From The Stage

Jim McNally, Ph.D.

Posted by BioAgilytix / /

Dr. McNally has an extensive background in bioanalytical assay development and program leadership spanning nearly 20 years working in the pharmaceutical and biotechnology industry. Prior to joining BioAgilytix, Dr. McNally was Executive Director at CRISPR Therapeutics, where he lead a team of scientists to develop a portfolio of assays to support development of gene-based therapeutic candidates throughout their lifecycle. He has also previously held roles at Genzyme, Pfizer, EMD Serono, and Shire which have given him broad experience in the development of large molecule, gene therapy, and cell therapy biotherapeutics.…

Steven M. Michael, Ph.D.

Posted by BioAgilytix / /

Dr. Michael is an accomplished executive with over 20 years of successful experience working in the Biotechnology and Pharmaceutical industries for companies focused on research and development. He possesses a unique skill set including people leadership, scientific expertise, and business acumen. His pharmaceutical industry experience includes drug discovery, drug development, and research technology with a focus on bioanalytical research, translational research, biomarkers, and leadership development. Before his role with BioAgilytix, Dr. Michael was an executive at Covance Inc. for 5 years where he served in a number of capacities, including…

Linda Robbie, Ph.D.

Posted by BioAgilytix / /

Dr. Linda Robbie is Vice President and General Manager, Boston Operations, and responsible for leading all bioanalytical services at BioAgilytix’s Boston, MA laboratory. She directs all initiatives as they relate to science, technology, and laboratory operations. Dr. Robbie ensures operational efficiency inclusive of effective resource management and continuous process improvement, and leads the development and validation of biomarker/bioanalytical assays across a range of technologies, including immunoassay (single and multiplex), flow cytometry, cell-based assays and targeted genomics. She has more than 25 years of experience with biomarker assay technologies, including 20…

Afshin Safavi, Ph.D.

Posted by BioAgilytix / /

Dr. Afshin Safavi is a veteran biochemist with extensive experience establishing and leading bioanalytical teams in pharmaceutical, biotechnology, and manufacturing companies, as well as contract research organizations. He and his teams have supported the development of a broad range of therapeutics in pre-clinical and clinical-trial laboratories. Prior to founding BioAgilytix in 2008, he was the Director of Ligand Binding and Immunoassay, operating under GLP at AAIPharma. At Talecris BioTherapeutics, he led the Preclinical and Clinical Assay Development team, building on his experience as a senior scientist at Nobex Corporation, GlaxoSmithKline…

Anita Simkins

Posted by BioAgilytix / /

Anita H. Simkins, ASCP, RQAP-GLP is currently the Senior Vice President of Global Quality Assurance at BioAgilytix Labs. Anita has a combination of 30 years of experience working within CLIA, ISO, GMP, GLP and GCP environments within pharmaceutical, diagnostic, biotechnology and Clinical Research Organizations. She has developed and implemented Quality Management Systems in compliance with domestic and international regulations and has had extensive Quality Assurance GxP experience in regard to the manufacturing of vaccines and bioanalytical analysis of small and large molecules. As a Quality Assurance Manager at previous companies…

Dave Williams

Posted by BioAgilytix / /

Dave has over 15 years of experience in bioanalysis and drug safety. Prior to joining the BioAgilytix team in 2017, he worked as an Associate Director of Science at PRA Health Sciences and as a Senior Scientist at Viracor-IBT Laboratories, Inc. Dave is an author of more than 25 peer-reviewed manuscripts and book chapters, and is also a committee member of the AAPS Flow Cytometry Action Planning Committee. Dave received his Bachelor’s Degree in Biochemistry from University of Kansas and his Ph.D. in Toxicology from the University of Kansas School…

Thomas Zajkowski, CPA

Posted by BioAgilytix / /

Tom has more than 25 years of experience managing finance functions in private equity-sponsored and publicly-traded companies, including multiple healthcare and life sciences organizations. Just prior to joining BioAgilytix, he served as Senior Vice President, Finance & Treasurer at Syneos Health, a CRO/CCO based in Raleigh, North Carolina. He has also held senior-level finance positions at M*Modal, a medical transcription company, and Edwards Lifesciences, a medical device manufacturer, as well as with Fortune 500 companies. He has successfully participated in and completed numerous capital raising and M&A transactions, and possesses…