Our Team
Scott Cross, MS. Founder and CEO
Scott brings more than 25 years of leadership experience in the Cell and Gene Therapy (CGT) sector, spanning strategy, process development, GMP manufacturing, analytical development, CDMO oversight, fill–finish operations, and the design, construction, and commissioning of advanced cleanroom manufacturing facilities.
Following graduate training, Scott began his career at Merck Research Laboratories and Merck Manufacturing Division where he supported the manufacture and release of vaccines including the adenovirus‑based HIV gag/pol vaccine and the Hepatitis A and B vaccines. He later led the Indiana University Vector Production Facility, a National Gene Vector Laboratory (NGVL), overseeing GMP manufacturing of lentiviral and retroviral vectors, process development, quality testing and release, and the design and build‑out of the IUVPF GMP manufacturing facility.
Scott subsequently joined Cincinnati Children’s Hospital Medical Center, where he managed the GMP vector manufacturing facility, viral vector core, and aseptic processing suites. He later relocated to the University of Florida’s Florida Biologix, serving as Director of Cell Therapy, Fill–Finish, and Vector Support Operations.
Following the Florida Biologix spinout and the formation of Brammer Bio, Scott joined Orchard Therapeutics, serving as Vice President of Vector Operations. Most recently, he spent five years as Head of Gene Therapy CMC and Senior Principal at Dark Horse Consulting Group.
Driven by a commitment to rapidly and cost‑effectively advance CGT products to patients, Scott founded ATMP Consulting Group in 2025, where deep technical expertise and execution, speed, and pragmatic commercialization strategies help sponsors accelerate programs from development to market.
Contact Scott at: Scott@ATMPconsult.com
Katie Miller, PhD. Sr. Principal
Katherine “Katie” Miller is a senior biopharmaceutical executive with more than 30 years of industry experience, including over 15 years dedicated to the development and commercialization of cell and gene therapies across multiple global markets. She is widely recognized for her deep expertise in product characterization and its critical role in advancing successful regenerative medicine programs.
Katie specializes in analytical method development, validation, and technology transfer; quality control testing, and specification and assurance strategies; potency assay development, analytical comparability; regulatory responses and inspection remediation; and strategic build-vs-buy analyses for analytical capabilities. Her experience spans the full continuum of the cell and gene therapy landscape, encompasses multiple modalities in both cell therapies (Teff, Treg, CAR-T, CAR-NK, hPSC, MSC, iPSC) and gene therapies (AdV, AAV, LVV, LNP). She has supported programs throughout their entire lifecycle, from research transfer and early regulatory interactions (INTERACT, pre-IND, IND/CTA), through clinical development, PPQ and process characterization, to marketing authorization and commercial launch (BLA/MAA).
Katie’s prior roles include serving as Vice President and Head of Quality at Sonoma Biotherapeutics; Vice President and Global Head of Analytics and Quality for Biologics Development at Bayer; Vice President of Analytical Operations at Orchard Therapeutics; Principal Consultant at Dark Horse Consulting Group; and Senior Director of Analytical Development and Quality Control at Xcyte Therapies.
Her work includes developing and implementing a comprehensive assay panel for an iPSC cell therapy; serving as the analytical and comparability subject matter expert on a multidisciplinary team that successfully remediated a complete response Letter for a gene therapy BLA; leading a cross-functional gap assessment of a proposed BLA comparability strategy for a T-cell therapy resulting in a Marketing Authorization approval; providing guidance to resolve regulatory concerns related to BLA potency strategy gaps for a cell therapy; developing and transferring a novel cell-based potency assay to vector and drug-product CDMOs to support clinical trial initiation; designing and presenting an analytical comparability strategy to regulatory authorities that was accepted for a proposed BLA product configuration; conducting pre-acquisition due diligence on a portfolio of gene-modified cell therapies; and contributing to the design of a 150,000-square-foot commercial cell and gene therapy manufacturing facility.
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Malachi Wickman, MS. Principal Consultant
Malachi brings 8 years of expertise in the Cell and Gene Therapy (CGT) industry, with cross-functional experience supporting early- to late-phase cell therapy and gene therapy organizations as well as instrumentation developers and CDMOs.
More specifically, Malachi has demonstrated success supporting clients in strategic program and project management, CDMO and vendor oversight, regulatory strategy, technical writing, capacity modeling, analytical transfer, GMP CMC facility design, and technical operations.
Malachi earned a Master of Science in Chemistry from the University of Oregon, then worked as an R&D Scientist at Thermo Fisher Scientific and served as an instrumentation specialist at Anton Paar. She then transitioned to the CGT industry, spending 3 years at the American Red Cross in their Cell and Gene Therapy Solutions division as the Director of Client Relationship Management; there, she oversaw technical implementation of client programs requiring apheresis and processing, as well as the construction and implementation of a turnkey GMP cleanroom. She then transitioned to a 4.5-year tenure at Dark Horse Consulting Group.
Malachi is driven by a curiosity for science and a passion for advancing therapies to reach patients in need."
Regan Cross, BS. Marketing
Regan graduated with her BS in Marketing in 2026 from the University of South Florida (USF) and supports ATMP's online presence including this website, LinkedIn, and other marketing opportunities.