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.
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, 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.
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.
Director Business Development Europe
Roger is a results-oriented business development professional with over 20 years experience in technical sales, marketing, and international operations relating to the pharmaceutical and fine chemical sectors. He is responsible for growing Cambridge Major’s business in the UK and Europe, as well as building Cambridge Major’s commercial API manufacturing business globally. Prior to joining Cambridge Major, Roger was Director of Business Development for Ubichem, a privately held global chemical products and pharmaceutical services company. There he was responsible for all sales and marketing of the company’s chemistry services business. In addition, he was instrumental in building the company’s global chemical trading platform. Roger brings a unique combination of business development and strategic global sourcing skills. He holds a BSc in Chemistry from the University of Birmingham in the UK.
Keith Drouet, Ph.D.
Senior Director Business Development
Dr. Drouet brings over 15 years of business development experience and has tremendous knowledge of the North America pharmaceutical and biotech marketplace. Operating from Cambridge Major’s West Coast office, an important strategic region for Cambridge Major, Dr. Drouet directs business development activities on the West Coast, Japan, and select areas of the East Coast. His responsibilities include new business development, technical proposal generation, contract negotiations, and supply/material sourcing utilizing his strong contacts in India and China. Dr. Drouet’s strong chemistry background and experience in developing new business opportunities make him a real asset to Cambridge Major, as well as gives him added credibility in the eyes of our client base; many of whom are Ph.D. scientists themselves.
Formerly Director of Business Development for Cychem Inc he focused on contract outsourcing opportunities within the Biotech and Pharma industries including API manufacturing, process R&D, combinatorial chemistry, and pharmacology. He began his career as a Research Scientist at Arena Pharmaceuticals in San Diego where he was involved in the synthesis and design of small molecules that interact with G-protein Coupled Receptors, as well as parallel synthesis of small molecules for drug discovery.
Ph.D. – Organic Chemistry; University of California, San Diego
B.S. – Chemistry; University of California, Santa Barbara
Director of API Commercialization
John brings over 17 years of experience in custom chemical and API development, and is a founding partner in Cambridge Major Laboratories. Over his tenure with the company he has been instrumental in building a dynamic team of professionals focused on project execution and delivery. John is an aggressive, hands-on manager responsible for all GMP operations, process development, scale-up, logistics and procurement activities. His responsibilities also include project management where he oversees all interdepartmental functions critical to supply of GMP materials from development through commercial manufacturing.
Prior to his role at Cambridge Major Laboratories, John was production manager for Major Laboratories, a custom synthesis startup company serving the fine chemicals sector. He was responsible for all laboratory activities including hands on synthesis, scheduling and procurement. Later, Major Laboratories merged with Cambridge Chemical form what is now Cambridge Major Laboratories. John brings significant experience in early chemical process development, scale up, and project management.
He received his BS in Chemistry from the University of Wisconsin, Oshkosh.
Gary M. Masse, Ph.D.
Director, Corporate Sustainability
Dr. Masse is a talented organic chemist with a proven ability to solve complex technical issues. In his 30+ years in the private sector, he has held positions at Imperial Chemical Industries PLC in R&D, marketing, and technology management; at Total S.A. Resins business in operations management and engineering; and at Milsco Manufacturing Company in quality management and general management.
Gary was recently named the Director, Corporate Sustainability and he is a Certified Sustainability Manager. In this role, he is responsible for the sustainability programs at both AAI Pharma and CML. Previously, he was CML’s Director of Manufacturing Technology, where he was responsible for the scale-up of processes from R&D into Manufacturing. He joined CML in 2006 as Director of Manufacturing and was responsible for validating the 1st commercial process in the Grant Drive facility.
Gary received his Ph.D. in Chemistry from the University of Windsor (Canada), and was an NSERC post-doctoral fellow at the University of Wisconsin-Madison. He is an active volunteer with Junior Achievement, and the Leukemia and Lymphoma Society, and an Adjunct Professor of Pharmaceutical Technology at Concordia University Wisconsin.
Marcel Schreuder Goedheijt
General Manager, CML Europe
Marcel joined CML Europe in september 2013 holding the position of director of operations. As of April 2014 he holds the position of general manager.
Prior to CML Europe he gained over 15 year of experience in different leading roles in the pharmaceutical and chemical industry. He is a real teamplayer, result oriented and shows a drive for change and growth. Marcel holds a PhD in organic chemistry and a MBA degree.
Paul van Oirschot
Paul joined Cambridge Major Laboratories Europe B.V. in (June) 2014. With over 25 years of all round Finance experience, Paul is a pragmatic, business control oriented Financial, focused on facilitating the business.
Prior to CML Europe, he held multiple Finance positions in various types of industry, amongst which are pharmaceuticals, chemicals and automotive. In most of those roles Paul was the local Finance Manager of the Dutch / European subsidiary of the International Parent. Paul graduated from Hogeschool Brabant and holds a Bachelor’s degree in Business Economics.