Jesse McCool, Ph.D., Senior Vice President of R&D Services
Jesse McCool, Ph.D., has over 10 years of experience in microbial process development, process characterization and technology transfer. Prior to Cytovance, Dr. McCool was the Director of Process Development at Lonza. In this role he expanded offerings in Microbial R&D Services and improved market presence through driving new technologies development, particularly in the areas of strain development, design-of-experiments (DoE), and late-stage program support. He helped to adopt a QbD framework for supporting pre-validation activities and supported numerous cGMP campaigns as a subject matter expert. He also has significant experience in six-sigma and Operational Excellence. As an established speaker, he has chaired and presented at various industry conferences including Recent Advances in Fermentation Technology, Society for Industrial Microbiology and Biotechnology, Biotechnology Industry Organization, and International Society for Pharmaceutical Engineering. He has written and contributed to numerous published papers on topics including fermentation process design and microbial expression technologies. Previous to Lonza, Dr. McCool served as Scientist at Mascoma Corporation in Lebanon, NH and Postdoctoral Research Associate at the Thayer School of Engineering at Dartmouth College, in Hanover, NH.
Valerie McDonnell, Senior Vice President of Business Development
Valerie McDonnell has more than 22 years of experience in the Biotech Industry in sales and marketing. Prior to joining Cytovance Biologics, she served as Vice President of Sales at Althea where she had the overall responsibility for all client relationship development. Prior to joining Althea, she held a Study Director position at BioReliance. She also worked at The Institute for Genomic Research (TIGR) and participated in the Haemophilus influenzae sequencing program. Valerie holds a B.S. in Microbiology from the University of Maryland and an M.S. in Biotechnology from John’s Hopkins University.
Mike O’Mara, Senior Vice President of Manufacturing Operations
Mike O’Mara has more than 23 years’ experience in biopharmaceutical contract manufacturing encompassing microbial, mammalian, and cell therapy manufacturing processes ranging from Preclinical/Phase I through Commercial. Prior to Cytovance, Mike worked at DynPort Vaccine Corporation as Senior Director of Manufacturing, and was TissueGene’s Vice President of Manufacturing, and worked for Lonza Biologics for 18 years in several operations and manufacturing positions. Mike has been part of numerous technology transfers, operational excellence initiatives, FDA and Regulatory agency audits, growing organizations, and manufacturing expansions/build-outs. Mike holds a B.S in Microbiology from The University of Maryland.
Joyce Johnson, Vice President of Human Resources
Joyce Johnson has over 18 years of experience in human resources, most recently serving as the Human Resources Executive at Cimarron Energy. Her responsibilities will be to improve all Human Resource Management practices and processes, including but not limited to Organizational Development, Talent Acquisition & Retention programs, Shared Services, full life cycle Talent Management, Employee Relations, and Compensation Analysis/Strategy. Joyce holds a Bachelors Degree in Psychology and Criminal Justice from Augusta University and an MSM in Human Resources from Troy University.
Edwin Miranda, Vice President of Quality
Edwin Miranda has over 33 years' of experience in the biopharmaceutical contract manufacturing industry, Edwin brings a depth of experience in quality assurance, encompassing solid & liquid oral dose, biologics and cosmetics. Prior to Cytovance, Edwin oversaw the Quality Assurance team in a successful FDA approval and launch of the New Drug Application (NDA) for Keppra®. He has served as Director of Quality and Vice President of Quality Assurance URL Mutual Pharmaceuticals, Inc., Legacy Pharmaceutical Packaging, and Piramal Critical Care, Inc. In these roles, he managed the quality systems, oversaw regulatory compliance functions, and developed a successful remediation plan to correct 483 observations, resulting in receipt of an Establishment Inspection Report (EIR) in good standing. Edwin, an army veteran, holds a B.S. in Biology & Chemistry from Angelo State University in San Angelo, TX.
Naomi Seresinhe, B.Sc., M.B.A., Vice President of Program Management
Naomi Seresinhe has over 15 years’ experience in program management – including four years at Cytovance, and four years’ experience in upstream Research and Development. She has experience in process improvement, as well as financial analysis for financial and manufacturing industries. Naomi currently oversees the Program Management Team at Cytovance, and holds a B.Sc. in Microbiology from University of Saskatchewan and an M.B.A. from City University in Washington State.