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.
Vice President of Quality Assurance
Gary joined Cambridge Major Laboratories, Inc. in 2013 as Vice President, Quality Assurance. He is a seasoned quality professional and has more than 19 years in the pharmaceutical industry including roles in R&D, Quality Control, Validation, Quality Assurance and Compliance. Gary joins Cambridge Major Laboratories from AAIPharma Services. Prior to joining AAIPharma Services, Gary was the Vice President of Quality at EI Pharmaceutical Solution Works. He has also previously held management positions at Teva and Covidien.
Gary has a B.S. in Chemistry from Fordham University in New York.
Prasad Raje, Ph.D.
Vice President, API Development and Manufacturing
Dr. Raje comes to Cambridge Major with 20 years of pharmaceutical industry experience and a proven track record of solving the most complex chemistry challenges relating to the development of API’s, solid state chemistry, formulation development, and analytical chemistry. His in-depth knowledge across the entire drug development process will help guide development programs from early pre-clinical through to commercialization, with a focus on the regulatory aspects of the development of new drugs including the Quality by Design (QbD), and the new ICH Q11 requirements relating to APIs.
Prior to joining CML, Dr. Raje held the position of President of Smithers Pharma Services, a CRO with expertise in analytical services, pharmaceutical R&D, and agrochemicals. Prior to Smithers Pharma, Dr. Raje was promoted through many roles with AMRI, initially as Section Head, Chemical Development, and progressing to President and Managing Director of AMRI India. He started his career as a Senior Research Scientist at Abbott Laboratories. Dr. Raje holds a Ph.D. in Organic Chemistry from Auburn University.
Peter Van Tilburg
President CML Europe
Peter Van Tilburg has built Cambridge Major Laboratories Europe (formerly ChemShop) into one of the leading chemistry development organizations, serving the European pharmaceutical market. He co-founded the ChemShop organization in 1999, and under his leadership invested in state of the art facilities, experienced personnel, and instilled “the right culture” in his organization that now boasts an industry-leading reputation for service and delivery. He brings an energy and focus to the business that is rarely seen in this industry today.
Prior to ChemShop, Peter spent 11 years in the DSM organization, most recently in chemical process development at the DSM Venlo facility where he was responsible for managing project development from R&D to Commercial scale manufacturing.
Prior to that, he worked for 5 years as a medicinal chemist at DSM research.
VP of Information Technology, Chief Information Officer
Joe comes to Cambridge Major with over 25 years of IT Management experience. He is responsible for the strategic IT investments and implementations for Cambridge Major in the US and Europe. Earlier in his career, Joe worked for LSI Logic, a semiconductor company, working out of their Munich, Germany facility. After relocating back to Wisconsin, Joe held the position of Chief Information Officer for Schwarz Pharma based in Mequon, WI. Previous to joining Cambridge Major he was Vice-President of IT at DDN, and has also been an Independent Consultant in the Healthcare Industry. He holds a BS degree in Computer Science from DeVry University and an MBA from Wake Forest University.
Mark Sawicki, Ph.D.
Chief Business Officer
Dr. Sawicki has over 15 years of experience driving results within the life science vertical. He has held key leadership positions and built scalable, highly effective sales and marketing operations in global environments. As CML continues on a high growth trajectory, it is imperative that our organization be positioned to support the rapid changes accompanying any successful company like CML; Dr. Sawicki will lead the efforts to ensure we are aligned across all geographies and service offerings, and to position CML for continued, sustainable growth.
Prior to joining CML, Dr. Sawicki held positions of Global Vice President, Business Development at CMC Biologics A/S, as well as Vice President, Business Development – Europe at AMRI. Dr. Sawicki earned a Ph.D. in Structural Biology from the State University of New York at Buffalo School of Medicine and Biomedical Sciences and conducted his graduate training at the Hauptman Woodward Medical Research Institute. He earned a B.S. in Biochemistry from State University of New York at Buffalo.
Rita Cooney, Ph.D.
Director of Analytical Sciences
Dr. Cooney is highly competent and successful executive leader in Analytical Research and Development. She has held steadily increasing roles of responsibility and advancement over the past 25 years, from bench scientist to executive management positions. Her work has been in the areas of fine chemicals, specialty chemicals, and brand and generic pharmaceuticals. Over her career, she has focused on all analytical activities associated with API and Drug Product method development/validation, cleaning, stability studies, and setting specifications associated with the development and manufacture of new solid and liquid dosage form generic drug products. She has a solid breadth of development experience across many areas of pharmaceutics, including drug substance, excipients, solid and liquid (including sterile) drug products, and associated regulatory filing strategies.
Rita is responsible for leading the company’s analytical services organization which includes Analytical R&D, Quality Control, and Stability. She will also be instrumental in associated regulatory filings to support client IND, NDA, and ANDA submissions. Prior to joining CML, Dr. Cooney held the role of Sr. Director of Analytical R&D at Qualitest. Dr. Cooney has also previously served as Sr. Manager of Analytical R&D for Pharmaceutical Products at Hospira and DSM Pharmaceuticals. She started her career as a Research Chemist at American Cyanamid. She earned her Ph.D. in Analytical Chemistry from Georgia Institute of Technology.
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.
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 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.
Project Director Europe
In his current role, Bernd Vergouwen manages a wide variety of projects for Cambridge Major Europe. His responsibilities involve procurement, logistics, timeline development, technical client communication, and of course helping to solve technical issues. He has an excellent reputation with customers for ensuring projects are on-time and on-budget, and that all technical information flows optimally.
Bernd has a broad range of experience in medicinal chemistry and process development from laboratory to pilot plant scale in both GMP and non-GMP environments. In addition, he has managed process validation activities, and has experience in the generation of Drug Master Files (eCTD) and IND submission documents.
Prior to joining ChemShop, he was with Tibotec (a Johnson & Johnson company) as a medicinal chemist in charge of the initial scale-up process R&D work. At Tibotec he was a co-inventor in several patents (Broad spectrum substituted benzisoxazole sulfonamide HIV protease inhibitors). Prior to that he worked at Janssen Pharmaceutica, Belgium as a medicinal chemist for 6 years. Bernd’s experience, covering the wide range from medicinal chemistry to pilot-plant scale-up, ensures that our client’s projects will be well managed and he is a real asset to the company.
Organic Chemistry (Antwerp) and M.S. Organic Chemistry at the University of Cologne.
Erwin Warmerdam, Ph.D.
Director of Chemistry, Europe
Erwin Warmerdam has been with Cambridge Major Laboratories Europe (formerly ChemShop) since it’s inception in 1999. He has helped grow the business, providing technical leadership and oversight, as well as key project management responsibilities.
His pragmatic view on the chemistry combined with an eye for detail and focus on delivery has resulted in very successful scale-up of a significant number of key projects moving the company well beyond the business plans in the early years. More recenlty he has established a number of key strategic accounts (large multi-nationals and biotechs) where Cambridge Major Europe is the preferred development partner.
Prior to ChemShop, Erwin has worked for Syncom BV, a fast growing CRO in the Netherlands. There he worked on medicinal chemistry and PR&D projects. Prior to that completed a one year post-doc at the University of Poitiers, France, where he worked on the synthesis of annonaceous acetogenins. His Ph.D. research was in the field of synthesis and application of chiral cyanonhydrins.
PhD. Organic Chemistry, University of Leiden
MSc. Chemistry, University of Leiden
Remy Litjens, Ph.D.
Project Manager, Europe
Remy Litjens, Ph.D.,
Remy Litjens joined Cambridge Major Laboratories Europe in 2007 and has since then managed a wide variety of chemical-pharmaceutical development programs including GMP scale up of Active Pharmaceutical Ingredients for all phases of clinical trials. He has over 10 years of experience in synthetic organic, medicinal and process chemistry and combines this with relevant experience regarding ICH/EMA guidelines and well developed project management and communicational skills.
Remy has been instrumental in advancing the company’s organization and services with the aim to continuously improve on accommodating customer needs. Remy translates his strong customer focus into a hands-on and aggressive, yet informal and no-nonsense management style, thereby stimulating his team to leadership and technical excellence.
Prior to CML, Remy worked as a team leader in the medicinal chemistry department of Organon Biosciences (now Merck, Sharp and Dome) where he oversaw and participated in preclinical research and development activities towards novel medicines.
Remy holds a PhD in synthetic organic chemistry from Leiden University where he worked in the group of Prof. dr. Jacques van Boom specializing in advanced carbohydrate chemistry.
Q.A. Manager, Europe
Marie-José is a conscientious professional who focuses to meet the quality standards set by Cambridge Major Europe and our customers. Her attention to detail, and knowledge of quality and regulatory issues relating to the drug development process bring the best in her work as Quality Assurance Manager. She is a key person within the Cambridge Major Europe organization and encourages teamwork and group participation with all of our employees.
Over the last 5 years her contribution led Cambridge Major Laboratories Europe into one of the leading chemistry development organizations, serving the European pharmaceutical market.
Master of Science, Organic Chemistry, Nijmegen University
Bachelor of Science, Chemistry, Fontys University of Applied Sciences, Eindhoven