Meet the Experts Behind Your Success
Our consultants combine decades of industry experience with a shared commitment to innovative, compliance-driven solutions. We partner with you to navigate complex challenges, ensure regulatory success, and drive sustainable growth for your organization.
Phillip A. Minton
Lead Consultant- Quality Systems, Design Controls, Process Controls & Commercialization
Phillip is a seasoned leader with over 30 years of experience in Quality, Validation, Commercialization, Operational Excellence, and Portfolio Management. He has proven expertise in greenfield and brownfield developments, API manufacturing, and regulated facility expansions, driving initiatives from concept through CQV to commercial readiness. His track record spans start-ups, acquisitions, and Fortune 500 companies, consistently delivering measurable success.
Industry Experience: Healthcare, biotech, medical devices, pharmaceuticals (solid dose, API), life sciences (gene/cell manufacturing), food manufacturing, electronics, and automotive.
Expertise: Skilled in acquisitions, post-merger integration, and equipment/software system rollouts, consistently delivering on milestones while cutting cost and time through value-driven execution.
Experienced in full project life cycle with progressive levels of responsibility in analyzing business processes, gathering requirements, designing for functional and technical solutions, and implementing application software. A former Oracle consultant experienced with Oracle Customer Relationship Management (CRM) and Oracle E-Business Suite in the Telecommunication, Financial, Healthcare, Insurance, and the Department of Defense industry.
Industry Experience: Managed IT projects for implementing and upgrading e-Content Management Systems, MES and SCADA systems for Bio-Tech/Pharma/Medical Device companies.
Expertise: Skilled in Project Management, Application Implementation Methodology, Six Sigma, Business Requirements Analysis, Business Intelligence, Quality Assurance development, Computer Systems Validation and Security technology.
Alan Leeds
Lead Consultant- Strategic Leadership, CASCADE G&Os & Agile (SCRUM) Execution
Ben Mangawang
Lead Consultant- Business Intelligence, MES, & SCADA Validations
Alan is a strategist, entrepreneur, and motivational speaker dedicated to helping organizations achieve excellence. He holds a Master’s degree from SUNY and a Bachelor of Science from Syracuse University.
Industry Experience: Software definition, development and testing for client-specified enterprise systems.
Expertise: Skilled in Client defined needs via holistic software applications.
Heather Kauth
Senior Consultant, Quality & Process Engineering
Heather Kauth brings over 11 years of experience in the pharmaceutical and medical device industries, combining technical expertise with proven leadership in quality and process engineering. She is known for mentoring teams and driving solutions that uphold the highest standards of compliance and innovation.
Industry Experience: Heather has led quality and validation initiatives, managed capital equipment projects, and implemented risk management systems in both pharmaceutical and medical device settings. Her background includes guiding product development efforts and navigating complex regulatory landscapes with a strong focus on operational efficiency.
Expertise: Heather’s core competencies include quality systems, validation strategy, and process engineering. She brings deep technical knowledge in analytical methods, manufacturing processes, and biochemistry—from method validation and IQ/OQ/PQ to formulation development and advanced techniques like freeze drying, chromatography, and bio-reactor operation.
Julius Walker
Lead Consultant- GMP Manufacturing, Commissioning/Validations
Julius is a seasoned commissioning and validation expert with over 25 years of hands-on experience launching new products, commissioning laboratories and manufacturing facilities, and leading complex CQV (Commissioning, Qualification, and Validation) initiatives. He brings deep expertise in API manufacturing and regulated facility expansions, consistently driving projects from concept through to commercial readiness..
Industry Experience: Healthcare, biotech, medical devices, pharmaceuticals (solid dose, API) and life sciences (gene/cell manufacturing).
Expertise: Key expertise includes manufacturing systems, validation protocols, laboratory testing and execution. As a process expert Julius brings deep technical knowledge in line setup, analytical methods, manufacturing processes and line testing processes.