Development Process
Resume:
John OGrady
Email: abpg77@r.postjobfree.com
Address: John
City: Phoenixville
State: PA
Zip: 19460
Country: USA
Phone: 610-***-****
Skill Level: Management
Salary Range: $105,000
Willing to Relocate
Primary Skills/Experience:
See Resume
Educational Background:
See Resume
Job History / Details:
JOHN H. O'GRADY
3206 Pine Glen Ct.
Phoenixville, PA 19460
abpg77@r.postjobfree.com
EXPERIENCE
Experienced with all aspects of purification process development
Design and outfitting of purification laboratories and pilot plant facilities
Design and development of processes for purification of a variey of recombinant molecules including monoclonal antibodies, fusion proteins, live virus, virus like particles (VPLs) and others
Experience with purification from mammalian, yeast, E. coli, and insect cell lines
Extensive knowledge of cGMP procedures and requirements
Written SOPs, batch records, and process development reports for all aspects of development and production
Production of supplies for toxicology/animal studies through Phase 3 clinical manufacturing
Experience with the design and execution of viral clearance validation studies
Experience with all types of chromatography media and filtration systems
Experience with coordinating and supervising contract manufacturers
Experience with technology transfer to internal and external groups
WORK HISTORY
PHASEBIO Pharmaceuticals Malvern, PA 12/07 6/12
Director, Process Purification
Responsible for all aspects of purification process development. Established the purification laboratory and hired personnel. Designed and developed the processes for purification of E. coli derived fusion proteins for cGMP manufacuring. Also responsible for scale-up and technology transfer of the processes to contract manufactures. Acted as the primary contact for contract manufacturers and as the person in the plant during manufacturing campaigns.
BIOREXIS Pharmaceuticals King of Prussia, PA 12/03 12/07
Director, Process Purification
Responsible for all aspects of purification process development. Established the purification laboratory, hired personnel, designed and outfitted the lab and pilot plant facilities. Designed and developed the processes for purification of yeast derived fusion proteins for cGMP manufacuring. Also responsible for scale-up and supervision of pilot plant operations for production in support of clinical trials. BioRexis was acquired by Pfizer in February 2007 and the BioRexis King of Prussia facility was closed in December of 2007.
TITAN Pharmaceuticals South San Francisco, CA 8/02 5/03
Manager, Process Development.
Provided experimental direction to outside contract development laboratories and contract manufacturers, monitoring their progress, and evaluating results. Additional responsibilities included writing and reviewing SOPs and Batch Records, reviewing completed manufacturing records, assisting in assay development, troubleshooting, technical transfer, and writing progress reports and data summaries. My time at Titan was unfortunately brief due to unfavorable late stage clinical trial results.
ONYX Pharmaceuticals Richmond, CA 6/99 8/02
Scientist; Process Sciences
Supervisor of purification process development with the focus on development and scale-up of procedures for purification of recombinant live viruses. Additional responsibilities included supervising junior staff in carrying out experimental plans, writing process development reports and presentation of data to internal and external audiences. Responsible for technology transfer to contract manufacturing sites and monitoring of CMO operations. This involved extensive interaction with regulatory, clinical, QA/QC, and multiple outside contractors. Responsibilities also included design and execution of validation studies, lot release data review, and writing manufacturing batch records.
MEDIMMUNE Gaithersburg, MD 4/93 - 6/99
Scientist; Process Biochemistry
Supervision of purification process development and scale-up involving monoclonal antibodies and VLP based vaccines. Lead scientist in the development of the Synagis
monoclonal antibody purification process. Focus on purification of proteins from mammalian, and insect cell lines. Experienced with pilot plant operations and cGMP process and validation procedures. Supervised junior staff in planning and execution of process development experiments, and pilot plant operations.
MICROGENESYS Meriden, CT 6/92 4/93
Senior Scientist; Purification Development
Responsible for purification process development and scale up of a recombinant VLP based vaccine produced in insect cells. Supervised production and development personnel in execution of procedures and methods development. My time at MicroGenesys was short due to withdrawl of funding by the corporate partner.
CENTOCOR Malvern, PA 11/91 - 6/92
Senior Research Associate; BioPharmaceutical Research and Development
Responsible for purification process development involving recombinant monoclonal antibodies. Responsibilities also included supervising and directing other laboratory personnel in execution of experiments. My time at Centocor was unfortunately short due to unfavorable late stage clinical trial results.
SMITHKLINE BEECHAM King of Prussia, PA 11/89 - 11/91
Scientist; Biological Process Sciences
Responsible for purification process development and scale-up involving recombinant therapeutic proteins, including independent development and execution of protocols and procedures for the manufacture of therapeutic proteins in a cGMP environment. Responsibilities also included development and optimization of immunoassay systems for monitoring process performance.
Department liaison to the Computer and Information Sciences Division. Coordinated computer requirements and resources. Acted as technical consultant for computer issues within the division including trouble shooting and training (PC and Mac). Responsible for setting up and maintaining the LAN within the building. Experienced with a variety of data acquisition and control systems.
EASTMAN KODAK Rochester, NY 4/81 - 10/89
BioProducts Division 4/86 - 11/89
Experience in large scale production and purification of biochemicals and monoclonal antibodies. Responsibilities included process development and media optimization using DOE statistical approaches for microbial and mammalian systems, development and optimization of immunoassay systems, operation of large and small scale fermentation and purification equipment. Extensive training in biochemical engineering priciples.
Clinical Products Division Instrumentation Group 9/84 - 4/86
Performed instrument and software testing in support of the EKTACHEM clinical diagnostic analyzer. Extensive data analysis responsibilities, requiring use of statistical methods and programs.
Clinical Products Division Evaluation Group 4/81 - 9/84
Performed reagent development and release and testing in support of EKTACHEM analyzers. Gained experience in statistical analysis and experimental design.
EDUCATION
University of Rochester Rochester, N.Y.
School of Medicine and Dentistry
M.S. Biochemistry 12/89
Michigan State University East Lansing, MI.
School of Natural Science
B.S. Microbiology 9/79
PUBLICATIONS / PRESENTATIONS
OGrady, J.H., Losikoff, A., Poiley, J., Fickett, D., Oliver, C.,
Viral Removal Studies Using Nanofiltration Membranes
Viral Safety and Evaluation of Viral Clearance from Biopharmceutical Products. Editors Brown, F., Lubiniecki, A.S., Dev. Bio. Stand.
Vol. 88, pp 319-326 Krager Press 1996
Wasserman, G.F., Priest, M., Wood, D., O'Grady, J.H., Tsao, E., Mason, M., Devaney, M., 1993
Preparation of a Human Parvovirus Vaccine from a Recombinant Baculovirus/Insect Cell Expression System
Presented at the AICHe meeting St. Louis, 11/93
Johnson, S., Bansal, G., Couchenour,D., Dillon, S., Dormitzer, M., Feller, D., Goldman, D. O'Grady, J.H., Pfarr, D., Riggin, C., Tamura, J., 1993
Humanized Antibodies to Respiratory Syncytial Virus; Production and Preclinical Evaluation
J. Cell. BioChem. 23rd Keystone Symposia 18D:T105
OGrady, J. H., Wasserman, G. F. 1991
An Analytical Immunoaffinity Chromatographic Method for a Soluble Recombinant Form of Human Complement Receptor-1.
Presented at the Affinity Purification of BioPharmaceuticals Conference
Philadelphia, PA June 1991.
Scalice, E.R., Hinchman, C.R., OGrady, J.H., Hosimer, P.C.,
Dais, J.L. 1991.
Interactions among Anti-Creatine Kinase Monoclonal Antibodies and CK Isoforms: Differential Inhibition and anti-Inhibition.
Presented at the 43rd National Meeting of the American Association of Clinical Chemistry, Washington, D.C. July 1991
O'Grady, J. H., Looney, R. J., Anderson, C. L. 1986.
The Valence for Ligand of the Human Mononuclear Phagocyte
72kD High-Affinity IgG Fc Receptor is One.
J. Immunology 137:2307
PATENTS
1993 G. Folena-Wasserman, J. O'Grady, T. Smith, J. Lifter. Combination chromatographic purification of soluble complement receptor type 1.
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