CAREER SUMMARY

Professional accomplishments:

Mastery of mammalian cell culture and virus propagation (Pharmacia-ENI, Hemagen Diagnostics)

Virus assays: TCID50, Plaque assay, HAI Assay, Fluorescent Focus Assay (FFA)

Managed all aspects of a culture media operation over 10 years (Clinical Sciences)

Three years’ experience in a Clinical TB laboratory (NYC Bureau of Laboratories)

Played a key role in the launch of a breakthrough immunology diagnostic product, ImmuKnow®,

Developed a series of ELISA tests in autoimmune disease that created a new line of products

Production Department leader of 25 employees (Pharmacia-ENI)

Championed several new lab product and lab service launches, validations, and scale up for the globalization of manufacturing and sales (Cylex)

Generated cost savings ($3 million) and enhanced company revenues by generating improvements in lab product and lab service quality (ENI)

EXPERTISE SUMMARY

Industrial scale mammalian cell & virus culture • ELISA • IFA • Autoimmune tests •Microbiology Formulation and use of microbiological culture media •Inverted light and fluorescent Microscopy Validations • Scale up and technical transfer to production • Safe handling of Bio-hazardous agents • working in GMP/GLP environment • Paramagnetic bead cell separation techniques • ImmuKnow® • autoclaves, dry heat sterilization and other standard lab and production equipment

PROFFESSIONAL EXPERIENCE

Scientist 2016

Paragon Bioservices

Baltimore, Maryland

Upstream virus production and purification

Quantification of virus batches through HAI, Plaque assay, Fluorescent Focus assay (FFA), TCID50,

STM protocol writing and revision.

Scientific Manager IFA 2010 to 2016

Hemagen Diagnostics, Columbia, Maryland

Responsible for all aspects of production including cell culture, virus production, liquid nitrogen cell bank and personnel training and team building

Answered customer technical questions and resolve quality issues relating to product performance.

Order supplies and research and recommend capital equipment purchases.

Continuous product improvement program

Successful redevelopment of the company’s main product, an indirect fluorescent antibody test (HEp-2/ANA) for antinuclear antibodies in autoimmune disease.

Produced detailed weekly schedules to allow maximum productivity from a small group of technicians

Team Leader

Lockheed Martin, Essex, Maryland 2009 to 2010

Certified to work in Document Preparation, which ensured safe, fast and efficient preparation of confidential forms (approximately 50 million) for high speed data capture

Received Public Trust Security clearance from Lockheed Martin

Completed training course for “Subject Matter Expert” rating to be certified to supervise all departments.

Product Development Scientist 2007 to 2009

Cylex Inc., Columbia, Maryland

Led development, clinical evaluation and manufacturing launch of FDA cleared product, ImmuKnow®

Adapted ImmuKnow®, to a new formulation of liquid stable Luminescence reagent which reduced costs and increased global sales. Validated one year 2-8C stability

Evaluated phytohemagglutinin, bacterial and viral antigen cellular immune responses in the ImmuKnow® test system.

New predictive use of ImmuKnow® technology. Independently, studied the global PHA-L response of Crohn’s and Irritable Bowel Disease in responsive and non-responsive patients to therapy at Johns Hopkins and presented data internally at Cylex

Investigated issues of lab to lab test differences and presented data and theory for well to well and lab to lab reproducibility issues.

Developed and validated a radically new blood specimen shipper that protected blood viability for 24 hours. This addressed testing labs concerns about viability of specimen after shipping.

Team player who participated in interdepartmental (CAPA) problem solving meetings. Made significant contributions to solving technical issues.

Independently, studied trending data to identify and correct troubling manufacturing results before they became an issue in the field.

Manufacturing/Development Scientist 1998 to 2007

Cylex Inc., Columbia, Maryland

Spearheaded 510K submission and launch of the first cellular immunity test kit cleared by the FDA

Optimized the blood dilution well/volume to get adequate CD4 T-cell response.

Using FACS documented the proportion of the T-cell population bound by anti-CD4 Dynabeads® in the ImmuKnow® test.

Optimized the level of PHA-L (phytohemagglutinin) stimulant using organ transplant and HIV patients.

Wrote documents to: test and approve raw materials, production SOP’s, master production records.

Evaluated raw materials from many vendors and chose primary suppliers of raw materials

Set specification for raw materials and developed testing procedures for acceptance.

Trained technicians in the proper use of biological safety cabinets and preparation of sterile reagents and their aseptic dispensing into final container.

Ensured successful transfer of product from Product Development to Manufacturing

Designed and validated all materials of the kit’s shipping box

Key player in the scale up and validation of batch volumes, reagent container selection and fill volumes

Production Manager 1994 to 1998

Dexall Biomedical Inc., Gaithersburg, Maryland

Led 6 technicians in daily operations, training and mentoring

Developed and validated ELISA assays for autoimmune diseases and Chlamydia infection for ex-US sales

IFA Production Manager 1985 to 1994

Pharmacia-ENI Diagnostics Inc., Columbia Maryland

Developed and helped validate HEp2 ANA indirect fluorescent antibody slide test

Developed and helped validate Chlamydia IgG indirect fluorescent antibody test

Developed and helped validate nDNA IgG indirect fluorescent antibody test

Managed Indirect Fluorescent Antibody (IFA) product line of 13 products. Improved chronic rejection rates from greater that 30% to less than 5%. This was accomplished by

making observations and analysis of results at the bench. This halted a chronic history of backorders and lost sales at Pharmacia

Cultivated 8 different cell lines in production.

Propagated and stored stocks of 14 different viruses in liquid nitrogen

Established and replaced the old unreliable cell stocks with new ATCC stocks.

Transformed Pharmacia’s product line to improve the quality, consistency and user friendliness

Trained technicians in aseptic technique and use and maintenance of lab equipment

Junior Microbiologist 1967 to 1970

NYC Bureaus of Laboratories, TB Lab. NYC, NY

Isolation and identification of Mycobacteria

Education: Hofstra University, Hempstead, NY – Bachelor degree, Biology

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