Robert Lynn Cheek

**** ***** ****** ****

Mebane, NC 27302

ac2t9f@r.postjobfree.com

336-***-****

Profile: More than 30 years of experience in immunology-related research and immunoassay development, including 10 years of experience in research and product development efforts towards production of an in-vitro diagnostics immunoassay. Experienced in Quality Systems development and maintenance to satisfy requirements of ISO audits. Skilled in personnel training and supervision.

Work History:

Advanced Animal Diagnostics

September 2011 – November 2016

Senior Scientist

Duties:

Responsible for directing the development of the reagent-related components of a diagnostic disposable device for early detection of infection in dairy cows. Product is currently on the market

Responsible for supporting the development of a lateral flow device for detection of specific bacteria infecting dairy cows

Managed a team of five scientists and four interns in all product development activities

Directed the set-up and maintenance of the R&D BSL-2 laboratory

Managed all Reagent group laboratory operations, including designing and outfitting lab space to meet the ongoing needs of all projects, maintaining lab physical plant facilities and overseeing maintenance, calibrations, and repairs on all lab instrumentation

Responsible for meeting all safety requirements involving lab facilities and instrumentation, and for safety training of all lab personnel such as lab safety and bloodborne pathogen training

Managed Quality Control testing for various components of the product lines such as disposables, readers, and kits

Oversaw the various activities associated with sample acquisition and processing, and maintenance of the in-house sample bank

Assisted in managing the in-house reagent-related manufacturing efforts for all AAD product lines, such as stained slides, blood collection devices, and lateral flow assay kits

BD Diagnostics, Women’s Health & Cancer / Tripath Oncology

October 2001–September 2011

Staff Scientist December 2007 – September 2011

Scientist III March 2006 – December 2007

Scientist II September 2004 – March 2006

Scientist I October 2001 – September 2004

Experience:

Antibody Development /Immunoassay Development

Played a major role in developing the methods used to determine clinically relevant antibody pairs from hybridomas grown to produce antibodies for numerous biomarkers

Carried several dozen ovarian cancer biomarkers through the development process from numerous antibody clones to a single pair of monoclonal antibodies chosen for clinical utility

Developed numerous ELISA assays for the various biomarkers using the chosen antibodies

Planned and performed the immunoassays, analyzed data, and presented results within lab reports. Helped keep lab compliant with Quality Systems and Safety regulations and maintained all necessary records for compliance

Participated in extensive collaborative work with the BD San Jose flow cytometer team members to align ELISA assay work on various biomarkers with cytometric bead assay work

Designed and prepared prototype RUO kits using various in-house biomarker assays for ovarian cancer

Participated in the evaluation of various liquid-handling automation systems and in the installation and validation of a Tecan Evo liquid handler. Helped design automation scripts used to aliquot serum samples and run assays for a major biomarker feasibility serum study

Served as a member of the Oncology Market Entry Instrument Assessment team. Was responsible for researching commercially available ELISA-based immunoassay platforms. Researched and presented formal reports to the team on three ELISA-based platforms

Received training on operation of the Luminex immunoassay platform, and worked closely with the Luminex platform assay development teams

Experienced in the operation of the Siemens Advia Centaur immunoassay platform

Biological Samples Bank / Serum Studies Management:

Developed and managed the system used to process, store, and retrieve patient serum samples for the ovarian cancer project serum bank.

Manager of the Specimen Procurement group responsible for the management of the in-house serum bank and the related activities of serum processing, inventory, storage and retrieval in the effort to supply serum oncology teams with serum samples for biomarker studies

Led the strategic and tactical planning and execution of numerous biomarker feasibility studies using serum cohorts ranging up to several hundred sera, with more than a dozen biomarkers being tested per study

Planned and executed a number of large scale ovarian cancer biomarker assay verification studies involving numerous biomarker assays, involving up to a thousand serum samples per study, which included liquid-handling automation and extensive data analysis

Personnel / Projects Management:

Hired two direct reports, trained and supervised several junior scientists of various levels in numerous techniques and protocols used in antibody development, ELISA immunoassay development, and ovarian cancer biomarker studies

Played a major role in the initial establishment of the Tripath Oncology Screening labs at both the initial location at BDT in RTP and at the Durham, Stirrup Creek location

Established and maintained for several months the daily Operations activities needed to support the R&D teams, and acted as liaison with both the BDT facility and the Tripath Burlington facility staffs

Acted as an advisor in efforts to develop breast cancer biomarkers; met regularly with team for data reviews

Quality Systems Management:

Head of the Quality Culture Committee responsible for developing and maintaining Quality Systems compliance at the Durham 4025 Stirrup Creek facility, resulting in two successful ISO re-certification audits of the facility

University of North Carolina - Chapel Hill, N.C.

March 1980 – April 2000

Department of Medicine, Division of Rheumatology & Immunology

Research Analyst I October 1999 – April 2000

Research Technician III May 1984 - October 1999

Department of Microbiology and Immunology

Research Technician II March 1980 - May 1984

UNC-Chapel Hill Employment Experience:

Research / Laboratory Skills

Developed and performed serological, molecular, and cellular experimental techniques used in an immunological research lab, such as: ELISA assays, RIA assays, column chromatography for antibody purification, PCR, DNA extractions, Western blots, Southern blots, tissue culture, and others. Performed data analysis and organized results for presentations

Kept labs compliant with OSHA, UNC Lab Safety Office, and UNC Radiation Safety Office regulations, and maintained all necessary records for compliance

Personnel / Projects Management

Managed an immunological research lab. Worked independently for several months, with no on-site supervision, to develop ELISA immunoassays and perform serum studies related to autoimmune disease research in order to complete a project

Instructed and supervised graduate students, medical students, undergraduates, and post-doctoral fellows in lab procedures, experiments, and lab equipment use

Chairman of Preparations Committee for Freshmen Chemistry labs during last five semesters of attendance as undergraduate at UNC in a part-time position. Responsible for the daily set-up of instructional labs for 1500 students. Supervisor of 6 to 8 students on committee; responsible for preparing work schedules and assignments and for supervising the work of the committee members.

Education:

B.S. Chemistry - University of North Carolina, Chapel Hill, N.C.

Patents:

U.S. Patent No. 7846692 B2, “HE4 Monoclonal Antibodies and Methods for Their Use”, December 7, 2010, Robert L. Cheek, Timothy J. Fischer, John W. Groelke.

U.S. Patent No. 8476033 B2, “Glycodelin Monoclonal Antibodies and Methods for Their Use in the Detection of Ovarian Cancer”, July 2, 2013, Robert L. Cheek, Eric P. Dixon, Timothy J. Fischer, John W. Groelke, Steven L. Knapp, Stephen G. Simkins, Clark M. Whitehead.

U.S. Patent No. 8252904 B2, “Glycodelin Monoclonal Antibodies and Methods for Their Use in the Detection of Ovarian Cancer”, August 28, 2012, Robert L. Cheek, Eric P. Dixon, Timothy J. Fischer, John W. Groelke, Steven L. Knapp, Stephen G. Simkins, Clark M. Whitehead.

Abstracts:

Jeffrey P. Baker, Qin He, Lorraine M. King, Robert L. Cheek, Ingrid S. Felton, Patricia Gallagher, John W. Groelke, Karen L. Lenz, Stephen G. Simkins, Steven L. Knapp, George H. Brough, Eric P. Dixon, Clark M. Whitehead. Characterization of Glycodelin Specific Monoclonal Antibodies Showing Clinical Utility in the Identification of Ovarian Cancer. American Association of Cancer Research. 2009; 1579.

Lorraine M King, Robert Cheek, Stephen G. Simkins, George H. Brough, Steven L. Knapp, Lise-Barley-Maloney, Karen L. Lenz, Jeffrey Baker, Timothy J. Fischer and Eric P. Dixon. The Molecular Characterization of two Novel Antibodies to MMP-7 and their Performance in a Serum Based Ovarian Cancer Assay. American Association of Cancer Research. 2009.

Lee-may Chen, Howard D. Homesley, Dennis R. Scribner Jr., Guilherme Cantuaria, Qin He, Robert L. Cheek, Clark M. Whitehead, Hema Doobay, Timothy J. Fischer. Performance of a Biomarker Panel to Identify Malignancy within a Pelvic Mass Population. American Society of Clinical Oncology. 2009; 5566.

Melissa D. Adams, Robert Cheek, Qin He, Patricia L. Avissar, Clark M. Whitehead,

Douglas P. Malinowski. Potential Utility of MMP-7 as a Diagnostic Biomarker in Screening for Early Stage Ovarian Cancer. American Association of Cancer Research. 2008; 966.

Dorian Henderson, Robert Cheek, Clark Whitehead, Patricia Avissar, Douglas P. Malinowski. Performance in an Ovarian-Cancer Diagnostic Assay and Epitope Mapping for anti-MUC1 Monoclonal Antibodies 16E3.3 and 8B11.2. American Association of Cancer Research. 2008; 5498.

Lorraine M. King, Marquetta Gore, Roxanne Hudson, Ramona Nelson, Melissa Adams, Bob Cheek, Clark M. Whitehead, Douglas P. Malinowski. Molecular Characterization of HE4 Message and Protein Expression in Ovarian Cancer Histological Subtypes. American Association of Cancer Research. 2008.

Braun PJ, Shivraj L, Groelke JW, Harden AT, Russell DP, Hall LB, Swan RJ Jr, Venetta TM, Baker JP, Cheek RL, Gallagher P, Felton IS, Taylor AJ, Malinowski D, Fischer TJ. A Multiplexed Microbead Immunoassay for Detection of Ovarian Cancer Markers. American Association of Clinical Chemistry, Oak Ridge Conference for Emerging Clinical Diagnostic Technologies. 2008.

Robert L. Cheek, Lorraine King, Malena M. Sansbury, Qin He, Timothy J. Fischer, Douglas Malinowski, Clark M. Whitehead. The Molecular Characterization of two Novel Antibodies to HE4 and their Utility in Detecting Early Stage Ovarian Cancer. American Association of Cancer Research. 2007; 2669.

Robert L. Cheek, John W. Groelke, Thomas M. Venetta, Qin He, Malena M. Sansbury, Timothy Fischer, Clark M. Whitehead. HE4 and Glycodelin are Serum Biomarkers for Ovarian Cancer. American Association of Cancer Research. 2006; 4504.

Publications:

Laura J. Havrilesky, Clark M. Whitehead, Jennifer M. Rubatt, Robert L. Cheek, John Groelke, Qin He, Douglas P. Malinowski, Timothy J. Fischer, Andrew Berchuck. Evaluation of Biomarker Panels for Early Stage Ovarian Cancer Detection and Monitoring for Disease Recurrence. Gynecologic Oncology; 110, (2008): 374–382.

Weintraub, J.P., V. Godfrey, P.A. Wolthusen, R.L. Cheek, R.A. Eisenberg, and P.L. Cohen. 1998. Immunological and pathological consequences of mutations in both Fas and Fas ligand. Cellular Immunology 186(1):8-17.

Kakkanaiah, V.N., E.S. Sobel, G.C. MacDonald, R.L. Cheek, P.L. Cohen, and R.A. Eisenberg. 1997. B cell genotype determines the fine specificity of autoantibody in lpr mice. Journal of Immunology 159:1027.

Creech, E.A., D. Nakul-Aquaronne, E.A. Reap, R.L. Cheek, P.A. Wolthusen, P.L. Cohen, and R.A. Eisenberg. 1996. MHC genes modify systemic autoimmune disease. Journal of Immunology 156:812.

Sobel, E.S., Kakkanaiah, V.N., Kakkanaiah, M., Cheek, R.L., Cohen, P.L., and R.A. Eisenberg. 1994. T-B collaboration for autoantibody production in lpr mice is cognate and MHC-restricted. Journal of Immunology 152(12):6011-6.

Morris, S.C., R.L. Cheek, P.L. Cohen, and R.A. Eisenberg. 1990. Autoantibodies in chronic graft-versus-host result from cognate T-B interactions. Journal of Experimental Medicine 171:503.

Morris, S.C., R.L. Cheek, P.L. Cohen, and R.A. Eisenberg. 1990. Allotype-specific immunoregulation of autoantibody production by host B cells in chronic graft-versus-host disease. Journal of Immunology 144:916.

Eisenberg, R.A., W.C. Earnshaw, B. J. Bordwell, S.Y. Craven, R. Cheek, and N.F. Rothfield. 1989. Isotype analysis of the anti-CENP-B anticentromere antibody: evidence for restricted clonality. Arthritis and Rheumatism vol. 32, No. 10:1315.

Cohen, P.L., R.L. Cheek, J.A. Hadler, W.J. Yount, and R.A. Eisenberg. 1987. The subclass distribution of human IgG rheumatoid factor. Journal of Immunology 139:1466.

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