Jim Hardy

Current

Owner at Gahaga Biosciences, Inc.
President & Chief Science Officer at Hemacell Perfusion, Inc.

Past

Consultant at Lonza
Director of Operations at Celsis
Director of Operations at InVitro Technologies

Manufacturing Engineering Manager at BP Solar
Engineering Project Manager at Invitrogen
Engineering Project Manager at Life Technologies, Inc.
Lab Tech IV at University of Rochester
Chemical Mixer at Kleen Brite
Telemarketing Sales Rep at Xerox

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6 more...

Education

Wittenberg University

Recommended

3 people have recommended Jim

Connections

499 connections

Industry

Biotechnology

Websites

Jim Hardy’s Summary

James Hardy is currently the CEO and a founder of Gahaga Biosciences, Inc. located in Frederick, Maryland. Gahaga Bioscience was founded in 2006 to commercialize a patented method for the isolation of stem cells from placental and umbilical tissues to be used in basic research. In essence, Gahaga Biosciences, Inc. is turning medical waste into a valuable resource with significant therapeutic potential.

Prior to his involvement in Gahaga Biosciences, Mr. Hardy accrued over 20 years of experience in the biosciences and industry, most recently as the Director of Operations with In Vitro Technologies of Catonsville, Maryland. In this position, he gained international experience by starting managing In Vitro Technologies, GmbH, a wholly owned subsidiary located in Leipzig, Germany.

Other highlights of Mr. Hardy’s career include a period as Manufacturing Engineering Manager at BP Solar in 2001 and 2002 and 13 years with Life Technologies, now know as Invitrogen. He started at Life Technologies in 1988 in the Molecular Diagnostics division where he was an integral member of the R&D staff that developed the Virapap system. This division was sold and is now well known as Digene Diagnostics (recently merged with Qiagen). Mr. Hardy progressed from the research bench into manufacturing, holding Group Leader roles in the Packaging group, Receiving, Cell Biology and Enzymes before being selected as a Sr. Engineering Project Manager where he lead improvement activities across the company.

Jim Hardy’s Specialties:

Analytical Methods / Instrumentation, Flow Cytometry, HPLC, Immunoassay development, TFF, Protein Purification and Qualification, Primary Cell isolation & culture, Stem Cells, Virus Production, Assay / Methods development, Microbiology /Fermentation, cGMP, GLP, ISO9000, ISO14000, Automated filling & packaging systems, International trade & commerce, Molecular Biology testing (PCR, cDNA synthesis, enzyme activity, gene expression), Inventory Control, MRP / ERP, Lean manufacturing.

Jim Hardy’s Experience

Owner

Gahaga Biosciences, Inc.

(Biotechnology industry)

Currently holds this position
President & Chief Science Officer

Hemacell Perfusion, Inc.

(Biotechnology industry)

February 2009 — Present (11 months)
Consultant

Lonza

(Public Company; 5001-10,000 employees; LONN; Biotechnology industry)

March 2003 — May 2008 (5 years 3 months)

Consulting on Preventive Maintenance SOPs in various areas.
Director of Operations

Celsis

(Public Company; 51-200 employees; Biotechnology industry)

July 2006 — November 2006 (5 months)

Appointed Director of Operation after Celsis acquisition of In Vitro Technologies
Director of Operations

InVitro Technologies

(Biotechnology industry)

July 2003 — July 2006 (3 years 1 month)

Strategic planning, Lean implementation, Technical development of primary hepatocyte isolation, Grew customs and Specials business to $350K annually, grew Media sales to $300K annually, Start-up distribution in Leipzig, Germany
Manufacturing Engineering Manager

BP Solar

(Public Company; 201-500 employees; Electrical/Electronic Manufacturing industry)

July 2001 — July 2002 (1 year 1 month)

Ensure efficiency and effectiveness of cell line and module assembly. Lean implementation, automation, capital equipment procurement and installation.
Engineering Project Manager

Invitrogen

(Public Company; 1001-5000 employees; IVGN; Biotechnology industry)

July 2000 — April 2001 (10 months)
Engineering Project Manager

Life Technologies, Inc.

(Public Company; 1001-5000 employees; LTEK; Biotechnology industry)

April 1988 — July 2000 (12 years 4 months)

Chronological history by position:
Sr. Project Manager, Engineering: Leading site wide process improvement projects
Group Leader, Biochemistry
Group Leader, Central Support (Fill/finish, Packaging and Warehouse operations)
Group Leader, Cell Biology
Supervisor, Enzymes
Associate Scientist III, Enzymes and QC
Associate Scientist II, Cell Biology
Associate Scientist II, Molecular Diagnostics R&D (now Digene)
Lab Tech IV

University of Rochester

(Educational Institution; 5001-10,000 employees; Research industry)

July 1985 — April 1988 (2 years 10 months)

Basic research on Protein expression, Papilloma virus gene expression, phorbol ester modulation of gene expression, steroid hormones, cell culture, 2D gel electrophoresis
Chemical Mixer

Kleen Brite

(Privately Held; 201-500 employees; Consumer Goods industry)

May 1985 — October 1985 (6 months)

Large scale chemical mixing and QC of Consumer cleaning products: laundry detergents, dish detergents etc.
Telemarketing Sales Rep

Xerox

(Public Company; 10,001 or more employees; XRX; Information Technology and Services industry)

July 1984 — June 1985 (1 year )

Telemarketing sales of Xerox memory writer type writers, photocopiers and this new fangled thing called an "Ethernet"