Pharmatech has assembled one of the most diverse, experienced, and professional executive teams in the industry. Our leadership team is comprised of seasoned leaders who immerse themselves into each client engagement.
Warren G. Baker is CEO of Pharmatech Associates Inc. During his 35 year career, Mr. Baker has held senior executive positions in both public and private, Fortune 100 and early-stage bio-tech and medical device companies. Additionally, he is Chairman of the Board of iTech Medical Inc., a publicly traded company focused on pain management therapies using Muscle Pattern Recognition and Magnetic Field technologies and previously served as both its COO and CEO. Mr. Baker was the COO at Advanced Research Technologies (ART) of Montreal, Quebec where he led the work on development and commercialization of optical imaging technology for the identification and diagnosis of breast cancer and the identification of optically tagged biomarkers in preclinical pharmaceutical studies. Prior to his work at ART, Mr. Baker was President and CEO of Electromed Imaging, a global leader in Cardiac Image Information Management Systems (CIIMS). During his work with both ART and Electromed, Mr. Baker was responsible for the strategic acquisition and integration of both new intellectual property and the merger of synergistic global business organizations. Mr. Baker began his career in the medical and scientific industries with Hewlett Packard spending eight years with the Biosciences/Analytical Chemistry Group and finally, 10 years with the Medical Products Group as Global Marketing Manager of the Diagnostic Cardiology Business Unit. Mr. Baker holds a BS in Biology and Chemistry from Illinois College.
Founder and Chairman
Mr. Wong has been active in the biotech, pharmaceutical, medical device, and food industries in a career spanning more than 40 years. He has held a number of management positions in operations, engineering, technical services, and validation for various biotech and pharmaceutical companies, including Syntex Laboratories. Mr. Wong has established long-term relationships with the leading pharmaceutical and biotech clients in the San Francisco Bay Area, East Coast and Asia and started his consulting firm in 1995, under the name of Pharmatech Validation Services, Inc. Since starting Pharmatech, he successfully established and implemented a corporate strategy to provide U.S. and International consulting for:
President & Chief Science Officer
He has been involved in the bio-pharmaceutical, pharmaceutical, medical device and diagnostics industry for over 30 years. Mr. Chatterjee has guided the successful approval of over a dozen new products within the U.S. and Europe and is a frequent speaker at industry and regulatory events. He has published and is a regular editorial contributor to several internationally recognized industry journals. Mr. Chatterjee has spoken and published extensively on the application of PAT, Lean Six Sigma, Quality by Design and Process Validation approaches within the regulated life sciences industry. He is an ISO 9000 certified Lead Assessor and Six Sigma and Lean Manufacturing Master Black Belt. Mr. Chatterjee has developed and transferred products and processes to satellite operations and Contract Manufacturing Organizations for much of his career. He has extensive experience with design and implementation of systems to satisfy the requirements for ICH Q8, Q9, and Q10 as well as e-pedigree and the application of risk based approaches in the area of validation. His experience in complex product and process development and technology transfer has resulted in the development of a six sigma based methodology to support the PAT initiative and has successfully tailored the principles of Lean and Six Sigma for application in the pharmaceutical R&D environment resulting in reduced program risk and reduced time to market. Mr. Chatterjee is a member of the USP National Advisory Board and is the Past-Chairman of the Golden Gate Chapter of the American Society of Quality. Mr. Chatterjee is a member of the Healthcare Information and Management System Society Technical Advisory Board and sits on several private Scientific Advisory Boards. He is a standing member of the editorial advisory board for Pharmaceutical Manufacturing and Pharmaceutical Technology, a founding member of the CPhl Expert industry Advisory Board and writes a recurring column for several magazines on industry trends and challenges. He is a frequent industry speaker and has published over 70 articles. He is also the author of "Applying Lean Six Sigma in the Pharmaceutical Industry (ISBN: 978-0-566-09204-6), July 2014 published by Gower Publishing, Mr. Chatterjee holds a B.A. in Biochemistry and a B.S. in Chemical Engineering from the University of California at San Diego.
Chief Financial Officer and Vice President of Human Resources
Ms. Zongus joined Pharmatech Associates in 1997 and currently oversees all accounting, finance, risk management, legal and human resources functions. Over the past two and half decades, Ms. Zongus has provided her expertise in finance, system designs and installations, project management and process improvement for an assortment of companies ranging from small privately held firms to which focused on providing accounting and human resource services to small emerging companies. Ms. Zongus has worked in a number of industries, including, hi-tech manufacturing, government, Big 4 consulting, transportation, construction, and professional services. The combination of Ms. Zongus' experiences has afforded her the knowledge necessary to guide Pharmatech through the ups and downs of the ever changing regulated life sciences industry and the economic environment while helping Pharmatech to improve performance, increase margins and become more competitive. Earlier in her career, Ms. Zongus, among other positions, was the manager of Financial Planning and Budgeting for The Burke Company, a Treasury Analyst for Amdahl Corporation and a Senior Consultant for Arthur Andersen & Company's Consulting Division. Ms. Zongus graduated from University of Santa Clara with a B.S.C. in Finance with emphases in Accounting and Economics. Ms. Zongus is a staunch proponent for volunteerism and a passionate advocate for education. From her youth, she has actively volunteered for a number of organizations and served in various leadership capacities. Most recently, her efforts have been focused on supporting the many needs of public education in the Foster City and San Mateo areas.
Vice President, Validation
Mr. Wong leads the commissioning, qualification and validation practice for Pharmatech's clients. Mr. Wong brings 20 years of equipment, facility and process validation experience in the pharmaceutical, medical device, and biologic industries. He has earned an international reputation for expertise in validation having demonstrated success in navigating the complex requirements of the FDA, EU and PIC/s compliance. Pharmatech was founded as a qualification and validation firm and Wong shepherds this practice area. Prior to joining Pharmatech in August 2005, Wai was the West Coast Regional Manager of Validation for Fluor Enterprises, one of the world's largest, publicly owned engineering, procurement, construction and maintenance services companies. Prior to joining Fluor in 2004, Mr. Wong was a Senior Validation Engineer at Nektar Therapeutics, formerly Inhale Therapeutic Systems, a biopharmaceutical company that develops drugs that are easier to take, safer to use, longer lasting and more effective. Between 1998 and 2001, Mr. Wong was a Project Lead for a Bay Area validation consulting company dedicated to providing expertise to the biopharmaceutical industry. Mr. Wong began his career in the biopharmaceutical industry at Genentech, Inc., considered to be the founder of the biotechnology industry. Genentech uses human genetic information to discover, develop, commercialize and manufacture biotherapeutics that address significant unmet medical needs. Mr. Wong started at Genentech working as an aseptic filling technician and worked his way up to becoming a shift lead and eventually the role of a process engineer who introduced new equipment and processes into Genentech’s fill-finish operation for both clinical and commercial manufacturing. Mr. Wong has authored multiple articles relating to the biopharmaceutical and medical device industries. He holds a Green Belt in Six Sigma and has been involved in many FMEA exercises at numerous client sites. Mr. Wong earned his B.A. in Molecular and Cell Biology with emphasis on Biochemistry from the University of California at Berkeley. He lives in the San Francisco Bay Area with his wife and children.
Vice President, Product & Process Development
Mr. Basso has more than 30 years of experience in product/process development, engineering, automation and validation of discrete and continuous processes in the pharmaceutical, medical device, IVD, and biotech industries. He has held senior management positions in both start-up and Fortune 500 companies and has managed the engineering, product and process development functions in multiple organizations throughout his career. Mr. Basso is an expert in CMC with an emphasis on integrating Quality by Design systems and principles. His expertise spans the entire product development process with particular expertise in the technology transfer process from R&D through commercialization. He has successfully led and participated in the commercial introduction of multiple products. Mr. Basso received a B.S. in Chemistry and a M.S. in Chemical Engineering from National University in Montevideo, Uruguay.
Vice President of Regulatory Compliance
Richard Aleman, is Vice President of Regulatory Compliance at Pharmatech Associates, Inc. Mr. Aleman began his career with the FDA as an investigator in Dallas, TX in 1972. He has more than 25 years Supervisory/Management experience in the regulatory and enforcement area, primarily dealing with compliance issues confronting the drug, biologic, medical device, and dietary supplement industries regarding FDA and international requirements and regulations. Twenty-Eight (28) years of FDA experience in both the field and headquarters organizations, specializing in biopharmaceuticals, drugs and medical devices, including serving as the Biologics Specialist at the FDA’s Miami Resident Post. He is bilingual with extensive international experience in assessing API, drug product, small molecule and biopharmaceutical products. He has provided expertise to the US AID, World Health Organization (WHO), the Food and Agricultural Organization of the United Nations (FAO), and United States Pharmacopeia (USP) and has served as FDA representative at international conferences in El Salvador, Venezuela, Guatemala, Philippine Islands, Canada, Argentina, Brazil, Mexico, and the Commonwealth of the Northern Marina Islands (CNMI). In addition to his FDA experience, Mr. Aleman has served as Consultant and Lead Auditor to USP for four years. Mr. Aleman is a graduate of St. Mary’s University, San Antonio, TX with a major in Biology and a minor in Chemistry.
Vice President of Clinical & Regulatory Affairs
Ms. Mallet has over 15 years of experience in fields of clinical, regulatory and quality within the life science industry. In addition to a strong background in medical devices, Ms. Mallet also has experience with combination products, in vitro diagnostic (IVD) devices, and biologically derived materials. Her background ranges from small and start-up companies to large multinational companies. Technological areas include cardiology, gynecology, urology, pulmonary, anesthesiology, orthopedics, otolaryngology (ENT), active implantable devices and general, plastic and robotic surgery. She has been instrumental in the successful application of various regulatory submissions worldwide, including, IDEs, PMAs, 510ks, De Novo applications, EU Design Dossiers and Technical Files for CE Mark, Canadian Medical Device Licenses (Class II – IV), and other worldwide submissions for countries such as Australia, Korea, Singapore, India, Mexico, Brazil, Saudi Arabia, etc. She has authored FDA Device Master Files (MAF), including one for a proprietary recombinant DNA biomaterial based on CBER guidelines, which has since been referenced in several successful 510(k) filings. Prior to joining Pharmatech, Ms. Mallet ran her own consulting practice for over six years. During this time, she has developed her expertise in regulatory strategy and clinical development. Taking a cross-functional approach, she has advised clients on regulatory pathways most fitting to business objectives. She has interfaced with numerous regulatory authorities (FDA, Health Canada, ANSM, MHRA, BfArM, etc.) and Notified Bodies (BSI, NSAI, TÜV, LNE/GMED, DEKRA), and has assisted clients in their interactions with authorities. She has been actively involved in the creation and review of industry standards, regulations and guidelines through her past involvement in EDMA (European Diagnostics Manufacturers Association). Ms. Mallet has a broad range of international experience. She has lived in worked in Austria, France and Switzerland and has traveled extensively throughout the world. She stays current on global regulatory changes through a variety of resources including industry trade organizations and a vast network of local contacts. Kerri earned her Master of Business Administration from Northeastern University and is a member of the international business honor society, Beta Gamma Sigma. She received her Bachelor of Science degree (Summa cum Laude) in Biological Sciences with a concentration in Biochemistry and Molecular Cell Biology from Fordham University. She is also an active member of Regulatory Affairs Professional Society (RAPS).
Executive Director of Project Design and Startup
Mr. Rafa joined Pharmatech in 2001 and currently serves as the Executive Director of Project Design and Startup. His focus is to engage with Pharmatech clients across the 4 spheres of services to define project scope, roles and responsibilities, and expectations prior to contract award and ensuring that the Pharmatech team integrates within the project environment. Upon receiving his degree in Chemical Engineering from the Johns Hopkins University, Mr. Rafa began his career at Pharmatech as a validation engineer. Since then, he has become a recognized leader in manufacturing facility startup and qualification, equipment qualification of solid dosage and aseptic processes, and computerized systems validation. Mr. Rafa also has extensive experience in designing and implementing Quality Management Systems primarily in the startup environment for biologics, devices, and other exciting new regulated therapeutic arenas. Mr. Rafa is dedicated to providing high caliber, above and beyond service to Pharmatechs’ clients and is thrilled by the challenge of each individual opportunity.
Director, Product & Process Development
Mr. Fallentine serves as Director of Product and Process Development. He has held director level and senior engineering in both start-up, Fortune 500, and biosimilar companies and has more than 20 years of experience in the management of biologics, process development, process engineering, CMC, and manufacturing operations. Mr. Fallentine possesses significant expertise in scale-up and reactor characterization and development of large-scale cell culture processes for clinical manufacture of monoclonal antibodies and fusion proteins. He has managed multiple cell culture technology transfers conducted at external CMO’s and played a critical role in the development of two commercially approved drugs (Kogenate, Bexxar). Mr Fallentine has also served as Engineering Lead for three clinical monoclonal antibody programs, BDS Lead for a pre-commercial biosimilar program, BDS Lead for a late-stage biosimilar program, and Process Engineering lead for a fusion protein program. Mr. Fallentine received a B.S. in Microbiology and Molecular Genetics from the University of California, Los Angeles.
Director of Regulatory Affairs
Ms. Hansen has been involved in the development and regulatory management of product programs within the pharmaceutical and bioscience industries for over 30 years. Her experience spans the drug development lifecycle starting in product development and research and continuing through to commercial launch and post market monitoring for solid dose, parenteral and combination products. She has held leadership positions in both large Pharma and virtual start-up organizations where she has successfully overseen the regulatory submission and maintenance programs for multiple products. Ms. Hansen’s expertise includes CMC , clinical and non-clinical modules and extends to both US and global regulatory filings that utilize the eCTD format. She is an active member of the Regulatory Affairs Professional Society (RAPS) certification program and currently sits on the RACB (Regulatory Affairs Certification Board).