Team
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Our Principal Consultants
Experienced, hands-on partners offering scalable, risk-based compliance support tailored to real-world operations.
Kristopher Le, PharmD
CEO & Founder
Kristopher is the founding member of Amicus and serves as a Principal Consultant specializing in operational strategy, process optimization, quality remediation, and validation for FDA-regulated organizations. He works with GMP organizations to design scalable systems that align regulatory compliance with business performance.
He regularly partners with executive teams to strengthen operational discipline through structured validation, risk-based quality systems, and streamlined processes that reduce compliance burden while improving operational visibility. His approach centers on building durable systems that support both regulatory confidence and operational efficiency across the product and facility lifecycle.
Focus Areas
- Process Optimization & Operational Efficiency
- Validation Strategy & Lifecycle Validation Programs
- GMP Quality Systems & Regulatory Infrastructure
Don Carter
Validation Principal
Don serves as Director of Validation at Amicus, leading facility commissioning, equipment qualification, and process validation projects for FDA-regulated manufacturers and 503B outsourcing facilities. With over 15 years of industry experience spanning formulation, validation engineering, and quality operations, he brings both technical depth and practical execution to complex GMP environments.
Prior to joining Amicus, Don held leadership roles within sterile manufacturing operations, where he oversaw validation programs and supported production in highly regulated settings. His experience includes sterilization validation (dry heat and moist heat), temperature mapping, equipment qualification, and quality system support aligned with FDA, USP <797>, and USP <800> requirements.
Don is known for building validation programs that are technically sound, inspection-ready, and operationally realistic.
Focus Areas
- Equipment Commissioning & Qualification (IQ/OQ/PQ)
- Sterilization & Thermal Validation
- 503B Process & Facility Validation
Jamie Duncan
Quality Assurance Principal
Jamie brings nearly a decade of experience in pharmaceutical quality, compliance, and operations within highly regulated environments. She previously pursued doctoral studies in Criminology at the University of South Carolina, where she developed strong analytical and research skills that she now applies to complex quality and compliance challenges in the pharmaceutical industry.
She holds several professional certifications, including ASQ Certified Quality Auditor (CQA), ASQ Certified Manager of Quality/Organizational Excellence (CMQ/OE), and a Lean Six Sigma Green Belt (LSSGB). Jamie enjoys identifying practical ways to strengthen quality systems, streamline processes, and support teams in achieving consistent, compliant operations.
Outside of work, she volunteers and fosters with local animal rescues, a cause she’s passionate about and a meaningful way she gives back to her community.
Focus Areas
- Quality System Development & Optimization
- Internal Audits & Compliance Readiness
- Process Improvement & Operational Excellence
Becca Mitchell, PharmD
Quality Assurance & Regulatory Affairs Principal
Becca was a founding member of Team Amicus in 2019 and stepped into the role of Principal Consultant in 2026. A graduate of the University of Arkansas for Medical Sciences College of Pharmacy, she is licensed in 17 states and brings both regulatory depth and hands-on manufacturing leadership to her clients.
Appointed by Governor Asa Hutchinson, Becca served six years on the Arkansas State Board of Pharmacy, including a term as Board President. Combined with a decade in executive leadership at an FDA-registered sterile and non-sterile drug manufacturing facility, she offers a rare dual perspective—understanding how regulators think and what it takes to run compliant operations day to day. She has first-chaired dozens of FDA, DEA, state board, and accreditation inspections.
Becca focuses on building right-sized, practical quality systems that support clinical and commercial programs across the product lifecycle.
Focus Areas
- GMP Quality Systems & Regulatory Strategy
- Inspection Readiness & Audit Leadership
- Clinical & Commercial Compliance Support
Ready To Partner for Lasting Quality Solutions?
Let's discuss how Amicus can support your organization's compliance, validation, and quality objectives. Whether you're launching a new facility, remediating FDA findings, or building quality systems—we're here to help.