Edward Sybert, Director, Biotechnology Industry Program

EXPERIENCE

The University of Maryland
College Park, Maryland. April 1996 - present.

Director, Technology Advancement Program, Engineering Research Center.
January 1997 - present.
Responsible for management and direction of the Technology Advancement Program (TAP), a small business incubator on the College Park Campus, with laboratory and offices for biotechnology and other tech start-up companies. Participated in design of 32,000 sq. ft. building, which features 10 biotechnology (wet) labs.

Co-director, ERC Biotechnology Program.
August 2002 – present.
Guide development of new programs in productivity enhancement and training for bioprocessing. Direct operations of the Bioprocess Scale-up Facility.

Acting Associate Director, Technology Advancement Program, Engineering Research Center.
April 1996 - January 1997.
Assist the Director of the Technology Advancement Program with overall management and direction of the program. Collaborate in development and implementation of policies and procedures.

Staff Biotechnology Consultant, Technology Extension Service, Engineering Research Center.
Provide consultation to Maryland companies in the areas of biotechnology and bioprocessing. Assist Maryland companies in forming collaborations with faculty researchers. Assist industry and faculty in developing proposals for research funding.

Consultant in cGMP Facility Design
November 1984 – present.
Provide design input to new construction or building retrofit projects involving cGMP laboratory and production facilities. Assist design team with room layouts, interior finishes, air quality, utilities, equipment specification and layout. Assist in developing validation master plan, standard operating procedures, GMP outsourcing.

PerImmune, Inc.
Rockville, Maryland.
October 1995 - April 1996.
Director, cGMP Manufacturing Facilities.
Responsible for three biopharmaceutical manufacturing facilities operating under Food & Drug Administration's current Good Manufacturing Practices (cGMP). In each facility, antibodies were produced for human diagnostic or therapeutic applications. Developed policies based on Federal regulations and guidelines. Wrote position descriptions, hired and supervised preventive maintenance and calibration staff. Planned and implemented equipment acquisitions and facilities improvements. Developed procedures for validation of manufacturing equipment and facilities.

Bio Science Contract Production Corp.
Baltimore, Maryland.
January 1994 - October 1995.
Vice President, Operations.
Responsibility for the design, specification, acquisition, installation, start-up, validation, and operation of a cGMP biopharmaceutical facility to serve the needs of companies embarking on clinical trials. The facility included two 1500 liter fermentation suites, a 150 liter fermentation suite, and a 100 liter cell culture suite. Planned operational staffing structure, wrote position descriptions and hired staff. Supervised Director of Regulatory Affairs and Quality Assurance in development of policy and procedures for regulatory compliance. Developed cost models for production scenarios. Assisted in marketing the company's resources and services to potential clients worldwide.

The University of Maryland
College Park, Maryland. 1984-1993.
Director, Bioprocess Scale-Up Facility, Chemical Engineering Department, 1985-1993.
Overall responsibility for the design, specification, acquisition, and installation of an industrial-type fermentation and cell culture pilot plant, with a mission to provide scale-up data and production support to faculty and industrial researchers. Established policies of operation for pilot plant with bioreactors from 1 to 500 liters in volume. Provided process development and small-lot production for start-up and established firms.

IGI Biotechnology, Inc.
Columbia, Maryland. 1982-1984.

Vice President, Process and Product Development, 1983-1984.
Directly responsible for development of processes leading to seven patent disclosures and two patents. Served as technology liaison to joint venture partners. Negotiated with partners and contract manufacturers to establish and meet production requirements. Interacted with marketing staff to define market niches, and developed and positioned specialty chemical products for targeted niches.

Director, Process and Product Development, 1982-1983.
Directed activities of six professional and technical staff members. Designed, specified, purchased, and installed fermentation and separations pilot plant with batch processing capacity to 250 liters. Developed and inaugurated "quality team" approach to process development for company. Achieved major capital savings by retrofitting joint venture business partner's sugar crystallization tanks for use as large-scale fermentors. Optimized processes for production of several specialty chemicals from cheese whey. Designed "cascade" process for recovery of protein from agricultural by-products, including: cheese whey, soybeans, fishmeal, and shellfish. Developed retrofit approach for use of citrus by-product as raw material for high-fructose syrup. Directed construction and operation of pilot plant for citrus project.

Manager, Fermentation and Product Recovery, 1982.
Formed new group in entrepreneurial start-up biotechnology company. Designed laboratory and installed bench-scale equipment for fermentation and product isolation and purification. Recruited and hired staff of professional and technical researchers. Interacted with company's scientific staff to develop scale-up approach for several products.

University of Maryland Hospital
Baltimore, Maryland. 1981.

Research Director, Gastroenterology Division, Department of Medicine.
Responsible for coordination of research efforts of six M.D./ Ph.D. researchers and three technicians. Developed system for tracking data and reports on all research projects involving human volunteer subjects. Participated in research projects investigating how vitamin metabolism and digestive enzyme disorders are related to disease.

NIH Chemotherapy Fermentation Program
Fort Detrick, Frederick, Maryland. 1979-1981.

Manager, Production Plant, 1980-1981.
Overall responsibility for operation of a 10,000 liter fermentation and product purification facility operating under current Good Manufacturing Practices (cGMP) guidelines. Managed staff of 13-15 professional and technical workers on a seven day per week, 24 hour per day production schedule. Produced natural-product antileukemic for human clinical trials at National Cancer Institute. Worked with heads of chemistry and microbiology sections to optimize culture characteristics, growth media, and purification protocols for maximum yield. Improved productivity of plant from 500 grams per year to 4 kilograms per year. Directed team effort to bring plant into compliance with cGMP regulations.

Recovery Foreman, Production Plant, 1979-1980.
Responsible for scheduling activities of product separation and purification wing of Production Plant. Operated and upgraded facility equipment. Developed standard operating procedures for all phases of cell separation by filtration and centrifugation, solvent extraction by mixed tanks and countercurrent extractor, concentration by wiped-film evaporators and distillation "stills", crystallization and lyophilization. Developed safety and personnel training programs to improve operator safety during large-scale solvent handling procedures.

Senior Fermentation Technologist, Production Plant, 1979.
Responsible for oversight and improvement of fermentation processes under joint development by microbiology department, research pilot plant, and production plant. Reviewed scale-up procedures. Developed standard operating procedures for large-scale fermentations in collaboration with the fermentation foreman.

W. R. Grace & Co., Washington Research Center,
Columbia, Maryland. 1967-1979.

Microbiologist, BioProducts Research Department, 1968-1979.
Responsible for all departmental bench and pilot-scale fermentations. Served as principal investigator on wide range of projects developing new products for Agricultural Products Division. Designed and initiated natural-product screening program, which resulted in over 250 "positives" over four year period. Developed and field tested two products and provided scale-up support on several others. Wrote patent applications both for novel high-moisture grain preservative and for method of its application. Optimized large-scale production and dosage delivery systems for mutated and selected mixed cultures of rumen bacteria.

Laboratory Technician, Catalyst Research Department, 1967-1968.
Assisted in the development of catalysts and catalyst supports for use in automotive exhaust systems. Carried out experiments leading to the development of low density, high pore volume extruded supports.

PROFESSIONAL ACTIVITIES

• Consultant, GMP Facility and Process Design
• Faculty, Parenteral Drug Association (PDA) Training and Research Institute.
• Mentor, University of Maryland Gemstone Program.
• Expert Witness in Microbial Production, International Trade Commission.
• Founding President, Maryland / District of Columbia Chapter, Soc. For Industrial Microbiology.
• Member, National Business Incubator Association.
• Member, Parenteral Drug Association, Maryland Chapter.
• Technical Coordinator (Biotechnology), University of Maryland, Engineering Research Center, MIPS Award Panels.

EDUCATION
BS, Biology, 1966
Loyola College, Baltimore Maryland

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