About Pharmatech Associates: A USP Company

Scott Snyder is a proven leader with 25 years of experience in developing, implementing, and optimizing operational and financial processes. He has a successful track record in strategic executive leadership with small businesses that provide business services, consulting services, and technology services.

Snyder uses a consultative approach, drawing on his diverse professional background working in many industries, for companies of varying sizes, and in different roles.

Prior to joining Pharmatech Associates, he held executive leadership positions at TMA Direct and served as an outsourced COO/CFO for various entities. Snyder also held consulting management positions at Cizer Software, INTIEX, and PricewaterhouseCoopers.

He has consulted for the Executive Office of the President (EOP), Environmental Protection Agency (EPA), United States Postal Service (USPS), International Air Transport Association (IATA), Air Transport Association (ATA), and MCI Communications (MCI).

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 has authored more than 200 papers in industry and peer-reviewed journals and is a regular editorial and technical contributor to several industry publications. He serves on the editorial advisory boards for Pharmaceutical Manufacturing and Pharmaceutical Technology and is a founding member of the CPhI 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, San Diego.

Claudia Lin is a biotech veteran with over 30 years of experience in multi-national companies and startups in the U.S., EU and China working in life cycle biologics product development, manufacturing, and quality. A global supply chain expert, Claudia’s work focuses on phase-appropriate product development, quality management, and regulatory compliance for all biologics. She holds a PhD in cell and molecular biology from the University of California, Berkeley.

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 effectively 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.

He has extensive experience designing and implementing Quality Management Systems (QMS), primarily in startup environments for biologics, medical devices, and other emerging regulated therapeutic areas.

Rafa is dedicated to providing high-caliber, above-and-beyond service to Pharmatech’s clients and is energized by the challenge presented by each unique opportunity. He holds a B.S. in Chemical Engineering from Johns Hopkins University.

Anil Chhibbar is a seasoned biotech professional with over 14 years of experience spanning manufacturing, process engineering, technology transfer, and process development. He has held leadership roles across the cell and gene therapy sectors, including biologics, cell therapies (CAR-T & MSCs), and gene editing (CRISPR/Cas9/12a). Anil has successfully led multidisciplinary teams and managed projects supporting more than 10 clinical and 3 commercial products. His expertise includes developing and optimizing manufacturing strategies, implementing Quality by Design (QbD) principles, and advancing production platforms from proof-of-concept to commercial supply. Anil has a proven track record in process characterization, technology transfer, CMC regulatory submissions, and facility buildouts for GMP operations. He has served as a principal consultant and advisor to pre-seed biotech companies, providing strategic guidance on process development, manufacturing, and business operations.

Moria brings twenty years of quality systems, commissioning/qualification/validation (CQV), and training experience to clients in the pharmaceutical and biopharmaceutical manufacturing industry. At Pharmatech, they are a key contributor, team leader, and problem solver supporting QMS implementation and remediation, gap assessments, and CQV projects, with particular depth in guiding cell and gene therapy clients through the transition from R&D to cGMP clinical production. Moria has led facility, utility, and equipment qualification efforts for multiple cGMP production facilities, and developed training modules, including a hands-on training program to introduce learners to operating in the GMP space. They are a published author on risk-based validation and quality systems standardization, with bylines in Bioprocess Online and Pharmaceutical Online. Moria holds a B.S. in Biology from UC San Diego and is ASQ-certified as both a Quality Auditor (CQA) and Manager of Quality/Organizational Excellence (CMQ/OE). In their spare time, they keep tiny shrimps in big aquariums.

Elaine Lee has over 40 years in the biopharmaceutical and medical device industries providing Quality Assurance expertise for clinical and commercial medicinal products. She has unmatched expertise in developing, supporting, and assisting in the management of quality systems, including but not limited to, independent internal and external audits, change control, document management systems, training, customer complaint management, and product disposition, as well as assessing regulatory compliance of quality systems.

Joel brings more than 20 years of experience across the medical device and pharmaceutical industries. Throughout his career, Joel has held a range of mid-level and senior leadership roles spanning quality, regulatory affairs, sales, training, business development, reimbursement, and medical marketing. Most recently, he has supported medical device and pharmaceutical manufacturers in quality and regulatory business development roles. His prior leadership experience includes serving as Sales Manager for Alcon Pharmaceuticals, Sales Trainer for Ortho Pharmaceutical, Senior Vice President for AdvantMED, Senior Vice President for Otoharmonics, Senior Vice President for AHAA, and President/CEO of Practice Builders, an international medical marketing agency. Joel has worked with domestic and international pharmaceutical, in vitro diagnostics, and medical device companies, providing regulatory, quality, clinical, and business development support. His clients have ranged from pre-market and start-up organizations to publicly traded corporations. Joel holds a B.S. in Biology from the University of Wyoming. Outside of work, he is an active participant in U.S. Masters Swimming competitions and is the father of three children.

Richard Steiner has spent over 30 years building the pharmaceutical continuous manufacturing (CM) industry from the ground up. As Practice Lead for Pharmaceutical Continuous Manufacturing at Pharmatech Associates, the consulting arm of the U.S. Pharmacopeia (USP), he guides advanced manufacturing and Pharma 4.0 engagements for leading global pharma and CDMO organizations and directs the firm’s ICH Q13 regulatory-agency training program.

Richard’s career has tracked, and helped shape, the emergence of continuous manufacturing as a mainstream pharmaceutical technology. At Leistritz, he helped introduce twin-screw extrusion until then a chemical-industry process into pharmaceutical manufacturing, leading the business unit that established the company as the world leader in pharma extrusion. He went on to spend a decade at GEA Pharma Systems, where he led the introduction of continuous OSD (oral solid dosage) processing and advanced process control (Pharma 4.0) technologies into the U.S. and other major global markets. His work there included key industry milestones such as Pfizer’s PCMM continuous tablet platform (an ISPE Facility of the Year winner). He also led the launch of GEA’s CDC continuous direct-compression platform, which won the 2013 GEA Innovation Award.

A recognized authority on continuous manufacturing, Richard speaks regularly at leading industry conferences, including AAPS, ISPE, IFPAC, INTERPHEX, Achema, CPhI, and APV, and engages directly with regulators such as the FDA, EMA, PMDA, and ANVISA on CM policy and implementation. He is a contributor to multiple industry textbooks, including *Pharmaceutical Extrusion Technology* and *Continuous Manufacturing of Active Pharmaceutical Ingredients via Flow Technology*.

Richard holds an MBA in Corporate Finance and an MBM in Marketing & Technical Sales, both earned in Germany, along with a Dipl.-Ing. in Mechanical Engineering from the Georg-Simon-Ohm University of Applied Sciences in Nuremberg. He is fluent in German (native) and English.

Steve brings more than 25 years of entrepreneurial business development experience to his role. Since joining Pharmatech in 2021, he has helped build and strengthen key relationships across North America, Latin America, Europe, and Asia. His career includes senior business development and executive leadership roles with organizations serving the pharmaceutical industry, including drug development consulting, medicinal chemistry, protein X-ray crystallography, and CDMOs. Steve is committed to helping clients achieve first-time success in their drug development programs. He leverages his global relationship-building experience to connect clients with Pharmatech’s Quality, Regulatory, and CMC expertise. He holds an MBA from Lewis University and a bachelor’s degree from the University of St. Francis.

With over 20 years of accounting experience, Heyward Kreutzer serves as Senior Accountant at Pharmatech, where she specializes in accounts receivable, client invoicing, revenue tracking, and financial reporting. She is recognized for her accuracy, attention to detail, and commitment to maintaining efficient financial operations that support the company’s continued growth. Heyward manages project setup and billing processes, ensuring timely and accurate invoicing while overseeing collections and accounts receivable activities that help maintain healthy cash flow. She prepares and analyzes accounts receivable month-end reports, providing reliable financial data that supports operational planning and informed business decisions. Known for her collaborative approach and strong analytical skills, Heyward is dedicated to delivering exceptional service to both clients and internal teams. Her commitment to accuracy, process improvement, and operational excellence helps strengthen Pharmatech’s financial performance and contributes to the organization’s overall success.

Rosemarie Maglinte is a California-based HR Administrator with over 15 years of experience in workplace operations, onboarding, and employee engagement. She is passionate about building compliant and supportive work environments. Outside of work, she enjoys spending time outdoors and playing family board games with her husband and three children.