cGMP Manufacturing at Cytovance Biologics, Oklahoma City, OK


Darren Head, President and Chief Executive Officer

Darren Head has 22 successful years of experience in biological, device and drug manufacturing operations.  For the last four 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 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 is a Desert Storm vet.  He holds a BS in Biology and attended the executive a MBA program at Texas A&M.

Richard Vaillant, Senior Vice President and Chief Financial Officer

Richard Vaillant has more than 26 years of financial operations and management experience in the life sciences industry.  Previous to Cytovance, Richard served as Chief Financial Officer, Treasurer and Secretary of Histogenics Corporation, where he was responsible for all financial operations, Information systems and Human resources.   Prior to Histogenics, he was the Corporate Operations Controller with American Cystoscope Makers, Inc. Prior to American Cystoscope, he was the Division Controller at Boston Scientific for 12 years.  Richard earned a B.S. in Business Administration from Merrimack College and a M.S.A. from Suffolk University.

Donald Wuchterl, Senior Vice President of Manufacturing Operations

Donald Wuchterl has over 22 years of experience of clinical and commercial GMP manufacturing in biologics, small molecules, and peptides. He has extensive experience in the design, validation, start-up, licensure, and operation of biologics facilities. Prior to joining Cytovance, Don was Director and Head of Manufacturing at the Dendreon Immunotherapy Manufacturing facility in Union City, Ga. In this capacity, he was integral in the construction, startup, licensure, and subsequent launch of “Provenge,” the first immunotherapy approved by the FDA, from this facility. Before his work with Dendreon, he held the position of Director of Manufacturing at Shire, Human Genetic Therapies. This included General Manager responsibilities for the end user design and start-up of Shire’s, Lexington Massachusetts Mammalian Cell Culture facility (Building 400), expanding their enzyme replacement therapy manufacturing capacity. Previous to Shire, Don held several manufacturing management positions of increasing responsibility with Amgen. This included assignments at Amgen manufacturing facilities in Colorado, Rhode Island, and Cork Ireland. He also held positions of increasing responsibility with Biogen Idec and Roche. Don received his Bachelors of Science degree from Colorado Technical University and has completed the majority of coursework on a Master’s degree in Administrative Leadership from the University of Oklahoma.

John Conner, Vice President of Manufacturing Science and Technology

John Conner has over 30 years of experience in research, process development and manufacturing of complex biotherapeutics.  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. 

Mark Adams, Vice President of Program Management

Mark Adams has more than 20 years experience in the biotech industry in Program Management, Alliance Management, Product Management and Commercial Business Development in both proprietary and client-centric business environments with industry leaders and innovators.  Prior to Cytovance, Mark held positions of increasing responsibility in technical and commercial management at Pharmacia Biotechnology AB, PerSeptive Biosystems, Lonza Biologics and Genzyme Transgenics. Most recently, he was Program Executive at Shire Human Genetic Therapies in Cambridge, MA with responsibility for pipeline product development programs. Mark earned a B.S. and M.S. in Biochemistry from University College in Cork, Ireland.

Valerie McDonnell, Vice President of Sales and 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.  

Scientific Leadership

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. 

John Lightholder, Vice President of Downstream Process Development

John Lightholder has over 35 years of experience in process development and production of biotherapeutics. Before joining Cytovance, John most recently served as Director of Process Development at Genzyme, where he managed and developed purification procedures for multi-subunit recombinant enzymes and monoclonal antibodies. Previously, he held the same position at Collagenesis, designing and enhancing production methods for dermal matrix products. Prior to Collagenesis, John was Director of Purification Development at Creative BioMolecules, culminating twelve years managing nearly every aspect of development and production of multiple therapeutic products. Previously he spent 15 years as a research associate and scientist at Damon Biotech, Tufts-New England Medical Center, The Salk Institute, Stanford University Medical Center, New England Deaconess Hospital, and the University of Massachusetts. He holds B.S. and M.S. degrees in Microbiology from the University of Massachusetts.

Jonathan Mitschelen, PhD, Vice President of Upstream Process Development

Jonathan Mitschelen, Ph.D., has over 30 years of experience in research, process development and manufacture of complex biotherapeutics.  Prior to Cytovance, Jon was a Process Development Senior Scientist at Regeneron Pharmaceuticals where he established the company’s mammalian cell pilot plant production facility and developed bioreactor production processes.  As Senior Director of the Regeneron pilot plant, he developed a 25-member team for GMP manufacturing operations, analytical support, and facilities management.  He managed this team to produce the clinical supplies for successful IND submissions for Regeneron’s first therapeutic fusion proteins produced in mammalian cells.  Before Regeneron, Jon was employed by Rhone-Poulenc Rorer and Meloy Labs, where he provided services for cell culture and microbial bioproduction and protein purification to support therapeutic product development and for contract support services to NIH.  Jon completed his Bachelor of Arts degree in Biology at Anderson University.  He holds a Ph.D. in Biochemistry from Purdue University, and completed his post-doctoral studies at Wake Forest School of Medicine. 

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.