A complex product development journey demands people who are up to the challenge.
Our teams draw on decades of experience to serve the complex needs of pharmaceutical manufacturers and regulated life science companies.
Calvin Wong has been active in the biotech, pharmaceutical, medical device, and food industries for more than 40 years, in operations, engineering, technical services, and validation management for many biotech and pharmaceutical companies, including Syntex Laboratories. Wong founded Pharmatech Validation Services in 1995 to work with the leading pharmaceutical and biotech clients in Asia and North America, providing basis of design and conceptual design development for GMP pharmaceutical and biotech manufacturing facilities, comprising commissioning, qualification and validation program development, project and protocol development, technology transfer, NDA submissions for drugs and combination products, regulatory compliance guidance, audits and remediation, QMS development, lean six sigma training, business strategy development and tactical deployment. He holds a B.A. in microbiology from the University of California at Berkeley, and lives with his wife in the San Francisco Bay Area.
Chief Executive Officer
Bikash Chatterjee has worked in the bio-pharmaceutical, pharmaceutical, medical device and diagnostics industry for over 30 years, guiding the successful approval of a dozen new products within the U.S. and Europe. Chatterjee has developed and transferred products and processes to satellite operations and CMOs throughout his career, designing and implementing systems to satisfy the requirements for ICH Q8, Q9, and Q10, e-pedigree, risk-based validation, and developing a six sigma-based methodology to support the PAT initiative. He is an ISO 9000 certified lead assessor and six sigma / lean manufacturing master black belt. Chatterjee is a member of the USP national advisory board, past chairman of the Golden Gate Chapter of the American Society of Quality (ASQ. Chatterjee is a regular editorial contributor to several industry journals, serves on the editorial advisory board for Pharmaceutical Manufacturing and Pharmaceutical Technology, and is a founding member of the CPhl expert industry advisory board. Chatterjee is the author of "Applying Lean Six Sigma in the Pharmaceutical Industry” (ISBN: 978-0-566-09204-6). He holds a B.A. in biochemistry and a B.S. in chemical engineering from the University of California at San Diego.
Chief Operating and Financial Officer
Michaela Mueller is responsible for Pharmatech’s finance, accounting, risk management, legal and information technology functions. Throughout her career she has met the global challenges of complex business strategies in high growth market segments and has worked in international and domestic financial management for over 20 years. Her career began with Wenzel Logistics GmbH Group in Austria, where she was employee number one and served in leadership positions across multiple periods of dynamic growth, from start-up to 250 employees. Prior to joining Pharmatech Associates. Mueller served as Director of Finance at Spinal Modulation Inc., a medical device R&D and manufacturing company, managing the financial reporting and control for all functional areas, and the international commercial launch of their first products and FDA clinical trials in the U.S. With the successful completion of the U.S. clinical trials, Spinal Modulation was acquired by St. Jude Medical and subsequently by Abbott Laboratories. Mueller was asked to remain to manage all financial reporting and control for the company’s transitions and integration with St. Jude and Abbott. She holds an MBA from Joseph Schumpeter Institute, Austria, and professional certificates from the Stanford Graduate School of Business and the Harvard Management Mentor Program.
STEPHANIE GAULDING, CQA, CPGP
Stephanie Gaulding has over 25 years working with quality management systems and validation program management in the pharmaceutical, biotech, medical device, and related life science industries. She develops and delivers efficient and sustainable quality management systems assuring compliance with global regulatory requirements and industry best practices to help start-up and industry-leading clients pass regulatory inspections and achieve their desired results. Gaulding has held quality management leadership positions at Mediatech and Boehringer Ingelheim Chemicals. She is an ASQ certified quality auditor and ASQ certified pharmaceutical GMP professional. Gaulding is actively involved in PDA, ISPE, and ASQ through co-teaching ISPE’s “Applying Quality Risk Management” course, as a member leader in the ASQ Human Development and Leadership Division, participating in the certified pharmaceutical GMP professional exam development process, and serving on the PDA member newsletter editorial committee. She holds a M.Sc. in biotechnology from Johns Hopkins and a B.Sc. in biology from Virginia Tech.
Vice President, Validation
Wai Wong has over 20 years of equipment, facility, and process validation experience in the pharmaceutical, medical device, and biologic industries, and has earned an international reputation for expertise navigating the complex requirements of the FDA, EU and PIC/s compliance. Prior to joining Pharmatech in August 2005, Wong was the West Coast regional validation manager for Fluor Enterprises, and a senior validation engineer at Nektar Therapeutics, formerly Inhale Therapeutic Systems. He began his biopharmaceutical industry career at Genentech as an aseptic filling technician and was promoted to a process engineer role responsible for introducing new equipment and processes into Genentech’s fill-finish operation for both clinical and commercial manufacturing. Wong has authored multiple articles relating to the biopharmaceutical and medical device industries. He is a six-sigma green belt has been involved in many FMEA exercises at numerous client sites. He holds a B.A. in molecular and cell biology with emphasis on biochemistry from the University of California at Berkeley.
ADAM LAMBERT Ph.D.
Vice President, Product & Process Development
Dr. Lambert has over two decades of experience in the research, development, and analysis of pharmaceutical products, from pre-clinical phases through NDA/BLA submission. He has developed a wide range of novel and technically challenging pharmaceutical products—small-molecule and biologics—and held leadership roles in the pharmaceutical industry. Lambert’s key accomplishments include the development of pulmonary delivery of proteins and stabilization of monoclonal antibodies (ProMaxx® microsphere technology), and the first manufactured vaccine patch (E coli vaccine) for human trials (Phase I/II/III). He holds a Ph.D. in chemistry from the University of Akron in Ohio, and a B.S. in biochemistry from State University of New York College at Plattsburgh.
Vice President, Regulatory Compliance
Drawing from a 30+-year career in quality and leadership roles across global companies in the pharmaceutical industry, Mike Porter has extensive GxP knowledge in the areas of medical devices, manufacturing, laboratory, and clinical trials. He has honed a collaborative approach to implement efficient, effective, and sustainable quality management system solutions that are compliant with global regulatory requirements and industry best practices— appropriate whether targeting commercial, start-up, or clinical operations. Porter has held leadership positions at Eli Lilly & Company, Myriad Genetics, and PPD (Pharmaceutical Product Development) in addition to his consulting experience. He is actively involved in ISPE through co-teaching ISPE’s “Applying Quality Risk Management” course and is a member of ASQ. He holds a M.Sc. biomedical engineering from Clemson University, and a B.Sc. engineering science and mechanics from Virginia Tech.
Executive Director, Facilities Design and Engineering
Allison Cacciatore has over 15 years’ experience in facility design, engineering, and construction management. Serving in leadership positions in several multinationals including Sanofi and Genzyme, she has been responsible for leading multimillion-dollar renovation projects from feasibility and conceptual design through licensure for biologic and viral vaccine facilities. She led technical oversight in the startup of a filling line during the 2009 flu pandemic responsible for the engineering of filling, packaging, and sterilization equipment, motion control and machine design. Cacciatore has deep knowledge of the criteria to successfully implement risk-based validation and ASTM E-2500, and extensive experience in commissioning, qualification, and validation. In addition to her operating organization proficiency, Cacciatore has been in pharma and biotech consulting leadership roles for many years and was a consultant to the plastics and specialty chemicals industry. She holds an MBA in management and a B.S. in chemical engineering from Lehigh University in Bethlehem, Pennsylvania.
Executive Director of Project Design and Startup
Peter Rafa serves as executive director of Project Design and Startup. His focus is to engage with Pharmatech clients to define project scope, roles and responsibilities, and expectations prior to contract award, ensuring that the Pharmatech team integrates within the project environment. Rafa began his career at Pharmatech in 2001 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. Rafa has extensive experience in designing and implementing quality management systems (QMS) primarily in the startup environment for biologics, devices, and other new regulated therapeutic arenas. He is dedicated to providing high caliber, above and beyond service to Pharmatechs’ clients and is thrilled by the challenge of each individual opportunity. He holds a B.S. in chemical engineering from Johns Hopkins University.
Director, Business Development
Greg Downs joined Pharmatech Associates bringing 20 years’ experience in the contract pharmaceutical, biotech, and medical device industry. He has a background as an analytical chemist and a passion for helping companies find the most correct path to successfully develop therapies for patients. Downs has been involved with the clinical and commercial development processes for numerous products, from discovery through commercial launch, interacting with key industry personnel globally within almost every aspect of pharmaceutical development. Downs augments the Pharmatech Associates team by liaising with current and potential clients to determine the proper resource within the Pharmatech Ecosystem for solutions to the problem at hand. He graduated magna cum laude from Campbell University, North Carolina, with a B.S. in biology with additional emphasis in chemistry and pharmaceutical sciences.
LYNN C. HANSEN, RAC
Director, Regulatory Affairs
Lynn 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 successfully overseeing the regulatory submission and maintenance programs for multiple products. Hansen’s expertise includes CMC, clinical and non-clinical modules and extends to both U.S. and global regulatory filings that utilize the eCTD format. She is an active member of the Regulatory Affairs Professional Society (RAPS) certification program and sits on the RACB (Regulatory Affairs Certification Board).
Director, Product & Process Development
Barrett Fallentine has more than 20 years’ experience in the management of biologics, process development, process engineering, CMC, and manufacturing operations. He has held director level and senior engineering positions in start-up, Fortune 500, and biosimilar companies. Fallentine is an expert 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 CMOs and played a critical role in the development of two commercially approved drugs (Kogenate, Bexxar). Fallentine has served as engineering lead for three clinical monoclonal antibody programs; BDS lead for a pre-commercial biosimilar program, and for a late-stage biosimilar program; and process engineering lead for a fusion protein program. He received a B.S. in microbiology and molecular genetics from the University of California, Los Angeles.
Director, Program Management
Michele Levenson has over 20 years’ experience in the biopharmaceutical, pharmaceutical, and medical device/diagnostic industries, with an emphasis on process, equipment, utility, facility, computer, and automation validation and project and people management. Levenson’s areas of expertise include equipment/facility/utility/automation commissioning & qualification, quality management systems, statistical analyses, process design, and process validation. Her expertise spans solid dose manufacturing delivery systems to aseptic biotech processes and drug delivery systems. Throughout her career she has been involved with process and technology transfers, process optimization and redesign projects, and cell culture fermentation operations. Levenson is extensively involved in leading commissioning and qualification mission critical projects for gene therapy, pharmaceutical, and biotechnology companies. She is often engaged in remediation activities for pharmaceutical and biotechnology companies that are under regulatory action specifically for Process Validation in the U.S. and has been involved in the development of policies and procedures for process validation programs deployed around the world. Levenson is a lean / six sigma green belt and certified project management professional (PMP). She holds an executive MBA from Saint Mary’s College of California, and a B.S. degree in general life sciences with a minor in Spanish from Penn State University.
Kathleen Mertens has an extensive background in accounting in healthcare and customer service. She managed accounting functions at a prominent printing company for 20+ years before joining Pharmatech Associates in 2006. A key cultural attribute at Pharmatech is being in service to others, and Mertens has built a customer-centered accounting team devoted to timely, accurate communication and information sharing. She champions change and has been instrumental in streamlining infrastructures that provide timely insight to projects, accounting, and management. Mertens is a San Francisco Bay Area native who believes that every day is both a gift and an opportunity. She graduated cum laude with a B.S. in finance and business administration from Notre Dame de Namur University.
Director, Sales & Marketing Communication
Janette Buechler has over 20 years of experience in marketing and event planning and is responsible for Pharmatech's marketing department and internal and external communication. Buechler is a San Francisco Bay Area native, a member of the American Marketing Association, and an active member of ISPE. She studied business administration with a concentration in marketing at San Jose State University and is inspired by the challenge of building a company brand, the power of social media, and the importance of a professional network.