Scientist, Assay development, Validation, Biochemist, Microbiologist

Scott D. Askegard

New York, New York ***** Cell 517-***-**** *********@***.***

https://www.linkedin.com/in/scott-askegard-bsc-fs-bsc-psy-mba-0420115

Summary :

Scientist with Biochemical/Immunological and Microbiological experience.

Industry experience in medical devices.

Worked with all phases of protein and antibody purification.

Worked with and processed Human whole blood, plasma, bone marrow and animal blood.

Developed Elisa’s for the food and food safety industries.

Developed, tested and qualified food and feed samples by Elisa, LFD (lateral flow devices), affinity columns and other assay testing methods, for contamination by mycotoxins, allergens and food pathogens.

Experience working in a GMP-regulated environment.

Possess knowledge of routine sterile microbiological and cell culture (aseptic) techniques, basic safety procedures in BSL2 laboratory and correct storage and handling of bacteria.

Familiar with USP, GMP/GLP, ISO, FDA, EHEG and HACCP. Knowledge of USP Microbiology.

Hard working, detail focused team player. Willing to learn and take on new responsibilities.

Have Hepatitis B vaccination as I worked with Human blood at Pall Corp in the Biomed lab.

Education :

Baker College Center for Graduate Studies – MBA, Industrial Management Concentration

Michigan State University – Bachelor of Science, Forensic Science

Michigan State University – Bachelor of Science, Psychology

Summary of Qualifications :

Biochemical/Immunological, Microbiological and Product Development Experience.

Areas of Expertise:

Elisa’s – direct competitive, indirect competitive, noncompetitive direct and sandwich Elisa’s, lateral flow device technology,

Ultrafiltration, delipidation,

(Protein precipitation – ammonium sulfate, caprylic acid),

Organic extraction techniques, Solid-Liquid, Liquid-Liquid.

Polyclonal and Monoclonal antibody development and purification

Aseptic techniques and cell culture techniques

TLC, UV, EIA readers, programmable fraction collector, gamma flux irradiator, size exclusion chromatography (G-25, G-100 Sephadex), (Affinity chromatography – Protein A, Protein G, Protein A/G, DEAE anion exchange),

Diagnostic Development (ELISA’S, Lateral flow devices (LFD), Affinity columns)

Assay Development (ELISA’S. LFD’s, CFU (colony forming unit assay,)

Conformational dependent immunoform assay (CDI) optimization

Viral Plaque Assay

Media and sample buffer preparation. Filtration, sterility and growth promotion checks

Worked with balb c mice, Swiss Webster mice, nude mice, rabbits and sheep.

Liaison between R + D, QC and Manufacturing

Immuno-Assay Validation, QA/QC and R + D.

Applying Kaizen principles to daily laboratory work

Instrumental in the development validation, quality control and testing of filters for:

Viral and bacterial clearance studies of filters to be used in the Biopharma industry

Human whole blood

Leuco reduced blood

Plasma

Bone marrow

Animal blood

In Vivo Experience:

Small animal handling including dosing, blood collection and analysis

Aseptic techniques and cell culture techniques

Additional Skills:

Project Management

Microsoft Word, Excel

PowerPoint

GraphPad Prism and Minitab 16

Professional Experience :

Danaher Corporation- Global SLS Department Port Washington, NY

August 2015 to February 2016

Scientist

Viral challenging of test filters, viral clearance studies, logged reduction value (LRV) determination of all test filters, the diagnostic testing with QPCR, Plaque assay diagnostic testing, data analysis and reporting.

Used High throughput using semi-automation for the diagnostic testing as viral challenge testing of filters, this diagnostic testing tool was new technology and a joint effort between CAMS R + D and the Microbiology lab.

Acquired and implemented skills in the bacterial challenging of filters.

Worked with Medical R + D with the cell therapy lines of business.

Lead SLS scientist in charge of working with both animal and human cell therapy filtration lines.

Worked to improve and stream line all laboratory processes.

Applied Kaizen principles to daily laboratory work.

Pall Corporation - Global SLS Department Port Washington, NY April 2008 to August 2015

July 2014 - August 2015

Scientist

Worked with the viral challenges of test filters, QPCR, Plaque assay diagnostic testing, data analysis and reporting.

Acquired and implemented skills in the diagnostic testing tool the bacterial challenging of filters.

Worked with Medical R + D with the cell therapy lines of business.

Lead SLS scientist in charge of working with both animal and human cell therapy filtration lines.

Worked to improve and stream line all laboratory processes

Worked to Implement and incorporate Kaizen principles to daily laboratory processes.

Worked with the R + D CAMS group (Center for Applied Materials Science Group) developing, improving, testing, bringing and implementing new technology and new technology transfer from R + D directly to the SLS Microbiology.

Wrapped up the work with R + D CAMS group (Center for Applied Materials Science Group)

Worked with the new technology already transferred, high through put and semi-automation of testing process.

April 2012 – July 2014

Scientist (New Development and Technology Transfer)

Project management – Led projects for new development, worked directly with the R + D CAMS group (Center for Applied Materials Science Group) developing, improving, testing, bringing and implementing new technology and new technology transfer from R + D directly to the SLS Microbiology laboratory group.

High throughput and semi-automation of testing process, Viral challenges of test filters, QPCR, Plaque assay diagnostic testing, Statistical Data analysis and reporting.

Presented data at weekly new development meetings

Developed PowerPoint presentations that included statistical analysis and presentation of data.

Formal Global project submission to the Global Project database.

Formal report writing.

Developed and wrote new procedures for use by the SLS Microbiology related to the new diagnostic testing technology transferred.

Trained scientists on these new diagnostic methods and procedures.

Pall Corporation - Global SLS Department Port Washington, NY January 2008 to April 2012

Research Scientist

Worked as part of the Prion Lab, Biomedical Lab and Cell Therapy Lab Group.

Worked with Human Blood whole blood (WB), Human bone marrow, Platelets, cord blood, Packed Red Cells (PRC), and Plasma

Optimized the diagnostic testing tool the CDI for the detection of Prion in Human whole blood, Packed red cells (PRC), Plasma, lueco reduced blood and 15 % heparin solution.

Optimized the extraction procedure for the recovery of prion from Human whole blood, Packed red cells (PRC), Plasma, lueco reduced blood and 15 % heparin solution.

Developed and implemented innovative systems for filtration and or concentration of with Human Blood whole blood (WB), Human bone marrow, Platelets, cord blood, Packed Red Cells (PRC), and Plasma

Worked with both small and large scale extractions and filtrations of Human Whole Blood, Packed Red Cells and Plasma.

Worked with spiking and recovery studies with Human Whole blood. Packed Red cells and Plasma Delphia Assay optimizations and prion spiked human PRC extraction optimizations for detecting Hamster prion both pre and post filtration.

Elopak, Inc – New Hudson, MI

February 2005 to January 2008

Scientist (Microbiologist)

Performed hygienic evaluations of all gable top form, fill and seal liquid packaging machines produced at this company.

Operation of pilot plant and Aseptic filling validation

Evaluation of machinery to meet ISO class 5 air standards, in some cases ISO class 6 air standards.

Biochemical analysis and experimental testing including microbiological analysis of machine systems.

Chemical compatibility studies

Environmental monitoring, gram staining and identification of organisms and Bioburden testing

Kill rate studies with challenge organisms to determine the sterile environment within the machines and the effectiveness of machine dispensing and cleaning processes.

CIP clean-ability studies using buttermilk, orange juice, yogurt and liquid egg product and SIP sterility studies of prototype and standard dispensing machinery.

Real and viable particle counts in the environment within these machines and the environment surrounding them.

Mold testing of the machine and environment, as well as mold testing of paper-board used in conjunction with these machines.

Spore inoculation and kill rate studies with surrogate organisms

Working directly with customers and vendors.

Traveling to our paper converting plants to do plant hygiene audits. Traveling to customer sites to validate the machinery at the customer site after installation.

Neogen Corporation – Lansing, MI

June 2004 to November 2004

Lateral Flow Device (LFD) Laboratory Supervisor

Managed the LFD lab and also In charge of all transfers from R + D to the lateral flow lab of new products.

Kept track of inventory of raw materials as to safety stocks needed.

Wrote ISO documents and reviewed them for correctness before implementation.

Active member of the Safety Committee.

Supervised 6 employees in the Diagnostic Manufacturing lab that produced LFDs the diagnostic tests that detected E.Coli and Salmonella bacteria, Ruminant feed and Ruminant Bone Meal, Peanut allergen, and the deadly mycotoxin Aflatoxin B1.

Conducted ISO Awareness training of LFD lab personnel; kept ISO training records on these employees.

Flagged an order once the safety stock reached a critical limit. Organized the lateral flow lab team as to the order of the month’s production schedule.

Active member of the cost reduction team, tasked with reducing cost of the manufacturing of these key products designing flow chart’s as to process.

Neogen Corporation – Lansing, MI

June 2000 to May 2004

Senior Level Scientist (Laboratory scientist III)

Worked as a liaison between technical service, manufacturing and R + D.

Worked in the supply chain including the conjugation chemistry (Gold-Sol) behind the diagnostic tests-lateral flow devices for the detection of the bacteria Salmonella and E.coli, Quality control, R + D and manufacturing on Special projects related to manufacturing issues.

Focused on trouble shooting and problem solving in areas of lateral flow device production process improvement, process modification and design.

Trouble shooting and improving the diagnostic tests for Elisa process production.

Designed experiment tracking data, data trends and presented results at Scientific review meetings for these diagnostic tests.

Involved in media production and dispensing, formulated batch reagents needed to meet production schedules.

Followed, updated, improved standardized manufacturing forms (SPF's) and standard operating procedures (SOP's) all with the goal of implementing ISO 9000 documents and procedures in mind.

July 1992 to June 2000

Research Scientist

Developed immunodiagnostic test's (Elisa’s) both sandwich, direct and indirect Elisa’s.

Worked with Balb c mice all phases of monoclonal Ab production, polyclonal Ab with sheep and rabbits. Protein purification and conjugations. As well as cell culture.

Spiking recovery studies, cross reactivity studies, stability studies and all the validations needed to get a test from research to production as a new product for sale.

Used state of the art technology incorporating immunology, protein chemistry, affinity chromatography, protein purification, all phases of development of and production of Monoclonal antibodies and Polyclonal antibodies.

Developed ImmunoDiagnostic tests (Elisa’s) both sandwich, direct and indirect Elisa’s for food and animal safety testing involving a standard dose response curve and a statistical analysis software program to compare the product sample to the absorbance either visually with a qualitative test format or with a quantitative testing format the r squared value of the standard dose response curve within 0.989 to 1.0.

X-reactivity studies, stability studies real time, room temp and accelerated temperature studies, spiking recovery studies, correlational studies, matrix studies involving food commodities (samples) and other possible chemical, toxins and or ingredients found in food.

Involved in alpha and beta site setups and testing, and with all processes involved in getting a new test from research to manufacturing and eventually to the marketplace for sale as a new product.

Involved in problem solving within new product testing systems as well as upgrading old tests and testing formats.

Involved with the initial stages of work with chemiluminescence that eventually lead to an ATP testing system for use in production facilities to test for cleanliness of the cleaning process at these food production facilities.

Worked with mouse (murine) antibody development and production. This included working directly with Balb c mice from the initial stages to ascites production.

January 1999 to April 1999

Interim Quality Control Manager

Tested all test kits for possible defects. And

Released all test kits that passed specified test parameters.

Established and ran longitudinal retention testing for all test kits.

Trained the incoming quality systems/ quality control manager (The current Global Quality Systems Director)

Trained all QC/QS personnel. An available for any help needed to get the quality control department up and running under the new quality control/quality systems leadership.

Honors Awards and Activities :

Patent Office: World Intellectual Property Office (WIPO). Patent Collaboration Treaty (PCT) Patents.

Title: System, method and apparatus

Document No: 2009/063199

Application No: PCT/GB2008/003820

Publication No: WO/2009/063199

Application Date: 2008-11-14

Publication Date: 2009-05-22

Inventor(s)

Dean Rickey(US) ; Wineman Steven Troy(US) ; Jacques Robert Thomas(US) ; Askegard Scott Douglas(US)

A steam sterilization system for a conveyor wash using a submicron filter

Completion of Aseptic Processing and Packaging workshop at Purdue Food Science Department May 2006

Completion of the Aseptic packaging workshop in Elopak Norway May 2005

Completion of hygienic design guide training April 2005

Key Performer Award recipient in which the company Neogen Corporation expressed their sincere appreciation to Scott Askegard in grateful recognition of outstanding performance, productivity, and Dedicated Service Presented, Awarded by and signed by Jim Herbert Company President and CEO of Neogen Corporation.

Original Neogen Safety Committee member inducted 1995.

Member and Secretary of the Neogen Diagnostic Manufacturing Cost Reduction Committee.

Certificate of Appreciation present to Scott Askegard Research Scientist for the support of the ISPE NJ Student Chapter program and your contribution to the Student Tour of Pall Life Sciences February 24, 2010 presented by Joesph J. Manfredi ISPE-NJC Student Affairs- ISPE (Engineering Pharmaceutical Innovation)

Publications :

G. D. Shimer, S. D. Askegard, C. B. Bird, D. E. Dixon, R. A. Neal, B. W. Regan, D. W. Pielak, F. Lozano, L. D. Werner, E. C. Bradley, T. W. Garner, D. T. Domingo, B. M. Miller and D. J. Ledden, Neogen Corp. Lansing, MI 48912, Becton-Dickinson Microbial Systems, Sparks, Maryland 21152, Pfizer Animal Health Group, Lee’s Summit, Missouri 64081. Abstract AOAC International. Immunochemical Detection of the Anticoccidial Semduramicin.

M. M. Abouzied, S. D. Askegard, C. A. Johnson. C. B. Bird, B. M. Miller. Neogen Corporation and E. W. Sydenham, Medical Research Council: Abstract AOAC International. Analysis of Fumonisin Contaminated Corn from International Sources Using Immunoaffinity Columns.

M. M. Abouzied, S. Askegard, C. Bird, B. Miller Neogen Corp. Lansing, MI 48912. Abstract AOAC International. Fumonisin Veratox ® : A New Rapid Quantitative Elisa for the Determination of Fumonisins in Food and Feed.

M. M. Abouzied, Ph.D., S. D. Askegard, C. B. Bird, B. M. Miller. Ph.D. The Journal of Clinical Ligand Assay Vol. 18, No. 3, Fall 1995. Development of a Rapid Quantitative Elisa for the Determination of the Mycotoxin Fumonisin in Food and Feed.

M. M. Abouzied, S. D. Askegard, C. B. Bird, B. M. Miller. Neogen Corporation Lansing, MI 48912. (1996) Fumonisins in Food Chapter 12 Fumonsin Veratox ® : A New Rapid Quantitative Elisa for the Determination of Fumonisin in Food and Feed. New York: Plenum Press.

M. M. Abouzied, S. D. Askegard. D. W. Pielak, D. J. Ledden. Neogen Corporation. Abstract AOAC International. Development of a Sensitive Quantitative Immunoassay for the Mycotoxin Ochratoxin A.

M. M. Abouzied, S. D. Askegard, C. B. Bird, F. E. Klein, D. J. Ledden. Neogen Corporation. Abstract AOAC International. A Rapid 1,2,3 Quantitative Immunoassay for Aflatoxins in Grains.

M. M. Abouzied, S. D. Askegard, C. B. Bird, D. Dowding, D. J. Ledden. Neogen Corporation Lansing, MI. Abstract AOAC International. Removal of Sample Matrix Effect in Elisa Determination of Deoxynivalenol (DON) Mycotoxin in Naturally Contaminated Malted Barley.

M. M. Abouzied, S. D. Askegard, Neogen Corporation, Lansing, MI, S. L. Hefle, J. A. Nordlee, S. Taylor, University of Nebraska-Lincoln. Abstract AOAC International. Development of Immunoassay Based Tests for Food Allergens (Peanut).

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