DME Alliance Inc | T E A M | Our Key Personnel

David M. Marks, P.E.
President & Senior Consultant

Stephen H. Kohlbrenner
Vice President, Engineering

Frank Abbato
Manager, Mid-Atlantic Operations

Andrew Borella
Manager, New England Operations

Timothy J. Hancock, Ph.D
Manager, Process Technology

Randy Nelson
Senior Project Engineer, Mechanical Design

Lynn Zeiner
Manager, Business Administration & Accounting

Resumes for staff engineers available upon request.

David M. Marks, P.E. is president and founder of DME Alliance Incorporated. He has 25+ years of experience in the specification, design and implementation of process systems. He is a frequent author, speaker and consultant on cGMP project management, equipment design & compliance topics. His professional experience is concentrated in the design and implementation of bioprocess systems for FDA-licensed commercial facilities, having served many of the leading international biotech and pharmaceutical firms since 1989. Prior to founding DME Alliance in 1998, he managed the engineering department for Associated BioEngineers and Consultants. He is active on the ASME Bioprocess Equipment (BPE) standard main committee, and serves on the polymers subcommittee and as vice-chair of the design subcommittee. A graduate of Lafayette College , Mr. Marks holds a BS in Chemical Engineering and is a registered Professional Engineer.

Stephen H. Kohlbrenner has extensive experience in facility design, process engineering and project management within FDA regulated pharmaceutical and biotechnology manufacturing facilities. He has demonstrated skills in program management, facility engineering, design of clean utilities, manufacturing support for biologics and pharmaceutical API operations, GMP equipment design, commissioning and validation. His background includes successful implementation of Conceptual Plant Design, master scheduling, P&ID Development, Process Development/ Implementation, cGMP Compliance, Retrofits of Process Equipment, VOC Abatement, Solids Handling Systems, Development of Equipment Standardization and Preventive Maintenance Programs. Prior to joining DME Alliance in 2003, he worked as a consultant and as engineering & maintenance manager for Lonza. Mr. Kohlbrenner holds a Bachelor of Science in chemical engineering from Widener University.

Frank Abbato offers a strong combination of process science experience and engineering competence. He has over a decade of experience with the biopharmaceutical industry, leveraging a background in process development to assume senior roles providing process engineering, project management, technology transfer and equipment design for multiple pilot and production scale projects (microbial fermentation, mammalian cell culture, and vaccine manufacturing). He has participated in the design and delivery of multiple process systems for pilot and large scale bioprocessing unit operations (fermentation, cell culture, MF/UF, depth filtration, centrifugation, CIP and SIP). His professional experience includes numerous assignments requiring project coordination, supplier management, process design, equipment specification, process automation development, equipment startup & commissioning and validation. A graduate of Penn State University , Mr. Abbato holds a bachelor’s degree in chemical engineering.

Andrew Borella has over 20 years of engineering experience with GMP facilities, process equipment and utility systems. He has proven technical expertise in cGMP building system design, biopharmaceutical process system design, project management, facility maintenance, construction, operations and organizational development. He is skilled in the management of cross-functional teams in the cGMP environment and has executed highly technical projects in excess of $200MM, including multiple projects for large-scale cell culture manufacturing plants, combination lab/vivarium buildings and research lab facilities. Other major projects include utility modifications, high purity water, clean steam, electrical distribution system upgrades and an automated twin turbine cogeneration plant. Mr. Borella holds a BS in mechanical engineering technology from Wentworth College of Technology.

Timothy J. Hancock, Ph.D. is an accomplished process engineer with over a decade of hands-on industry experience in GMP biopharmaceutical manufacturing operations, including lead roles with both operating and engineering companies as senior bioprocess engineer, project equipment lead, senior startup/commissioning engineer, fermentation supervisor and principal biochemical engineer. He has provided leadership in the design and implementation of pilot and large scale bioprocessing unit operations including buffer/media prep, fermentation, cell culture, MF/UF, chromatography, autoclaves, CIP and SIP. He also offers experience with bioprocess control and data acquisition (PLC/SCADA) configuration, development of User Requirements Specifications (URS) and GAMP documentation requirements for automated systems. His background includes multiple assignments in process design, equipment specification, GMP manufacturing space planning, equipment startup & commissioning and QA/validation - IQ/OQ/PQ protocol development & execution. Dr. Hancock's bioprocess experience includes microbial fermentation, mammalian cell culture, vaccine manufacturing and BL2/BL3 biohazard containment. A graduate of Lehigh University, Dr. Hancock holds an undergraduate degree in chemical engineering and Ph.D. in biochemical engineering.

Randy Nelson is a senior project engineer with expertise in the specification, design, fabrication, commissioning & qualification of custom pilot and production-scale bioprocess systems. His professional experience has focused on the process mechanical design of GMP equipment, including fermentation, cell culture, CIP skids, tangential flow filtration, biowaste inactivation and pharmaceutical packaging systems. His prior experience includes a senior positions as manager of custom engineering and manufacturing manager for a large-scale bioprocess equipment supplier (Sartorius BBI / B. Braun Biotech). Mr. Nelson’s credentials combine a B.S. in mechanical engineering, an applied science degree in automation, and over 20 years of engineering/management experience.