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.
John Conner, Vice President of Manufacturing Operations
John Conner has over 30 years of experience in research, process development and manufacturing of complex biotherapeutics. During the past 10 years at Cytovance, John has led his Manufacturing and Manufacturing Science and Technology Teams in the development and manufacturing of therapeutic proteins using Mammalian, Microbial and Transgenic processes to produce Monoclonal Antibodies (IgGs, IgMs), Therapeutic Enzymes, Fusion proteins, and Cytokines. John has also led the implementation of “Flex Suite” strategy at Cytovance for the flexible and custom development and manufacture of specialized biologic products such as Vaccines, Cellular Immunotherapeutics , Stem Cell therapeutics, Gene Therapy products, Conjugations, Tissue / Extracellular Matrix Products, Unique platforms (Insect cell lines, transgenic) and Medical Device or Combination Products.
Before joining Cytovance, John directed Manufacturing Technical Support, Manufacturing and Process /Analytical Method development at CancerVax where he characterized, developed and managed process development, scale up and manufacturing of many different complex cancer immunotherapeutics. John was also involved in the design and build out of several GMP manufacturing facilities at CancerVax. Previous to CancerVax, he held similar positions at John Wayne Cancer Institute (JWCI). Prior to JWCI, John worked at GTL-Novartis (Novartis’ West Coast Gene Therapy research and production unit). As the Process Development and Production Manager, John managed the development of viral and non-viral vectors, developed scale-up processes and manufactured retroviral vectors. John attended Texas Tech University and holds a B.S. in Microbiology and completed his M.S.Graduate Studies in Biological Sciences from the University of Texas at El Paso.
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.
Francis (Frank) Maddalo, Sr. Vice President of Manufacturing
Frank Maddalo has over 30 years’ experience manufacturing commercial cGMP products, including extensive manufacturing operations expertise extending from small molecule drugs to biologics and medical devices. Frank established and operated multiple cGMP commercial-scale manufacturing facilities in the United States, Australia, The Netherlands, Wales, and Switzerland. He produced and brought to market multiple products, including Artificial Skin, FSH, LH, HgH, , and holds several patents for commercialized collagen products. Prior to Cytovance, Frank was Vice President Operations/Manufacturing at Perosphere, Inc. where he completed the construction of a 20,000 sqft. API manufacturing facility for small molecule Drug Substance and Drug Product, including compounding, fill finish, packaging, labeling, shipping and storage. Frank commissioned and qualified the facility/utilities and validated all process operations and processes including Tech Transfer from R&D/CMO sites to in-house. His previous experience includes DSM Biologics, CR Bard, Serono Labs, and Verax Biomedical. At DSM Frank was directly responsible for the staffing and start-up of a 80,000 sq ft multiproduct biologics facility in Brisbane, AustraliaThe facility was designed to comply with all local /federal regulations (Australian) as well as the EMA and FDA. As part of the Biologics executive team Frank was responsible for the production of biologics, GMP compliance/training, QBD, operational excellence, applied process development, safety and project management. Frank holds a B.S. in Biology from the University of Massachusetts, Boston and an M.S. in Physiology/Virology from Northeastern University.
Rabi Prusti, PhD, Executive Director of Quality Control
Rabi Prusti, Ph.D., has over 20 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, and monoclonal antibody. Before Cytovance, Rabi was an Assistant Professor within the Department of Chemistry at Columbus State University. At the same time he consulted companies on matters concerning compliance, OOS investigation, Validation, Quality Control, Analytical/Bioanalytical Method Development and Optimization. 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 and abstracts. 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.