Darren Head, President and Chief Executive Officer
Darren Head has 26+ successful years of experience in biological, device and drug manufacturing operations. For the last seven years, Darren has built Cytovance Biologics to one of the most premier Contract Manufacturing Organizations in the Biotech industry. Prior to joining Cytovance he served with Immucor Inc., as Senior Vice President of Worldwide Operations. He directed commercial activities for all global operations around the globe He was also directly involved in numerous commercial product launches. Prior to joining Immucor, Darren headed Aronex Pharmaceuticals manufacturing and clinical supply operations in late Phase 3 programs. He was instrumental in preparing CMC sections for two NDA submissions and was involved in selling both drug platforms to corporate partners. Darren also served the first 14 years of his career as the Senior Director of Operations for Allergan Inc. and Manager of Operations at Abbott Laboratories. In addition, he proudly served in the United States Air Force as a Desert Storm vet. He holds a BS in Biology and attended the executive MBA program at Texas A&M.
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.
Maria Lopez, Vice President of Quality Systems
Maria Lopez has more than 15 years experience in the Pharmaceutical/Biotech industry. Prior to joining Cytovance, Maria was Site Quality Head at ALCON, a division of Novartis where she was responsible for all Quality functions at the John’s Creek contact lens manufacturing facility and for the continuous improvement of the site Quality System. Prior to that, she held the Director of Quality/Manager of Quality Assurance position with Immucor, Inc. where she led the implementation of a Quality System to ensure compliance with domestic and international regulatory agencies and lead the site in remediation of compliance related issues. Before her work with Immucor, Maria served as a Scientist II for Valentis, Inc. where she developed new assays to test protein expression from plasmid-based medicines and performed quality assurance batch record reviews. Maria holds a Bachelor of Science in Biology and Chemistry from Texas A&I University in Kingsville.
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.
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.
Rabi Prusti, PhD, Executive Director of Quality Control
Rabi Prusti, PhD, has over 25 years of experience in R & D, Quality Systems, Quality Control and Compliance, Assay Development, Validation, CMC Documentation including IND, NDA & DMF. As a biochemist he has product development experience in new product and commercial platforms with human growth factors, virus free plasma proteins, bacterial proteins (enzymes), cell based immunotherapy product, monoclonal antibody, fusion proteins, and cytokines. Before Cytovance, Rabi was an Assistant Professor within the Department of Chemistry at Columbus State University. At the same time he consulted biotechnology/biopharmaceutical companies on matters concerning compliance, Quality Control, CMC, Stability Study Program, OOS investigation,Validation, Analytical/Bioanalytical Method Development, Optimization, and Method Validation. Prior to Columbus State University, he held senior positions at CancerVax, Protein Helix, BioSpecifics Technologies, V. I. Technologies (VITEX), and Curative Technologies/ Health Services (CURE). He has written and contributed to numerous published papers, book chapters and conference presentations. Rabi completed his Bachelor of Science at Utkal University in India, Master of Science and Master of Philosophy at Nehru University, New Delhi, India. He holds a Ph.D. in Biochemistry from Texas Tech University and completed his post-doctoral research at the University of Washington, School of Medicine in Seattle.
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.