Our team is a dynamic, dedicated group of individuals united by a passion for service and a commitment to quality and innovation. Our unique combination of industry acumen, technical expertise and entrepreneurial skills make AAIPharma a leading provider of comprehensive outsourcing services to the pharmaceutical and biotechnology industries.
Jeff Yuen, MPH, MBA
Executive Vice President, Global Quality
Jeff Yuen is a well-respected domestic and international speaker with nearly 30 years of compliance and regulatory experience; Jeff was a peace officer/investigator with the State of California, Food and Drug Branch and a Consumer Safety Officer for the US FDA respectively. During his tenure with the US FDA, he was rapidly promoted to the rank of Commander in the US Public Health Service while serving as a member of the following teams:
FDA’s Pacific Regional Biotech Team (pre-cursor to ORA Team Biologics)
Los Angeles District Drug Team; and
Foreign Inspection Cadre.
Yuen served as District Drug Team Leader and Drug Pre-Approval Manager during his time with US FDA. Yuen specialized in both high priority drugs (PAI) and biologics (ELA and BLA) inspections. He is well widely recognized as a CGMP and compliance expert by industry and CDER Office of Compliance in the area of sterile drug manufacturing particularly with regard to inspection of biotech products, aseptic filling, quality systems, and process validation. Yuen is the recipient of numerous US Public Health Commendation and Achievement medals including a “Hammer Award” presented by Vice President Al Gore’s Office for his participation and leadership in the area of innovative biotechnology/FDA industry outreach programs.
Since leaving the FDA in 1998, he was founder of Jeff Yuen & Associates, Inc., a well-recognized and well-respected independent regulatory compliance consulting firm specializing in FDA matters such as the following: developing domestic and international regulatory and compliance strategies in the area of PAI/BLA and A/NDA PAI preparation, simulated FDA mock inspections, conducting CGMP gap assessments, conducting due diligence audits, troubleshooting technical issues and interpreting compliance problems, evaluating existing and future compliance risks and liabilities, and providing CGMP training seminars.
Vice President and General Counsel, Corporate Secretary
Scott Warner has more than 35 years of experience in contract services businesses. Prior to joining AAIPharma Services, Scott helped clients negotiate, coordinate and close complex commercial transactions as a business transactional attorney.
Scott was appointed by the Attorney General of Ohio to represent the investment fund of the Ohio Public Employees Retirement System, which had more than $60 billion in assets under investment. He was also appointed by former President Bill Clinton in 1995 to serve as one of three U.S. representatives on a bilateral diplomatic committee to resolve issues related to the transfer of control of the Panama Canal.
Scott holds a J.D. and an M.B.A. from Ohio State University. He is a member of the Ohio Bar Association.
Executive Vice President, Analytical Labs
Dean joined AAIPharma Services as a senior scientist in 1992 and has held numerous scientific positions with the company in the method development and analytical groups. His areas of interest are HPLC, GC, chiral separation, preparative chromatography and optimization of experimental conditions in chromatography. With more than 50 publications in well-known scientific journals, Dean is a nationally recognized expert in the field of chromatography.
Dean earned his Ph.D. in analytical chemistry from Georgetown University and did his post-doctoral research at the University of Tennessee.
Vice President, Sales & Client Services
Rob Goshert became vice president of Manufacturing Business Operations at AAIPharma Services after previously heading the company’s business development and corporate accounts divisions.
Rob brings 30 years of proven leadership in business development, sales and marketing, business operations, facility management and corporate accounts to his role with AAIPharma, and his experience spans proprietary pharmaceuticals, critical care generics, parenteral contract manufacturing, bio-assay diagnostics and pharmaceutical development services. His career includes positions with CIBA-Geigy, Lyphomed, Fujisawa USA and Gensia Sicor.
Rob graduated with a Bachelor of Science degree from Butler University in Indianapolis.
Vice President, Client Services
As Vice President Client Services, Wendy leads the Project Management, Business Analysis, and Client Relationship teams. She is an experienced professional in the pharmaceutical contract services business with more than 18 years supporting customers in product development and commercial manufacturing. Wendy joined AAIPharma Services in June 2011 as Sr. Director, Project Management.
Prior to joining AAIPharma Services, Wendy spent 17 years at Baxter Pharmaceutical Solutions in Bloomington, IN. She held roles in Microbiology, Regulatory Affairs, and Sterility Assurance prior to moving into Project Management.
Wendy has a Bachelor’s of Science Degree in Biology from Indiana University. She has taken graduate level courses from the Kelley School of Business at Indiana University. She is PMP certified and a member of the Project Management Institute.
Senior Director, Laboratory Quality Services
With 25 years of experience in the pharmaceutical and medical device industries, Brian joined AAIPharma in 1993 and has served throughout our Quality and Regulatory departments. He has worked as a Quality Auditor for analytical operations and in multiple business roles including laboratory quality and generic product development. He held a lead role for Quality in the former product division for AAIPharma, as well as managed the Quality responsibilities for analytical and manufacturing operations.
Brian earned his B.S. in Chemistry from Carson-Newman College and his M.B.A. from the University of North Carolina – Wilmington.
Senior Director, Manufacturing Quality Services
Eduardo A. Uribe has over 20 years of experience in the biotech and pharmaceutical industry working in a variety of executive management roles at SmithKline Beecham, Merck & Co., SykePharma and EMD Millipore. His experience includes virology, forensic toxicology, bacterial, viral and recombinant vaccines manufacturing and he has expertise in a variety of fill/finish operations. With a comprehensive understanding of cGMP, ISO and EU guidelines, and experience in working with clients on a global basis, Eduardo leads the Manufacturing Quality Services team.
Eduardo earned a B.S. in Biology from Kutztown University and was awarded the Henry Remsberg Memorial Scholarship.