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 Cambridge Major Laboratories a leading provider of comprehensive outsourcing services to the pharmaceutical and biotechnology industries.
Chief Executive Officer
Stephan brings valuable leadership experience with over 18 years’ in the pharmaceutical industry. Most recently, Dr. Kutzer served as Chief Operating Officer of Lonza, Inc. (part of the Lonza Group, a Swiss chemicals and biotechnology company). Since 2003, he has also served as Chief Operating Officer and/or President of several divisions, including Lonza Pharma Biotech Division, Lonza Custom Manufacturing, Lonza Biopharmaceuticals and Lonza Performance Chemicals.
From 1999 to 2002, he served as Site Director and Vice President of Operations of Lonza’s Bayport, Texas facilities, and in 1999, he was Director of Process Improvement at Lonza Guangzhou Ltd. Guangzhou, PR China. At Lonza Visp, he was Production and Plant Manager (1998) and Assistant Production Manager (1996) of Nicotinates. Dr. Kutzer holds a Master’s Degree in Chemical and Process Engineering and a Ph.D. in Engineering Sciences (Chemical Engineering) from the Technical University of Munich, Germany.
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.
Chief Operating Officer
Ted brings strong leadership and over 30 years of operational and management experience, the last 14 years in the pharmaceutical industry. Most recently, Ted served as the Vice President, Global Operations for the Fine Chemicals Division of Johnson Matthey, and from 2010-2013, as the General Manager for their North American API business. From 2007-2010, Ted was the Site Head for Lonza’s API Manufacturing facility in Conshohocken, PA. Prior to that, he served in various operational management positions in Johnson Matthey’s chemical, refining, and automotive business units.
Ted earned a B.S. in Chemical Engineering from the University of Notre Dame and an MBA in Finance/Production Management from St. Joseph’s University. Additionally, Ted has a management degree from the University of Michigan in Lean Manufacturing, and most recently, a certification in Negotiations from the Negotiations Institute of the Harvard Law School.
Syed T. Husain
Chief Commercial Officer
Syed brings valuable commercial leadership with over 10 years of in-depth experience in sales, business development, marketing and operations for the custom development and manufacturing of Chemical (Small Molecules, Antibody Drug Conjugates, Peptides) and Biologic (Mammalian and Microbial) APIs within the Pharmaceutical and Biotech industry. Most recently, Syed served as Head of Business Development & Business Team at Lonza responsible for the Chemical API manufacturing business.
From 2005 to 2013, he served as Director, Sales & Business Development responsible for Biologic and Chemical APIs and Head of Sales & Business Development for the Chemical API Manufacturing Business Unit also at Lonza. From 2003 to 2005, he worked in Vaccines Manufacturing Compliance at Wyeth Pharmaceuticals. Prior to that, he completed internships within Validation, Product & Process Development and Aseptic / Non-Sterile Liquids Manufacturing at Pfizer and Quality Control at Stepan Company.
Syed earned a BS in Chemical Engineering from New Jersey Institute of Technology in 2003 and an MBA from Cornell University in 2009.
Dean Shirazi, Ph.D.
Chief Scientific Officer
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, 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.