Quality Assurance Control

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

Madison, WI *****

Home: 608-***-****

******.***@*****.***

Julie A. Johnson

• Over 25 years of clinical cytogenetic experience; Over ten years of experience in stem cell cytogenetics

including test result review and interpretation

• Strong background in cytogenetic laboratory management.

• Strategic direction of services and products, and personnel management.

• Strong operations, laboratory planning, and project management background including budget preparation

and cost accounting.

• Extensive regulatory (CAP, GLP, OSHA) and quality control/quality assurance experience

• Ability to effectively communicate scientific and technical information. Strong teamwork skills and the

ability to motivate team members.

EDUCATION

• The George Washington University, Master of Science Degree in Cytogenetics, 1980

• University of Wisconsin, Bachelor of Science Degree in Biology, 1976

CERTIFICATIONS

• CG(ASCP)CM, American Society of Clinical Pathologists certification in cytogenetics, 2010-Present.

• CLSP(CG), NCA Certified Specialist in Clinical Cytogenetics 1980 – 2010

AWARDS

• Tissue Culture Association National Scholar, 1979, 1980

• March of Dimes Young Investigator Grant, 1992

APPOINTMENTS

• Board Director, Cell Line Genetics, 2005-Present

• Technical Board Member, Stem Cell Training Program, Madison University, 2012-Present

• University of Chicago Hospitals QA/QC Compliance Task Force, 1990-1991.

• CAP Cytogenetics Laboratory Audit Team, 1988, 1989, 1999

• NCA Cytogenetic Certification Review Board, 1987-1990

AFFILIATIONS

• International Society of Stem Cell Research (ISSCR), 2005-Present

• Association of Genetic Technologists (AGT), Founding Member, 1978

PROFESSIONAL EXPERIENCE

Cell Line Genetics, Inc., Madison, Wisconsin, 2005-Present

Director of Laboratory Operations

• Launched a privately funded startup company, Cell Line Genetics, Inc., to provide cytogenetic services and cell

line identity testing to the stem cell research community providing rapid turnaround time and clinical grade

services. Tests include karyotyping, DNA fingerprinting, mycoplasma testing, FISH, transgene insertion point

identification. Responsible for implementing and validating all tests and procedures

• Provided services for over 400 major players from academia, private industry, cell banks, and large

pharmaceutical companies in the U.S and Europe. Recognized as the “go to” place for stem cell karyotyping.

• Responsible for laboratory set-up transforming a vacant space into a fully operational laboratory with certified

cytogenetic technologists, Standard Operating Procedures, and validated tests.

• Responsible for strategic direction of services, products and personnel management.

• Set up the lab in compliance with CAP, GLP, and OSHA regulatory guidelines and successfully passed client

audits.

• Reviewed over 17,000 karyotypes and DNA fingerprints from embryonic and reprogrammed stem cell lines

consistently meeting 5-10 day turnaround times and providing excellent customer service.

• Managed 10 technologists and performed annual performance reviews for raises and bonus distributions.

• Prepared capital and operating budgets including cost accounting of new and expanded services.

• Implemented quality control quality assurance monitoring system to detect negative and positive trends

• Wrote Standard Operating and Policy manuals.

• Performed workload recording and generated employee productivity statistics to justify hiring new employees.

• Reviewed test results and discussed interpretations with clients.

• Directed large scale manufacture of DNA probe production, generating over 100 custom built probes as an

alternative to purchasing commercial probes reducing reagent cost from $25-$50 to less than 10 cents per

hybridization reaction.

• Led a large scale array CGH validation project involving culturing over 80 cell lines and custom manufacture of

over 100 DNA probes including correlating FISH results with expected chromosome abnormalities.

• Directed a large scale transgene insertion point mapping project using custom probes on cultured lymphocytes

from transgenic rat breeding colonies.

• Performed proof of concept studies and led the development of two products based on patent pending

technology. Summer 2013 product launch date.

• Collaborated with the Business Development Director and Chief Scientific Officer on advertising and

marketing materials.

Wisconsin State Laboratory of Hygiene, Madison, Wisconsin, 2000-2005

Advanced Molecular Cytogenetic Technologist

• Supervised three cytogenetic technologists in a full service FISH laboratory. Responsible for coordinating and

organizing the daily work routine including case prioritization and work flow, overseeing test performance,

reviewing test results and assigning interpretation codes. Processed a wide variety of FISH specimen types

including cytogenetic specimens, paraffin embedded tissues, touch preps, buccal smears, cytospins, and

pleural effusions. Performed tests using a full library of probes and probe strategies. Obtained certification in

Aneuvysion and Her-2 neu. Worked closely with a pathologist on Her-2 neu testing. Administered CAP

proficiency testing in the FISH section and was a CAP inspector.

• Validated probes, determined cut-off values and evaluated probe performance.

• Correlated test orders with referring diagnosis to determine a.

• Managed the lab in compliance with CAP, JCAH, and OSHA; and prepared the lab for inspections.

• Wrote the FISH procedure and Policies manuals.

• Performed cost accounting to justify initiation of new procedures and assays.

• Co-ordinated a multi-species cell line karyotyping program. Implemented an STR based cell line identity test

(PowerPlex 16) for theWiCell National Stem Cell Bank.

• Prepared a feasibility study to purchase an automated FISH processing unit (VP-200). Proposal was approved

and the unit was purchased, reducing tech hands on time.

• Ordered supplies and signed purchase orders.

• Stepped up to the plate and single handedly accepted the challenge to keep the FISH lab operational when it

was in danger of discontinuing services.

Wisconsin State Laboratory of Hygiene, Madison, Wisconsin, 1997-2000

Senior Cytogenetic Technologist

• Performed routine cytogenetic culturing and harvesting procedures on amniotic fluid, CVS, blood, tumors, and

stem cell lines. Analyzed preparations using G-banding and specialty stains. Reviewed case results performed

by lab technologist with the director. Communicated results to physicians and genetic counselors.

• Participated in and administered CAP proficiency testing.

• Trained co-workers to accurately identify and separate maternal vs. fetal tissue from spontaneous abortions

reducing culture failure and bring the abnormality rate and sex ratio in line with published data.

• Implemented Ethidium Bromide protocol to increase resolution of POC and bone marrow preps.

• Researched and submitted a proposal for purchasing automated karyotyping systems (Applied Imaging).

Proposal was accepted and four units were purchased.

• Co-authored a cytogenetics teaching website for high school teachers with the University of

Wisconsin–Baraboo, Department of Zoology.

• Initiated setting standards for acceptable band resolution.

St. John’s Mercy Medical Center, St. Louis, Missouri, 1993-1997

Advanced Cytogenetic Technologist

• Performed prenatal and postnatal cytogenetic testing at the largest birthing hospital in the US using routine G-

banding and specialty stains. Performed CAP proficiency testing.

• Identified Quality Indicators and was a member of the General Laboratory QAQC Committee.

• Characterized multi-species cell lines from mouse, rat, and pig.

• Modified and re-structured work flow increasing specimen handling efficiency.

• Developed a feasibility study and budget proposal to utilize FISH technology as an adjunct test to cytogenetics.

• Implemented in situ coverslip harvesting of amniotic fluid samples.

The Genetic Network, Palos Heights, Illinois, 1992-1993

Cytogenetics Supervisor

• Supervised ten technologists and coordinated the daily activities of a high volume for-profit commercial

laboratory. Conducted annual performance reviews. Interviewed candidates for hire and trained new employees.

Prioritized cases and directed work flow. Established work schedules. Reviewed technologists case work and

recommend appropriate follow up testing. Oversaw CAP proficiency testing and maintained compliance with

CAP, OSHA, and the Illinois Department of Public Health regulatory requirements. Prepared monthly QA/QC

reports. Discussed test results with the Medical Director.

• Monitored spending and prepared budgets.

• Implemented new culture procedures and modified existing techniques improving specimen quality and

improving turnaround time

University of Chicago Prenatal Cytogenetics Laboratory, Chicago, Illinois, 1988-1992

Cytogenetics Supervisor

• Supervised five technologists. Performed cytogenetic analysis on amniotic fluid, CVS, peripheral blood, and

POC specimens. Wrote reports and consulted with the Medical Director on complex cases. Performed work

load recording to assess productivity and to justify new hired. Performed merit reviews and recommended

raises. Prepared capital budgets and ordered equipment and supplies.

• As special project assistant to the Director of Laboratory Medicine I worked with a task force of technologists

from various departments to strengthen regulatory compliance in twenty six laboratories. The QA/QC

Compliance Task Force performed mock CAP inspections and developed a harmonized Quality Improvement

Plan for all laboratories.

The Alexandria Hospital, Alexandria, Virginia 1981-1988

Cytogenetics Supervisor

• Supervised four technologists and oversaw daily laboratory operation of the cytogenetics laboratory in a private

hospital setting. Performed routine cytogenetics testing including tissue culture and routine/specialty stains.

Modified techniques to ensure optimal specimen preparation. Performed chromosome analysis from karyotypes

and at the microscope.

• Assess technologist job performance and conducted annual reviews. Performed workload recording and

employee productivity statistics to justify new hires. Prepared operating and capital expense budgets and test

cost analysis. Oversaw QA/QC program. Prepared for CAP inspections and maintained compliance with CAP

and JCAH regulatory agencies.

Bureau of Biologics, FDA, 1980-1981

• Performed cytogenetic testing in a research environment.

• Performed cytogenetic characterization of normal and abnormal cell lines derived from different species using

routine and special stains. Worked to correlate CEA (carcinogenic antigen) expression with karyotype

evolution in tumor cell lines.

• Performed mutagenicity testing on cell cultures exposed to toxic chemicals and carcinogens using sister

chromatid exchange and chromosome breakage analysis.

INVITED PRESENTATIONS

• Cytogenetic QA/QC Issues and hES Cell Culture. Human Embryonic Stem Cell Toolbox Training Program and

Symposium, University of Georgia, 2003 – 2006.

• Resident Training Program, Dept. Pediatrics and Department of Pathology, UW Medical School, 1997– 2005.

• Molecular Cytogenetics for Cytotechnologists. Cytology Training Program, WSLH, Madison, WI, 2003-2005.

• Fluorescence in situ Hybridization: New technologies in Molecular Pathology. School of Cytology, WSLH,

Madison, WI. 2001-2002.

• Human Embryonic Stem Cell Culture Cytogenetic Quality Control, WiCell Research Institute, 2003.

• FISH Technology: New Applications in Cytology and Pathology. Presented in the School of Cytology, Barnes

Hospital, St. Louis Missouri, 1996.

• Tumor Cytogenetics: An Overview. Presented in the School of Cytology, Barnes Hospital, St. Louis Missouri,

1995.

• Introduction to Cytogenetics. Presented in the Department of Pediatrics Resident Training Program, Christ

Medical Center, Chicago, IL, 1992-1993.

• Resident Training Program, Department of Maternal Fetal Medicine, University of Chicago Pritzker School of

Medicine, 1989-1991.

ABSTRACTS AND POSTERS

Johnson JA, and Israel J. Prenatal diagnosis of inv(X)p22.3-q26) in a fetus: A counseling dilemma. 24th Annual March

of Dimes Clinical Genetics Conference, Palo Alto, CA. 1992.

Johnson JA and Israel J. Familial paracentric inversion involving the short arm of chromosome 7. 24th Annual March

of Dimes Clinical Genetics Conference, Palo Alto, CA. 1992.

Johnson, JA, and Israel, J. Familial complex chromosome rearrangement involving chromosomes 2, 3, and 22

resulting in a child with partial trisomy of band 2q33-2q37. American Society of Human Genetics, Washington, DC.

1992.

Olszewski J, Johnson J, Panella J, Davis T, Oxendine K, Kozitske E, Love C, Bourdeau-Heller J, and Meisner L.

Processing for Success: POC Cultures Are Not Affected by Delayed Transit. 24th Annual Meeting of the Association of

Genetic Technologists, Orlando, Florida, June 17-20, 1999

Siddiqui J, Meisner LF, Johnson JA, and Wood G. Expression of DDR2 and metalloproteinases in human

melanocytes and melanoma cell lines. Investigative Dermatology (Joint Meeting of the European Society for

Dermatological Research, Japanese Society for Investigative dermatology and Society for Investigative Dermatology.

Miami Beach, Florida, April 30-May 4, 2003.

Martin LS, Johnson JA, Wells WE, and Meisner LF. Autism and novel duplication in 15q11-13 GABRB3 region.

American College of Medical Genetics Clinical Genetics Meeting, Kissimmee, Florida, March 4-7. 2004.

Panella J, Williams M, Miller C, Johnson J, Wells W, Qi Z, Meisner L, and Yu J. Use of telomere and specific locus

FISH probes to detect deletions within duplications. American Society of Human Genetics 2003 Conference, Los

Angeles, California, November 4-8, 2003.

Meisner LF, Finger JM, Salguero ML, Johnson, JA. Karyotype instability and cell line authentication in embryonic

stem cell cultures. 6th Annual Meeting for the International Society for Stem Cell Research, Philadelphia, PA, June 10-

14, 2008

Meisner LF, and Johnson JA. Comparison of Chromosome Aberrations between Human and Mouse ESC vs. iPSC.

SBS Stem Cell Symposium: “Screening Stem Cells: From Reprogramming to Regenerative Medicine” Boston,

MA, September 2-3, 2009,

Johnson JA., Panella J, Zeier R, Wells W, Finger J, Meisner LF. Etiology of Chromosome Aberrations in Human ES

vs. IPS Cells Based On the Method of Their Derivation: ISSCR 8th Annual Meeting, San Francisco, CA June 16-19,

2010

Finger J, Panella J, Wells W, Kositzke B, Borchard, E, Lezama L, Hazelbauer S, Johnson JA, Meisner LF.

Cytogenetic Aberrations in Human ESC and iPSC Lines show Significant Differences: A Comparison of Chromosome

Changes in 1421 iPSC and 1447 ES Cell Lines. ISSCR 9th Annual Meeting, Toronto, CA, 2012.

Borchardt E, Finger J, Meisner L, Johnson JA Misidentification and Cross Culture Contamination of Stem Cell Lines

– A Continuing Problem. ISSCR 9th Annual Meeting, Toronto, CA, 2012

BOOK CHAPTERS

Meisner, LF. and Johnson JA. Protocols for Cytogenetic Study of Human Embryonic Stem Cells. Methods 45:133-

141, 2008

PEER REVIEWED PUBLICATIONS

Sareen D, McMillin E, Eberg A, Shelley B, Johnson J, Meisner L, Svendsen CN. Chromosome 7 and 19 trisomy in

cultured human neural progenitor cells. PLoS One. 2009 Oct29;4(10):e7630.

Mitalipova S, Byrne J, Kuo HC, Johnson JA, Meisner LF, Zeir R, and Wolf DP. Isolation of 20 rhesus embryonic stem

cell lines: Efficiency, karyotype stability and growth characteristics. Stem Cells, 2006.

Chung,Y, Klimanskaya I, Becker S, Marh, J, Lu S, Johnson JA, Meisner L, and Lanza R. Embryonic stem cells

derived from single blastomeres. Nature, October 2005.

Klimanskaya I, Chung Y, Meisner l, Johnson JA, West M, and Lanza R. Human embryonic stem cells derived without

feeder cells. Lancet, 365:1636-1641, 2005

Mitalipova M, Johnson JA, Hoyer D, Jones K, Dalton S, Meisner L, and Stice S. Preserving the genetic integrity of

human embryonic stem cell lines. Nature Biotechnology, 23:19-20, 2005.

Draper JS, Smith K, Gokhale P, Moore HD, Mattby E, Johnson JA, Meisner L, Zwaka TP, Thomson JA, and Andrew

PW. Karyotypic evolution of human embryonic stem cells (ES) in culture: recurrent gain of chromosomes 17 (17q) and

12. Nature Biotechnology, 11(1053-54. 2004

Dewald G, Johnson JA. and 28 others. A multi-center investigation with D-FISH BCR/ABL probes. Cancer Genetic

and Cytogenetics. 2000, 116:97-104.

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