Founder & Principal Consultant
Mike is the Founder and Principal Consultant of CompliScience Solutions, LLC, supporting biologics, cell and gene therapy programs, CDMOs, and 503B outsourcing facilities.
He brings decades of hands-on experience across biopharmaceutical manufacturing, CDMO operations, and academic cGMP facilities, with prior leadership roles at organizations including Wyeth Vaccines, Genencor International, the University of Rochester cGMP Stem Cell Facility, GenCure, Scorpius Biomanufacturing, and Regenerative Science.
Michael has led the design, construction, and startup of multiple cGMP facilities, along with process development, analytical strategies, quality systems, and validation programs (CQV). His experience spans early-stage development through clinical and commercial readiness, with a focus on building systems that are both technically sound and operationally practical.
His approach emphasizes science-based, risk-driven decision-making—aligning facility design, process understanding, and regulatory expectations from the outset to prevent downstream compliance gaps. The result is scalable, inspection-ready systems that perform in real-world operations.
He holds an M.S. in Biochemistry from SUNY Binghamton and a B.S. in Biology from SUNY Albany.
Principal Consultant: Quality Control & Analytical Sciences Leader
Autumn Stroud is a Quality Control and Analytical Sciences leader with over 20 years of experience in biologics, diagnostics, and cGMP laboratory operations.
She has led QC laboratory build-outs, analytical method development and validation, environmental monitoring programs, and stability studies across both CDMO and commercial environments. As Manager of Quality Control at a plasmid DNA CDMO, she built QC operations from the ground up, including equipment qualification, LIMS/Empower implementation (21 CFR Part 11), and EMPQ execution to support facility qualification and inspection readiness.
Previously, Autumn led assay development at Scorpius Biomanufacturing, supporting recombinant proteins, monoclonal antibodies, and vaccines, and held roles at Ortho Clinical Diagnostics and SA Scientific, developing and launching diagnostic assays.
At CompliScience Solutions, she supports clients with QC lab design, environmental monitoring programs, analytical method development and validation, stability programs, and investigation/CAPA systems, delivering science-based, inspection-ready solutions.
Autumn is a Six Sigma Green Belt and holds a B.S. in Biotechnology from Rochester Institute of Technology.
Senior Advisor: Process & Analytical Development
Christopher Barnett is a senior biomanufacturing executive with over 30 years of experience in process development, technology transfer, and commercialization of biologics, cell therapies, and enzyme-based products.
He has led process and analytical development organizations across CDMOs and commercial biotech, most recently as Senior Director and Head of Process & Analytical Development at Scorpius Biomanufacturing. There, he advanced client programs from early development through clinical readiness, building scalable, cGMP-compliant processes and reducing technical risk.
Previously, at GenCure, he led process development and tech transfer for cell therapy programs, supporting scale-up and transition into clinical manufacturing. He also spent nearly three decades with Genencor/Danisco/DuPont Industrial Biosciences, leading global teams in product development, commercialization, and technical operations.
Chris brings deep expertise in upstream and downstream development, protein purification, analytical methods, scale-up, and DOE-driven optimization. He is particularly valued for aligning technical strategy with business outcomes—helping organizations move efficiently from concept to compliant, inspection-ready manufacturing.
He holds an M.S. in Chemical Engineering from Stanford University and a B.S. in Genetics from the University of California, Davis.
