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Our team of process consultants and scientific directors brings decades of experience in designing and running process development programs for biotherapeutics. A member of our team can meet with you to discuss the best solution to your challenge at hand or brainstorm strategies to improve the performance of your manufacturing process.


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The Bioproduction Process Development Team provides in-the-field scientific and business support for Gibco® cell line and media products as well as Gibco® PD-Direct® Services. The unique combination of process science consultants and business development managers work globally to provide product strategies and customized solutions.

Process Science Consultation

Our process science consultants bring years of industry experience in process development to your project. Each technical consultant has previous experience in bringing a drug to market. They team with a business development manager to provide a total outsourcing solution. The technical consultant will evaluate your needs and requirements, then build a customized work plan or product-based solution to your problem. After you initiate your project, they will be with you every step of the way to insure your total satisfaction.

 Cynthia Hoy, PhD
Process Science Fellow (US West, South America, and Australia)

After a successful academic career focusing on various aspects of Chinese hamster ovary (CHO) cell metabolism including DNA repair and recombination, cell cycle control, and gene amplification, Cynthia joined the newly formed Manufacturing Sciences Department at Genentech in 1996. There, she led a team of scientists and engineers in the upstream process development and support of Genentech’s marketed products. After leaving Genentech in 2003, she held positions at the senior scientist and director level in expression technology, cell line development, and upstream process development at Fibrogen and Genitope. As a senior director at Itero Biopharmaceuticals, she recently participated in the successful licensing and technical transfer of a biosimilar recombinant therapeutic protein to Watson Pharmaceuticals, Inc. She holds both a master’s degree and PhD in Molecular Biology from University of Texas, and performed postdoctoral studies at Lawrence Livermore National Laboratories and Stanford University.

 

Robin Ng, PhD
Process Science Fellow (US East)
Soon after completing his doctoral degree, he joined at Goodwin Biotechnology, Inc. where he led the cell culture group and helped his clients to develop and deliver clinical materials. He later joined the Process Development group at Shire Human Genetic Therapies and worked on multiple projects at different stages of bio-therapeutic developments as well as supported Shire’s disposable facility start-up. He also has experience in embryonic stem cell culture as well as tissue engineering. Robin received his PhD in Chemical and Biomolecular Engineering from The Ohio State University in 2007.

 

Process Development Team

Our business development team is comprised of individuals with business experience in process development and bioproduction. Each business development manager is paired with a process science consultant to provide a team approach to the commercial management of process development.
 

Laurel Donahue-Hjelle, PhD
Leader, PD-Direct® Bioprocess Services

Laurel Donahue-Hjelle joined Life Technologies in 2006 and is responsible for the PD-Direct® Bioprocess Services business as well as strategy across the Bioproduction Platform.  Previously she was responsible for Product Development for Gibco Bioproduction.  Her team launched such products as CD FortiCHO™ cell culture medium, the EfficientFeed™ franchise and the Freedom™ CHO cell line development kits.  Prior to joining Life Technologies Laurel had both an academic career and an industrial R&D career.  She received a BA in Biochemistry from University of California at Berkeley and a Ph.D. in Molecular, Cellular and Developmental Biology from the University of Colorado at Boulder.  She was a Professor at Texas Tech University Health Sciences Center for most of the 1990s where her lab studied molecular mechanisms underlying stem cell differentiation.  In 1997 she made a career change and moved to industry where she subsequently held two R&D management positions, first with Cascade Biologics and then with Sigma-Aldrich.  In her industrial R&D career her teams developed media for primary and stem cell types and were the first to use transcriptomic approaches to develop cell culture media.

 

 Mary Melcher
Senior Business Development Manager (North America, South America, and Australia)

Mary has over 20 years of experience in the biotechnology industry, including 11 years at ZymoGenetics in a procurement role, with the subsequent years spent at Life Technologies. Mary supports the Life Technologies biotechnology process development and manufacturing community with products, services, and business solutions. Her experience has allowed her to provide innovative solutions that have accelerated the success of her customers.

 


Gibco® PD-Direct® Technical Operations Staff

Our PD-Direct® operations staff is dedicated to service project execution. Each project leader has extensive experience in successful project execution and on-time delivery.

 Stephen F. Gorfien, PhD
Sr. Director, Bioproduction R&D and PD-Direct® Services

Stephen received his PhD in Experimental Pathology from the University at Buffalo, The State University of New York., and completed postdoctoral training at the Connective Tissue Research Institute in Philadelphia, concentrating on vascular cell biology, followed by an American Heart Association Special Investigatorship in endothelial cell-matrix interactions. He joined the Cell Culture Research and Development Department of Life Technologies in 1989 as a research scientist working on serum-free medium development. As a senior scientist, his work in media development expanded to include serum-free and protein-free formulations for biotechnology applications of Chinese hamster ovary (CHO) cells, hybridomas, vascular endothelial cells, and insect cells. Stephen is also a research assistant professor in the Department of Pathology and Anatomical Sciences at the State University of New York at Buffalo, and is a member of the advisory boards for both the Department of Biotechnical and Clinical Laboratory Sciences Department at the University at Buffalo and the University of Buffalo Center for Advanced Biomedical and Bioengineering Technology.

 

Scott J. Jacobia, PhD
Senior Manager, Media Development

Scott received his PhD in Biochemistry from the University at Buffalo, The State University of New York and completed his postdoctoral training at the Institute for Human Gene Therapy at the University of Pennsylvania. Scott joined the R&D Department of Gibco in 2002. He is currently responsible for the medium development team comprised of 14 scientists. His current efforts focus on mammalian cell culture medium development and optimization, and recombinant therapeutic protein and viral expression system applications for bioindustrial customers.

 

Andrew Campbell, PhD
Senior Manager, Media Development

Andrew received his PhD in Biology from Syracuse University where he studied cellular energetics in cancer cells. He joined Life Technologies in 2007, where his current focus is on media development for commercial cell culture applications and CTS™.

 

 Jaime Goldfuss, MA
Scientist, Media Analytical Services

Jaime received his BA in Chemistry from the State University of New York at Potsdam and his MA in Organic Chemistry from the University at Buffalo, The State University of New York.. He has continued to refine his knowledge of analytical characterization of cell culture media since joining the R&D analytical team in 2002. Jaime had a brief stint within the quality analytical team, which he continues to support, before transferring to the PD-Direct® Services team. In his present role, he supports bioproduction customers and fellow R&D scientists. Currently, he is the team leader of media analytical services within PD-Direct® Services, whose sites are located in Inchinnan, Scotland, and Grand Island, New York.

 

Paula Ravnikar, PhD
Senior Manager, Cell Line Development

Paula joined the PD-Direct® Services team in 2007 after 17 years with the Schering-Plough biotechnology process development department. Paula brings experience in vector design and cloning, expression of recombinant proteins in microbial and mammalian systems, and genetic characterization of recombinant cell lines. She received her PhD in Biochemistry and Molecular Biology from Purdue University and completed a postdoctoral position with Dr. Lee McIntosh at Michigan State University.

 

Miguel Valle
Staff Scientist, Cell Line Development

Miguel received his BS degree in Chemical Engineering from MIT and, while conducting work at the NIH, his MS degree in Chemical Engineering from the University of Maryland. After two years working with Human Genome Sciences and five years working with BioReliance, Miguel joined the PD-Direct® Services team in 2007. Miguel has over 15 years of cell culture experience with a focus on production of viruses and proteins from insect and mammalian cell lines. His specialty is the development of stable cell lines for production of recombinant proteins.

 

Gregory Van Slyke
Staff Scientist, Cell Line Development

Gregory received his BS degree in Chemical Engineering from Virginia Tech University and has seven years experience in cell line development and process development for mammalian cell culture with a current focus on technology integration for cell line development including the ClonePix™ FL system. Previously, Gregory was part of the process development group at BioReliance, where he started in 2002 and focused on viral vector and vaccine process development.

 


 

 

Gibco® PD-Direct® Project Management Staff

Project management is the cornerstone to PD-Direct® Services. A project manager is assigned to each service project and provides structure, timeline management, and organized communication. Our project management team is dedicated to preserving our 95%-plus on-time performance metric.

   
     

 Michael Madigan, PMP
Senior Project Manager

Mike is responsible for custom media services in Grand Island, NY. He received his Project Management Professional certification from the Project Management Institute (PMI) in 2008, Master Certificate in Project Management from Villanova University in 2007, and his BS degree in Business Communication in 1994 from the University at Buffalo, The State University of New York.. Mike joined Life Technologies in 1987 and has worked in several roles including technical area manager for custom media development, production manager, and manager of process engineering.

 

Amy Kaczmarek, MS, MBA
Senior Project Manager

Amy has over nine years experience in management and is responsible for cell line services in Frederick, Maryland. Prior to joining Life Technologies, Amy served as program manager at Chemical Biological Medical Systems–Joint Vaccine Acquisition Program (CBMS-JVAP), where she led a multimillion dollar vaccine development program for the US Department of Defense. Amy first entered the scientific community as a quality control specialist for IMMCO Diagnostics in Buffalo, New York, before joining USAMRIID as a medical lab technician. Amy started her career in management while serving as a branch operations manager for Kinko’s, Inc. in Southern California. Amy holds an MBA and an MS degree in Biotechnology, both from Johns Hopkins University.

 

Jennifer Solazzo, MBA
Project Manager

Jennifer is a project manager for the PD-Direct® Services team in Grand Island, New York. Jennifer earned both her BS degree in Biotechnology and her MBA from the University at Buffalo, The State University of New York.. Jennifer joined Life Technologies in 2002, where she performed cell culture, media optimization, and assay development techniques using various cell lines. She then worked with the customs feasibility team on cGMP process development and batch record design.

 

Tasha Williams Wright, MS
Associate Project Manager

Tasha is currently an associate project manager for the PD-Direct® Services team in Frederick, Maryland. Tasha earned her BS degree in Chemical Engineering from Florida State University and her MS degree in Biomedical Engineering from the University of Akron. Tasha joined Life Technologies in 2007 as a R&D scientist, where she focused on mammalian cell line product development and process improvements for protein expression.

GIBCO Bioproduction New Products

GIBCO Bioproduction New Products