OUR LEADERSHIP HAS BROAD OPERATIONAL AND MULTI-FUNCTIONAL EXPERIENCE

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

Chief Executive Officer

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.

CALVIN WONG

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:

  • Basis of Design and Conceptual Design Development for U.S. and Asian GMP Pharmaceutical and Biotech Manufacturing Facilities
  • Commissioning, Qualification and Validation Program Development, Project Management, Protocol Development and Execution
  • Technology Transfer between US and International Sites
  • NDA submissions for drugs and combination drug and device products
  • Regulatory Compliance Guidance, Audits and Remediation
  • Quality Management System Development
  • Lean Six Sigma Training, Business Strategy Development and Tactical Deployment
Mr. Wong holds a B.A. in Microbiology from the University of California at Berkeley. He currently lives with his wife in the San Francisco Bay Area.

BIKASH CHATTERJEE

President and 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.

Michaela Mueller

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.

JOANNE ZONGUS

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.

WAI WONG

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.

Jorge Basso

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.

Richard Aleman

Vice President, 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.

Kerri-Anne Mallet

Vice President, 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).

Peter Rafa

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.

Barrett Fallentine

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.

Lynn C. Hansen, RAC

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).

Mustafa Abdallah

Director, 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.

Michele Levenson

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/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.  Ms. Levenson has been extensively involved in leading commissioning and qualification mission critical projects for gene therapy, pharmaceutical, and biotechnology companies. Additionally, she has been fully engaged in remediation activities of pharmaceutical and biotechnology companies that are under regulatory action specifically for Process Validation in the US and was involved in the development of policies and procedures for process validation programs deployed around the world. Ms. Levenson is a Lean Six Sigma Green Belt and Certified Project Management Professional (PMP) with a B.S. degree in General Life Sciences and a Minor in Spanish from Penn State University in State College, PA.

Shawn Inks

Validation Program Manager

Mr. Inks serves as a Validation Program Manager. He has nearly 25 years of experience in the Pharmaceutical, Biotechnology and Diagnostics industries with a diverse background in Quality, Manufacturing, Validation and Engineering. Mr. Inks started his career with a small diagnostics start-up company in Berkeley, CA  where he built a strong foundation in GMP manufacturing, validation, compliance and regulatory inspections. While there he successfully started up a new manufacturing facility and transferred all production activities. His subsequent experience at Chiron Corporation expanded his knowledge of large-scale manufacturing processes, equipment and trouble-shooting. Looking for a new challenge, he transitioned to a position in their Quality organization and spent the next ten years with Chiron & Novartis developing a strong background in all aspects of quality, compliance and regulatory inspections. His last position prior to joining Pharmatech, was managing all facility and utility qualification activities for Gilead Sciences in Foster City, CA. Throughout his career Mr. Inks has been directly responsible for the management, execution and compliance of hundreds of validation projects, including numerous capital projects totaling well over 1 billion dollars. Mr. Inks received his B.A. in Biology and Physical Anthropology from the University of California, Santa Barbara.