles at Amgen, ALZA Corporation, Sandoz, and SmithKline Beecham Pharmaceuticals. He has led groups and had management responsibilities in establishing impurity profiles in raw materials, drug substances, drug products and drug delivery devices for regulatory submissions and has led analytical chemistry approaches to characterize drug delivery devices for regulatory purposes. He also has extensive experience in characterizing polymers applied in drug delivery devices and establishing extractables/leachables profiles, characterizing raw materials used in manufacturing of drug products, and establishing correlations between physical chemical characteristics of materials and functional performance while working in GMP/GLP environment.

Dr. Bordas-Nagy received a Ph.D. in Chemistry from the University of Ottawa, a M.S. degree in Chemistry from the Faculty of Natural Sciences of the Eotvos Lorand University of Budapest, and a B.S. degree in Chemical Engineering from the Technical University of Budapest.

Saeed Hashemi, M.Sc., Senior Manager of Analytical Development, has more than 10 years of experience in the pharmaceutical industry with expertise in the areas of Near Infrared Spectroscopy, Raman, NIR Imaging, chemometrics, chromatographic method development, validation, and implementation of new technologies and capabilities. Prior to joining Irvine Pharmaceutical Services Saeed worked at Wyeth Pharmaceuticals as a lead scientist for the implementation of NIR spectroscopy, Raman and Raman Imaging. In addition Mr. Hashemi was responsible for process improvements, process scale-up and technology transfer, and implementation of new tools and technologies in a manufacturing setting.

Saeed was also a part of Wyeth's commercialization strategy team for technology transfer, which played an integral role in developing and streamlining Wyeth's technology transfer process. His team successfully explored, developed and implemented novel technologies such as NIR Imaging, Conventional NIR, Raman Imaging, Raman, Thz, Effusivity, and PAT-like technologies to increase manufacturing reliability and efficiency. In this role he was responsible and accountable for providing strategic and operations leadership perspective to ongoing integrated and cross-functional Quality by Design and PAT decisions through overseeing and coordinating all aspects of the small molecule Operating Unit.

Mr. Hashemi received a B.S. in Chemistry from Purchase College, State University of New York and an M.S. in Chemistry from Polytechnic University New York.

Rudy Flach, M.S., Senior Manager of Formulation Development, has over fifteen years of experience in the pharmaceutical industry with expertise in pre-formulation development and formulation development, product technology transfer, parental dosage forms (i.e. liquid, lyophilization, suspensions, emulsions, and liposomes), statistical experimental design (DoE), physical and chemical evaluation of polymorphs, nanotechnology, drug delivery, IV bag characterization, and manufacturing support.

Prior to joining Irvine in 2007, Rudy spent 10 years contributing to numerous NDA's / ANDA's sterile product submissions at Teva Pharmaceuticals, Inc. All of which led to 13 successful product launches in the US and worldwide markets. Before that he spent several years at Baxter Cardiovascular Group developing alternative sterilization processes for implantable heart valves. Rudy has extensive experience in diverse and complex parental formulations, analytical techniques, and NDA/ANDA submissions. Rudy received his B.S. in Chemistry from the University of California, Irvine and his M.S. in Organic Chemistry from California State University, Fullerton.

William Siegfried, Manager of Microbiology, has over six years of experience in the pharmaceutical, medical device, and nutraceutical industries. Prior to joining Irvine Pharmaceutical Services, Will was Manager of the Microbiology laboratory at a contract testing facility. He has led a team of scientists supporting both analytical and microbiological testing of raw materials, in-process, finished product and environmental samples. Will has experience with Microbial Identification using phenotypic and genotypic methods as well as the use of PCR and gel electrophoresis for pathogen screening. Will has experience with validation of systems, equipment and analytical methods. Will holds a Masters Degree in Biochemistry and Molecular Biology from University of California, Riverside.

Joel A. Spinks, Manager of Validation, has over 16 years experience in the pharmaceutical, biotech, and medical device industries with expertise in software development, computerized systems validation, and facility commissioning. Having detailed technical knowledge of laboratory and manufacturing systems automation, Joel has served lead roles in the successful startup and commissioning of facilities for aseptic pharmaceutical production and solid dosage manufacturing plants in Southern California. His employment history includes roles at Genentech, Teva Pharmaceuticals, Amylin, Pfizer La Jolla, and Carlsbad Technologies. Joel possesses a B.S. in Microbiology and holds professional certifications in Oracle Database Administration and Computer Networks.