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.
Founder and Vice 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:
Chief Executive 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 has sat 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 200 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
Ms. Michaela Mueller serves as the Chief Financial Officer and Corporate Secretary with responsibility for all Finance, Accounting, Risk Management, Legal and Information Technology functions. In a career spanning 20 years Ms. Mueller brings a proven track record of strategic executive leadership in international and domestic financial management. Her career began with Wenzel Logistics GmbH Group in Austria, where she was employee number one and served in leadership positions that grew the company, across multiple periods of dynamic growth, from start-up to 250 employees. With her move to the United States, Ms Mueller entered the high-tech, life sciences industry holding a variety of senior level financial management positions in software and medical device companies. Prior to joining Pharmatech Ms. Mueller served as Director of Finance at Spinal Modulation Inc, a medical device R&D and manufacturing company, where she managed the financial reporting and control for all functional areas, the international commercial launch of their first products as well as the ongoing FDA Clinical trials in the US. With the successful completion of the US Clinical Trials, Spinal Modulation was acquired by St. Jude Medical and subsequently by Abbott Laboratories. Ms. Mueller was asked to remain on the team managing all financial reporting and control for the companies transitions and integration with St. Jude and Abbott. Throughout her career she has met the global challenges of complex business strategies in high growth market segments. Ms Mueller holds an MBA in General Management from Joseph Schumpeter Institute, Austria and certificates for continuing education programs from Stanford Graduate School of Business and the Harvard Management Mentor Program.
Vice President, Human Resources
Ms. Zongus oversees all human resources functions, including: recruitment and hiring, compensation and benefits, legal compliance, training and development and strategic planning for Pharmatech Associates. Through her accomplished career, Ms. Zongus has learned the importance of fostering an environment in which both employees and company can thrive. She joined the company as a consultant in 1995, and rapidly converted to a full-time employee. Ms. Zongus brings her expertise in finance, management information systems, project management, and human resources to the team and has previously served as Pharmatech’s Controller, VP of Finance and HR, and CFO. The past two and half decades have seen Ms. Zongus work in a variety of industries, including: hi-tech manufacturing, “Big 5” Accounting, professional services, government, transportation and construction. This combination of experience allowed her to successfully facilitate Pharmatech’s growth in the competitive regulated life sciences consulting arena. Ms. Zongus led Pharmatech’s fiscal strategies though many challenging economic cycles, culminating with a record year in 2017. In previous positions, Ms. Zongus worked for Arthur Andersen’s consulting division, Amdahl Corporation, Source Services, and The Burke Company. She graduated from the University of Santa Clara with a B.S.C. in Finance, with emphases in Accounting and Economics. Ms. Zongus, a passionate advocate for education and the arts, has served many non-profit initiatives in a leadership capacity. Currently, she focuses on supporting the needs of public education in San Mateo county.
Vice President, Regulatory Compliance
Mr. Abdallah has 20+ years of extensive experience in Quality Management Systems, IT Systems & Computer Systems Validation all in a regulated environment, working within a broad array of Life Sciences organizations. With expertise encompassing both drug sponsor and solution provider considerations Mr. Abdallah is uniquely qualified to tackle the complex challenges which form the foundation of today’s global supply chain and information management systems. Mr. Abdallah has specific experience including creation of phase-appropriate Quality Management Systems (QMS), managing the GLP-GMP and GTP-GMP transition, leading and managing 483 FDA Observation/Warning Letter remediation work, external regulatory audit program design and management including performing GxP audits in various domains. He has extensive experience in the design and deployment of GxP information systems including information master planning, software development life cycle (SDLC) management systems and GxP IT infrastructure creation. These systems are often the backbone of today’s cyber-supply chain and expertise in these systems is essential to meet the regulatory compliance requirements of today’s global marketplace. He is highly experienced with many GxP information systems implementations, including ERP, LIMS, ELN, eQMS, EDMS, MES, in either capacity of project management, validation lead, compliance oversight and even end user support. All have been successfully implemented or remediated to meet business requirements and the associated regulated requirements such as 21CFR 210/211,600, 820, 1271and Part 11 applicability, as well as, SOX 302/404 and ISO 270001.
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
Dr. Lambert has 20+ years of experience in drug and device development. His experience includes device/drug combination products, vaccines, monoclonal antibodies, recombinant proteins, peptides and small molecules for parenteral, pulmonary, solid oral, topical and transdermal dosage forms. He has expertise in Quality by Design with specific emphasis on designing and leading Risk Based QbD activities for ANDA, NDA, BLA, PMA and MDD applications. He has executive leadership experience and expertise in CMC strategies small, large, and complex large molecule modalities and in developing, formulations, processes (upstream and downstream) and analytical methods for products at all phases of drug and device development lifecycle. Dr. Lambert’s participation in academic/industry/regulatory agency collaborations throughout his career has resulted in multiple grant awards supporting the development of novel products and therapeutics. He has unique experience in having supported both development and commercial manufacturing on the drug/product sponsor side of the development process as well as from a contract service provider’s perspective. He continues to apply his industry knowledge and thought leadership to support innovative market approvals for novel technologies.
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.
Ms. Gaulding serves as our Director of Regulatory Compliance, bringing 25 years of experience in quality management systems and validation program management in Pharma, Biotech, Medical Device, and related life science industries. Drawing on her extensive background, Ms. Gaulding develops and delivers efficient and sustainable quality management systems assuring compliance with global regulatory requirements and industry best practices. Over the past five years, her consulting services have helped both start-up and industry-leading clients successfully pass regulatory inspections. Ms. Gaulding has also held Quality Management leadership positions at Mediatech, Inc. and Boehringer Ingelheim Chemicals, Inc. Ms. Gaulding is an ASQ Certified Quality Auditor and ASQ Certified Pharmaceutical GMP Professional. She holds an M.Sc. in Biotechnology from Johns Hopkins and a B.Sc. in Biology from Virginia Tech. Ms. Gaulding is actively involved in PDA, ISPE, and ASQ through co-teaching ISPE’s “Applying Quality Risk Management” course, serving as a member leader in 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. Her extensive GxP knowledge and experience with multiple regulatory authorities coupled with her passion for developing and working with people result in a proven track record of successful client collaborations to achieve their desired results.
Director, 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).
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.
Executive Director, Facility Design and Engineering
Ms. Cacciatore has over 15 years of experience in facility design, engineering and construction management. She has served in leadership positions in several multinationals including Sanofi and Genzyme. She has been responsible for leading multi-million dollar renovation projects from feasibility and conceptual design through licensure including biologic and viral vaccine facilities. She has overseen engineering of filling, packaging, and sterilization equipment, motion control and machine design including leading the technical oversight of the startup of a filling line during the 2009 flu pandemic. Allison has extensive experience in commissioning, qualification and validation and a deep understanding of the criteria to successfully implement Risk Based Validation and ASTM E-2500. In addition to operating organization experience, Ms. Cacciatore has been in consulting leadership roles for the past four years. Prior to her career in Pharma/Biotech, Allison was a consultant to the plastics and specialty chemicals industry. Ms. Cacciatore is a graduate of Lehigh University in Bethlehem, PA with a BS in Chemical Engineering, and MBA in Management.
Senior Program Manager
Ms. Levenson brings 18+ years of experience in the biopharmaceutical, pharmaceutical, and medical device/diagnostic industries with an emphasis on process, equipment, utility, facility, computer, and automation validation as well as project and people management. Ms. Levenson’s areas of expertise include equipment/facility/utility/
Executive FDA Advisor
Mr. Aleman began his career with the FDA as an investigator in Dallas, Texas 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.