Gary is an analytical biochemist with approximately twenty-five years of experience in the biotech and pharma industries. He started his career at Amgen as a bench scientist, which progressed to product technical lead for development and commercial support of several large molecule products, including cytokine, glycoprotein and monoclonal antibody therapeutics. Prior to joining Neva in 2021, Gary worked as a consultant for four years with several virtual, medium and large company clients at various stages in the clinical development cycle to complete CMC-related analytical projects, while expanding his experience into vaccine, oligonucleotide and cellular therapy products. This work included evaluation, selection and technical oversight of contract testing laboratories for development and validation of biochemical and bioanalytical methods, development and execution of product characterization and/or comparability strategies, data interpretation and auditing, problem solving and troubleshooting, analytical method and technology transfer, and authoring of regulatory filings. Gary earned bachelor’s degrees in Biochemistry, and Molecular, Cellular and Developmental Biology (MCDB) from the University of Colorado-Boulder.

Tracey is an accomplished analytical chemist and leader with eighteen years of experience. She is an expert in an array of analytical techniques including Karl Fischer titrations, liquid chromatography and dissolution. Through her tenure in the pharmaceutical industry she brings extensive knowledge in USP methods, cGMPs, SOPs, laboratory compliance and laboratory safety. In her previous roles she started up GMP laboratories and was leading laboratory lean initiatives. As the Laboratory Manager at Neva she brings her passion for lab support and improvement to the daily operations continuing to build Neva’s efficiency and capacity. Tracey received her degree in Biology and Chemistry from Metropolitan State College of Denver.

Samantha Johnson has over 10 years of experience in cGMP manufacturing and testing as a Quality professional in biopharmaceutical contract manufacturing. During her tenure she has worked in a wide variety of phases of the drug manufacturing process including research and development, process development, tech transfer, Phase 1 and Phase 2 clinical manufacturing and testing as well as commercial level. She has developed and implemented quality and document management systems that span these multiple phases of the cGMP product lifecycle. In her position she has provided training and guidance on a host of quality system attributes including cGMP, change control, training system, laboratory safety and infectious agents, deviations and investigations, performing audits, hosting regulatory inspections, and good documentation practices to name a few. She has assisted in multiple regulatory inspections and client driven audits. Samantha has received her Bachelor’s Degree in Biological Sciences from Colorado State University.

Danae Burseth joined RMC Pharmaceutical Solutions in March 2021 and supported a number of pharma/biotech client projects from process engineering through quality systems support. Since joining Neva Analytics in October 2022, Danae she has been involved with a variety of GMP and non-GMP (R&D) laboratory and research projects that include drug formulation development, analytical product characterization, in-use drug testing, phase 1 clinical manufacturing, cell bank generation, and laboratory method development. Danae has also been involved in projects that include performing technical reviews of laboratory documents, executing deviations/OOS/CAPA reports, and writing standard operating procedures, methods, and protocols. Danae graduated from the Colorado School of Mines in 2020 with a Bachelor of Science in Chemical Engineering and a minor in Biomedical Engineering.

Greta Stellrecht joined Neva Analytics in October 2022 and immediately began supporting routine GMP and R&D laboratory processes and procedures including, but not limited to, analytical techniques such as SDS-PAGE, UV-Vis Spectrophotometry, HPLC and capillary electrophoresis (CE). Her support of both GMP and R&D laboratory projects, includes routine stability drug testing, protein purification and cell culture. Greta supports the investigation and resolution of exceptional events (e.g., deviations/OOS/CAPAs), as well as authoring and reviewing SOPs and protocols. She is also responsible for coordinating and executing the logistics for shipping and receiving sensitive pharmaceutical samples both domestically and internationally.

Greta graduated from the University of Puget Sound in 2022 with a Bachelor of Science in Molecular and Cellular Biology.