Cambridge Major boasts an industry-leading record for execution and delivery of the most challenging drug development and manufacturing projects. Our senior management team is experienced and highly motivated, epitomizing the entrepreneurial spirit and drive that is so critical to ensuring success in the drug development process.
Brian has been involved in technology-based companies throughout his 20 year career. His strong customer focus, combining technical and business expertise, has helped drive Cambridge Major Laboratories to its current position as the country’s leading pharmaceutical chemistry services organizations. He has overseen the business aspects of CML for the past 9 years, during which time the company has undergone average growth rate of greater than 20% per year. In his previous role as Chief Business Officer, Brian was responsible for developing and implementing corporate development strategies for the company, including sales and marketing, forecasting, contracts/legal issues, and project management. He brings significant industry experience in creating collaborations and deals aimed at win/win solutions. He has been involved in several pharmaceutical contract chemistry organizations over the past 15 years ranging from startups to large Contract Manufacturing Organizations.
Prior to joining Cambridge Major, Brian managed business development activities in North America for Rhodia ChiRex focusing on the company’s technology portfolio and the emerging pharma sector. Prior to Rhodia ChiRex, he helped form the startup company, Universal Pharma Technologies, where he was responsible for all technical sales and marketing efforts. The company was later acquired by Johnson Matthey. Brian started his career with petrochemical giant UOP where he was a R&D chemist, then later moved into the specialty chemicals group in various marketing roles.
He received his MBA from the Stuart School of Business, Illinois Institute of Technology, and a BS in Chemistry from Northern Illinois University.
Brian has served on the Board of Directors of the Wisconsin Biotechnology and Medical Device Association, and is active in several industry organizations.
Mark is an accomplished business leader with over 20 years of experience in leading global finance and information technology organizations within technology-based companies. He is responsible for establishing financial and operational processes to support global growth, while ensuring the highest standards of corporate governance. Prior to joining Cambridge Major, Mark was the CFO of GE Healthcare’s US Diagnostic Imaging Business. There he was responsible for developing strategic plans and leading the commercial organization in executing in the US market place. Mark also held global Controller positions in both GE Healthcare and GE Energy, responsible for technical accounting and reporting matters as well as compliance under the Sarbanes-Oxley Act.
Mark is the former CFO of Taconic, Inc., a global industrial manufacturing company, where he led the implementation of a global ERP system. Mark brings a unique combination of financial expertise and overall business leadership skills. He holds a bachelors degree in accounting from Siena College in upstate N.Y. and is a CPA and former manager with audit firm KPMG.
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.
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.
Rick is an accomplished leader with over 30 years of experience in manufacturing. He is responsible for all plant scale manufacturing operations within the organization, as well as all engineering and EHS functions. Prior to joining Cambridge Major, Rick served as the St. Louis Site Director for Covidien, a global healthcare products company, where he was responsible for the company’s largest API plant of about 900 employees. He led all aspects of the manufacturing operations, and regulatory compliance of the resident Research and Development operations, as well as, Logistics and Quality support of a remote API facility.
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.
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.
Bob is responsible for directing the Quality Assurance and Regulatory Affairs at CML-US. He has a broad range of experience in developing, maintaining, and implementing GMP documentation and control from initial clinical materials through commercialization of Active Pharmaceutical Ingredients. Over his career, he has authored and successfully filed a dozen Drug Master Files, and has contributed to dozens of IND and NDA submission documents. He has also participated in numerous successful FDA and client audits of the Company’s facilities and systems. Prior to joining Cambridge Major, Bob worked for the startup company, Major Laboratories where he was a production chemist. As such Bob brings tremendous perspective to the Quality Unit as he understands the chemistry behind the documentation. He received a BS in Biochemistry from the University of Wisconsin, Milwaukee.
Keith 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, Keith 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. Keith’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
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.
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.
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 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 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.
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
From Discovery through commercial manufacture of active pharmaceutical ingredients – We Deliver
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