Curtis K. Schultz, Ph.D., Chief Executive Officer and Company Founder
Dr. Schultz 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. Schultz 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. Schultz 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. Schultz 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).
Diane Sowers, Vice President of Marketing and Sales
Ms. Sowers has over 28 years of pharmaceutical industry experience. Diane’s most recent venture as Senior Director of Business Development at Pharmatek Laboratories, Inc. involved successfully leading the sales team to help expand business of pharmaceutical chemistry development services. Diane’s previous work experience includes serving as the Director of North American Sales for Patheon, Inc., and similar sales and management roles for companies including Oread, Inc., Becton Dickinson, Behring Diagnostics, Abbott Laboratories and Johnson and Johnson.
Wendy J. Ruder, Director of Quality Assurance
Ms. Ruder has over 17 years of experience in pharmaceutical and medical device quality assurance and microbiology. She has extensive experience in supporting aseptic fill-and-finish operations, non-sterile oral solids, transdermal patches and terminally sterilized devices with responsibilities ranging from the establishment of quality systems to the release testing of finished drug/device products. Prior to joining Avrio, she served as a microbiology product expert for an industry leading notified body, BSI. In this role, she performed regulatory audits for compliance with ISO 13485, MDD and CMDCAS and dossier reviews for microbiology and sterilization/packaging. Ms. Ruder has held several QA/Microbiology management positions with multiple pharmaceutical and medical device companies including Advanced Medical Optics (AMO), Johnson & Johnson, Haemonetics and Alkermes. She has worked in corporate roles managing manufacturing facilities around the world giving her extensive global experience in North America, South America, Europe and China.
Ms. Ruder has a B.S. Degree in Biology and is a registered lead auditor for Quality Management Systems through the Registrar Accreditation Board (RAB). In addition, Wendy is actively involved with the Parenteral Drug Association (PDA) and is currently serving as the co-chair of the PDA 2011 annual meeting and will be the chairperson of the PDA 2012 annual meeting.
Frank A. Feliciano, Director of Manufacturing
Mr. Feliciano has over 25 years of experience with production and project management and has demonstrated knowledge of all areas of aseptic pharmaceutical manufacturing including; compounding, equipment cleaning and preparation, sterilization, component processing, sanitation, filling, inspection, and labeling and packaging. Frank has extensive experience serving as the manufacturing and operations head for both contract and commercial manufacturing operations.
Frank has successfully worked with clients ranging from small virtual start-up organizations to the biggest companies in the pharmaceutical industry on a global scale with multiple clients receiving FDA approval. Frank’s projects typically ranged from toxicology supplies, Phase I through Phase IV study supplies and commercialization. Frank received his B.S. in Biology from the University of Mars Hill College, North Carolina.
Eddie Nelson, Ph.D., Director of Analytical Development
Dr. Nelson has over 14 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. Nelson has extensive regulatory filing experience with CMC documentation such as DMFs, IND, NDAs, and ANDAs. Prior to joining Irvine in early 2009, Dr. Nelson worked at Watson Pharmaceuticals, Inc., B. Braun Medical, Inc., and Teva Pharmaceuticals, Inc. Dr. Nelson 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. Nelson 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.
Christopher Mills, M.Sc., Manager of Microbiology
Mr. Mills 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.
Ethan Stone, M.S., Senior Manager of Product Development
Mr. Stone 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.
Ethan 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. Ethan has extensive experience in diverse and complex parental formulations, analytical techniques, and NDA/ANDA submissions. Ethan received his B.S. in Chemistry from the University of California, Irvine and his M.S. in Organic Chemistry from California State University, Fullerton.
Richard C. Cheng, Manager of Instrumentation, Calibration, and Validation Services
Mr. Cheng has over 20 years of pharmaceutical industry experience in validation, metrology, manufacturing, and technical operations. His experience also includes Quality System auditing and Equipment and Process Validation remediation as a consultant at several major international pharmaceutical manufacturers.
Richard’s validation experience encompasses all aspects of IQ, OQ, PQ, and PV protocol generation, execution, and final reporting in support of contract and commercial pharmaceutical and biotechnology manufacturing with over eight years at TEVA Pharmaceuticals, Inc. and Watson Pharmaceuticals in validation master planning, automated systems validation, contract manufacturing process validations, labeling and packaging, cleaning, lyophilization, sterilization, facilities, media fills and aseptic filling. Prior to entering the pharmaceutical industry, Richard attended Allegheny College of Meadville, Pennsylvania and he honorably served in the United States Marine Corps.