phone (303) 709-4316
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Our Team

Libby Russell, PhD.

Senior Vice President

Her work experiences in the biotech industry had her leading product commercialization efforts overseeing analytical, tech transfer, validation, regulatory and process development activities. She has experience working on a range of products and modalities for both drug substance and drug product GMP manufacturing including monoclonal antibodies, oligomers and glyco-proteins. She received her Ph.D. in Chemical Engineering from the University of Colorado-Boulder studying protein aggregation in cell culture. Libby continues to work with the university as a lecturer in the Chemical Engineering department.

JOANNE IZYK

Senior VP of Quality

Joanne Izyk will lead the Quality Management team at Neva Analytical, Inc. with over 23 years of pharmaceutical, horticultural and science education experience. Immediately prior to joining Neva, Joanne was the Director of Quality Assurance at Correvio LLC (a Cardiome company) where she was responsible for a variety of global Quality Management Systems (QMS) activities. These responsibilities included the management and execution of the quality and compliance audit program for affiliates, partners and contractors in over a dozen different countries on a worldwide basis. Joanne also brings to Neva hands-on experience from both commercial and development-stage pharmaceutical companies in the areas of quality control (including HPLC and various wet chemistry & physical testing techniques), analytical research and stability, technical report writing, Laboratory Information Management systems, as well as the unique compliance and regulatory expectations covered by Titles 21 of the US Code of Federal Regulations, ICH, EMA, and Health Canada. With her varied global background, Joanne will serve Neva and its clients with excellent attention to detail, comprehensive global quality, compliance and technology perspectives — and an overall commitment to execute timeline driven objectives.

Ashley Kosz

Scientist

Prior to joining Neva’s team, Ashley spent over two years in the contract research industry as an Associate Scientist. In this role, she was responsible for running a variety of analyses on large molecular weight, biologically active compounds to determine individual physical properties and quantifying related analytes within the drug substance or drug product.

These analyses were all performed while strictly adhering to cGMP protocols and included HPLC, capillary isoelectric focusing, capillary electrophoresis, gel electrophoresis, UV-spectrophotometry, and coagulation assays.

In addition, she was responsible for executing stability studies and regularly performed release activities for commercial stage drug products. She has also been thoroughly involved with method verifications, bridging studies, and analytical method transfers.

Preceding her involvement in the pharmaceutical industry, she was employed as a QA Regulatory Technician for a GMP food flavor manufacturer where she was responsible for writing technical documentation for commercial products.

Furthermore, Ashley spent two years working as an undergraduate analytical chemistry research assistant studying nutrient density profiles of Lake Michigan before graduating with a B.S. in Biology with a minor in Chemistry from University of Wisconsin-Milwaukee.

Jennifer Hanson

QM/QC Associate

Jennifer has over 12 years of experience in the GLP/GMP Laboratory, Pharmaceutical, and Education industries.  She has served as a GLP Study Director, responsible for conducting research, tabulating data, and submitting reports to the EPA for product approval before being marketed.  Jennifer also has worked in the fast paced and highly detail oriented hospital pharmacy setting, responsible for receiving, transferring, compounding, tracking, and delivering pharmaceuticals in a Level I hospital trauma center.  This work included compounding using aseptic technique in a GMP Cleanroom.  In this position she was also able to play a critical role in building and implementing a bedside scanning system to reduce medication errors, improve patient outcome, and ensure drug delivery safety.  Her exceptional work in the pharmacy led to a teaching opportunity at Front Range Community College, where she taught a full range of pharmacy technician courses in the lecture, lab, and online setting.  Jennifer received her Bachelor’s Degree in Biological Sciences with a minor in Chemistry from the University of Wisconsin-Milwaukee.

Tracey Brose

Laboratory Manager

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.

George Lewis

Senior Scientist

George Lewis has over 30 years’ experience in the pharmaceutical industry in both analytical and organic chemistry disciplines.  George has developed, verified, validated and transferred solution and solid-state analytical methods in the drug substance and product (tablets, capsules, semi-solids, extended and delayed release) realm.  He has spent time in the regulated and non-regulated environments writing regulatory and internal documents necessary to insure a smoothly functioning organization.

Saba Yohannes

QC/QM Specialist

Saba has over 16 years in development and QA/QC in the pharmaceutical industry. She received her B.S in Pharmaceutical Chemistry in the United Kingdom, then went on to work at GSK in the structural identification and pharmacokinetics department as an Associate Scientist. In this role she worked in pre-clinical research leading in vivo and in vitro ADME studies including experimental set up, dosing, sampling and hepatocyte preparation. Saba also has experience in isolation and purification of drug metabolites using HPLC, preparative HPLC and solid phase extractions.

Most recently, Saba worked for Hospira in both QA and QC roles, where she gained an in-depth knowledge of cGMP, GLP, FDA and USP principles, policies and ethical standards. Her responsibilities included conducting analysis of raw materials, in-process, API and stability sample and technical reviewing activities.

Saba has a broad range of knowledge in analytical chemistry including an array of analytical instrumentation such as HPLC, UPLC, GC, Karl Fisher, UV-VIS, FT-IR and dissolution. In her Quality Management role at Neva, she leads the technical review activities and supports GMP/QM operations.