H. Stewart Nielsen, Jr., Ph.D.
Prior to joining Nielsen, Dr. Nielsen founded AllerMed Laboratories, Inc. and served as President of the company for over 40 years. His interest in the antigenic properties of plants and microorganisms provided the foundation for developing and licensing numerous products in the field of allergy and immunology. His current interests at Nielsen BioSciences, Inc. include the diagnostic and therapeutic use of antigenic materials of Candida albicans and Coccidioides immitis. Dr. Nielsen received his B.S. in Biology and M.S. in Botany from Brigham Young University. Dr. Nielsen received his Ph.D. in Botany and Microbiology from The Ohio State University. He was awarded a National Science Postdoctoral Fellowship in Medical Mycology, which he completed at Duke University. He was a member of the Department of Microbiology and Immunology at Duke University Medical Center where he taught microbiology, mycology, and parasitology.
David P. Burney, Ph.D, MBA
Dr. Burney has had over 20 years executive experience in the pharmaceutical industry with specific experience in manufacturing, quality and regulatory functions with extensive cGMP, FDA and compliance experience in biologics and sterile products. Most recently, he served as Vice President of Quality Operations at Biotest Pharmaceutical Corp. in Boca Raton, Florida, where he managed all aspects of quality for a manufacturer of plasma derived biological sterile drugs. Prior to Biotest, Dr. Burney was Vice President and Chief Operating Officer at Greer Laboratories, Inc. where he managed the Quality, Manufacturing and Regulatory Affairs Departments for the manufacture of allergenic extracts. Dr. Burney holds a Ph.D. in Chemistry from the University of Memphis and an MBA from Ashland University.
Scott Nielsen, MBA
Mr. Nielsen has over 25 years of experience as a financial professional, with over 20 years within the biotech industry. He has executive responsibility for the general business operations of Nielsen BioSciences, Inc. including commercial operations and serves as the Designated Representative for the company with the California Board of Pharmacy. Mr. Nielsen began his career in public accounting with Deloitte in San Diego, where he was a Senior Consultant. Prior to joining NBS, Mr. Nielsen served as Vice President of AllerMed Laboratories, Inc., a biological pharmaceutical manufacturer. Mr. Nielsen is a Certified Public Accountant. He received his B.S. in Accounting from Brigham Young University and his MBA from Georgetown University.
Mr. Hattar has served as a Head of Manufacturing for Nielsen since 2022. He has over 15 years experience in the manufacturing, validation, operations and quality assurance of sterile biologics and drug products. Mr. Hattar most recently served a Global Director of Quality Assurance Validation for Abzena were he established a global validation program and provided the quality, construction and commissioning oversight of a $250mm facility in North Carolina. Prior to this tenure at Abzena, Mr. Hattar was responsible for the facility construction and commissioning of a 100,000 sq. ft. sterile drug compounding facility for SCA Pharma in Windsor Connecticut. There, he also established manufacturing processes and efficiencies, and implemented filling and inspection automation. Mr. Hattar has an AAS in Manufacturing Technology from Gateway College in Phoenix Arizona
Ms. Amaro has served as the Associate Director of Regulatory and Quality since March 2022. Prior to leading Nielsen BioScienes, Inc., Quality and Regulatory department, Ms. Amaro managed the Quality and Regulatory programs at Nielsen BioSciences, Inc., and provided oversight of CMO activities since July 2018. Ms. Amaro has over 10 years of experience in the pharmaceutical and biotech industries. She brings quality and compliance experience in GMP, GCP, and GLP. Prior to joining Nielsen BioSciences, Inc., she was responsible for oversight of the Quality programs at Bachem Americas, Inc., and Genentech, Inc. In addition to positions held in Quality, she also has experience as an analytical chemist performing extensive analytical review at H&P Mobile Geochemistry Inc. Ms. Amaro received her bachelor’s degree in Biochemistry and her minor certificate in Psychology from California State University San Marcos, where she also received an athletic scholarship.
Ms. Chavez began her career in formulation development at Drug Delivery Experts where she refined her analytical chemistry skills while developing a variety of sterile injectable protein and small molecule formulations for various pharmaceutical indications. Her formulation development included multiple aspects of optimal formulation screening including excipient selection to ensure favorable formulation characteristics, forced degradation and accelerated stability studies to identify degradants, and long-term stability studies for insight of formulation shelf life. She collaborated to develop all analytical methods used on the assortment of analytical equipment, as well as supported any method validations or method transfers required for her assigned projects. Ms. Chavez joined the Company initially to support oversight of the internal and external drug potency and stability programs. Her responsibilities have expanded to manage all aspects of the Quality Control program, which encompasses both the chemistry and microbiology laboratories. Additionally, she is responsible for all USDA and DEA related programs. She received her B.S. in Bioengineering: Bioinformatics from University of California, San Diego.
Mr. Avila Initially joined Nielsen BioSciences in 2018 as part of the research and development team, playing a pivotal role in the in-house development and manufacturing of the company’s drug substances. He collaborated closely with the R&D director to devise a range of quality control tests. These tests successfully verified critical manufacturing aspects of the drug substance cultures. In 2021, Mr. Avila took on the role of Microbiological Operations Manager, where He managed and established reliable vendor relationships for all facets of the manufacturing. He played a pivotal role in setting up vital components of the Quality Control Microbiology department, including the implementation of the environmental monitoring program. Mr. Avila’s holds a Bachelor of Science degree in Microbiology from San Diego State University and is poised to complete his Master of Science in Microbiology and Cell Science from University of Florida in mid-2024.