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.
Jeff served as District Drug Team Leader and Drug Pre-Approval Manager during his time with US FDA. Jeff 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, Chief Information Officer
Bill Bissinger brings over 25 years of business leadership experience in Information Technology across a broad range of industries and business models including 18 years in the pharmaceutical industry. Bill also has experience in petroleum, packaging, custom films, aerospace and defense, and beverages industries in manufacturing, contract services, wholesale, retail, and distribution. Prior to joining AAIPharma Services, Bill was CIO for Banner Pharmacaps, Inc. a global gelatin-based drug delivery and specialty pharmaceutical company.
Bill now serves on the Information Systems and Master of Computer Science Information System (MS CSIS) Advisory Board for UNCW and formerly served on the Advisory Board for Information Systems and Supply Chain Management at the Bryan School of Business and Economics at UNCG and is active in IT industry organizations. Bill earned his Bachelor of Arts degree from Queens University in Charlotte NC.
Lisa C. May
Vice President, Head of Human Resources
Lisa May has served as Head of Human Resources at AAIPharma Services and Cambridge Major Laboratories since January, 2014. She is a seasoned HR business leader with more than 25 years of experience developing and implementing people-related solutions within the pharmaceutical industry. Before joining AAIPharma, Lisa was vice president of Human Resources, Global Operations for Hospira, Inc. and has held positions of increasing responsibility at both Hospira, Inc. and Abbott Laboratories.
Lisa earned a Bachelor of Arts degree in Psychology with a Minor in Business Administration from DePauw University (Greencastle, Ind.). She is a Six Sigma Greenbelt, and is active in a number of industry organizations.
Vice President, Global Manufacturing Operations
Mr. Cortes is a Pharmaceutical Operations and Biotechnology Executive who brings over 30 years of leadership and experience in the areas of Quality, Manufacturing, R&D and overall Operations management. He has a proven record of success in small volume parenteral, API and solid oral dosage form manufacturing operations. His career progression began with DuPont Pharmaceuticals in an R&D pilot plant scale up environment, developing and implementing validation and qualification programs as well as transferring products from R&D to different manufacturing sites. He has successfully lead Global Quality organizations in large and small company environments and implemented harmonized systems across global operations. Throughout his career Mr. Cortes spent several years running operations in the Netherlands manufacturing lyophilized cytotoxic products for the US, EU and ROW. Upon returning to the US, Mr. Cortes led the turnaround of a consent decree facility for Wyeth in Pennsylvania and has held senior management positions with MedImmune, Wyeth, Cephalon, Teva and Endo Pharmaceuticals, prior to joining AAIPharma.
Mr. Cortes holds a Bachelors of Science degree in Engineering from Drexel University and has been a member and contributor to several industry associations including ISPE, PDA and Rx360.
Director, Environmental Health and Safety
Lynette joined AAIPharma and Cambridge Major Laboratories in May of 2014 serving as the Global Head/Director of Environmental Health and Safety. Lynette has over 22 years of Environmental, Health and Safety experience including 20 years in the pharmaceutical industry. Prior to joining AAIPharma Services and Cambridge Major Laboratories, Lynette spent 17 years at Amgen where she held leadership positions in Environmental Health and Safety, Risk Management and Business Continuity.
Lynette has a Bachelor of Science degree in engineering from Syracuse University. She was formally recognized for her commitment to Environmental Health and Safety as a winner of the 2009 Providence Business News “40 Under Forty” award.
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.
Dean Shirazi, Ph.D.
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, Business Operations
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, Project Management / 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.