1. Susan Cho Hicks, CGMBS, MB(ASCP)
14739 High Valley Road, Poway, CA 92064 · (858) 334-3852 · shicks403@gmail.com
1
Summary of Qualifications
Director of Laboratory Operations with experience in the clinical, biotechnology, and research fields.
Specializing in startup environments for the emerging disciplines of next generation sequencing, non-
invasive prenatal testing, and oncology. Seasoned inspector for the College of American Pathologists.
Major strengths include technical expertise, laboratory management, leadership, quality, and regulatory
experience.
Professional Experience
Sequenom Laboratories. San Diego, CA 11/2011 – present
Sequenom Laboratories is a CAP-accredited and CLIA-certified molecular diagnostics company
dedicated to the development and commercialization of laboratory-developed tests (LDTs) for prenatal
diseases and conditions using circulating cell-free fetal nucleic acids.
Associate Director, Laboratory Operations 03/2016 – present
Senior Clinical Laboratory Manager, Technical/Operations 03/2015 – 03/2016
Clinical Laboratory Manager, Technical/Operations 03/2013 – 03/2015
Clinical Laboratory Supervisor, Technical 11/2011 – 03/2013
 Manage laboratory development and daily laboratory operations
 Provide oversight for analytical problem solving, strategic planning, and process improvement
 Monitor and report performance metrics to ensure quality and consistency of data
 Project management, scheduling, and monitoring for rapid laboratory growth and expansion
o Oversee sample volume growth from launch in 2011 to ~150k samples/year (2015)
o Validation and launch of North Carolina laboratory site (2013)
 Process validation, assay optimization, and method transfer
o Validation and implementation of MaterniT21 PLUS Laboratory Developed Test
 Assay versions 1, 2, 3, and 4
o Validation and implementation of GENOME, VisibiliT, RHD, and CF LDTs
o Validation and implementation of automated laboratory processes
o Implementation of Chain of Custody processes to ensure sample identity
o Technology transfers to international and domestic licensing partners
 Maintain appropriate laboratory accreditation and quality assurance programs
 Inspect and audit laboratory sites to ensure compliance and inspection preparedness, from product
development to commercialization, and through post-launch
 Establish and maintain effective, cross-functional collaborative working relationships:
o with Research and Development for the transition of new technology to the clinical lab
o with Bioinformatics for monitoring of longitudinal data, improvement of algorithms, and
implementation of pipeline revisions
o with Information Technology in the creation and improvement of LIS/LIMS interfaces
o with Business Development and Marketing for the promotion of Sequenom technology to
potential clients and/or physicians
 Develop materials for studies, reports, and educational materials for presentation to internal and
external audiences
 Maintain staffing by interviewing, hiring, training, and competency assessment of personnel
 Oversee management and qualification of equipment and inventory

2. Susan Cho Hicks, CGMBS, MB(ASCP)
14739 High Valley Road, Poway, CA 92064 · (858) 334-3852 · shicks403@gmail.com
2
bioTheranostics, Inc. San Diego, CA. 10/2009 – 11/2011
Clinical Laboratory Scientist
 Perform testing for the CancerTYPE ID assay – for use in tumor specimens from patients diagnosed
with malignant disease, to aid in the classification of the tissue of origin and tumor subtype
 Develop, validate and implement new assays – KRAS, BRAF
 Create protocols for assays, validations, and in-house studies
 Perform all aspects of daily bench work:
o KRAS, BRAF, EGFR– ABI 7900HT
o Manual and automated DNA and RNA extraction from FFPE – QIAGEN, Zymo
 Prepare and submit Test Approval Submissions and Responses to New York State
 Prepare for CAP, NYS laboratory inspections
 QA/QC/QM for equipment, reagents, supplies, assays
 Train, monitor, and assess competency and proficiency testing
 Laboratory Information System point-of-contact
 Oversee clinical laboratory relocation, including coordination of physical move, verification testing and
documentation for all assays
Scripps Clinic Medical Laboratories. San Diego, CA. 04/2006 – 10/2009
Clinical Laboratory Scientist II, Molecular Testing/Microbiology
Roche Diagnostics Molecular Center of Excellence (MCOE)
 Develop and implement assay validations
 Create protocols for assays, validations, and in-house studies
 QA/QC for equipment, reagents, supplies, assays
 Train, monitor, and assess staff competency and proficiency
 Perform all aspects of daily bench work:
o HSV 1/2, GBS, GAS, VZV, Staphylococcus, mecA - Roche LightCycler 1.2, 2.0
o HIV, HCV - Roche COBAS Ampliprep / COBAS TaqMan 48
o CT/NG – Genprobe Aptima
o Influenza A, Influenza B, RSV – Prodesse proFLU
o Robotic extraction – Roche MagNA Pure and Tecan Freedom Evo
Westcliff Medical Laboratories, Inc. Santa Ana, CA. 2/2003 – 03/2006
Senior Technologist, Molecular Biology Department
 Established department in 2003
 Develop and implement assay validations
 Create protocols for assays, validations, and in-house studies
 Establish, implement, and maintain quality control records
 Operate, troubleshoot, and maintain COBAS Amplicor instrumentation
 Train new staff and evaluate staff competency
 Perform all aspects of daily bench work:
o Qualitative CT/NG and quantitative HIV - Roche Amplicor, COBAS and microwell plate
o HCV quantitation - Bayer bDNA

3. Susan Cho Hicks, CGMBS, MB(ASCP)
14739 High Valley Road, Poway, CA 92064 · (858) 334-3852 · shicks403@gmail.com
3
Long Beach Memorial Medical Center. Long Beach, CA. 8/2002 - 12/2002
Laboratory Technician, Hematology and Urinalysis Departments
 Maintained a smooth workflow for the second largest private hospital on the west coast
Geneva General Hospital. Geneva, NY. 5/2002 - 7/2002
Medical Technologist, Generalist
 Performed tests in chemistry, serology, urinalysis, and special chemistry
Specialty Laboratories. Santa Monica, CA. 7/2001 - 5/2002
Laboratory Technician, Molecular Genetics Department
 Performed esoteric assays by manual methods
 Techniques employed:
o DNA extraction, quantitation and digestion
o DNA amplification by PCR, analysis by gel electrophoresis
o Signal amplification by Invader
o Laboratory Developed assays performed:
 Factor V (Leiden and HR-2), Factor II Prothrombin, B27, Apo E, CCR-5, MTHFR,
Celiac, Narcolepsy, ColIAI
Soldiers and Sailors Memorial Hospital. Penn Yan, NY. 10/1999 - 6/2001
Medical Technologist, Generalist
 Performed tests in hematology, chemistry, serology, urinalysis, coagulation, special chemistry, blood
gases and blood bank
City University of New York, Queens College. New York, NY. 7/1991 - 9/1993
Microbial Genetics Research, Department of Biochemistry
 Research using Saccharomyces cerevisiae and Escherichia coli to study DNA repair, recombination,
and stability of double-stranded breaks induced by restriction enzyme
 Techniques employed: Cell culture, spheroplast transformation, Southern blot

4. Susan Cho Hicks, CGMBS, MB(ASCP)
14739 High Valley Road, Poway, CA 92064 · (858) 334-3852 · shicks403@gmail.com
4
Education
 Binghamton University. Binghamton, NY. 1997. Bachelor of Science in Biology
 UC San Diego Extension. San Diego, CA. 2012. The Manager’s Toolkit: A program for managers
with emphasis on team development, management style, personal growth, communication style,
leading and facilitating teams.
 The Leadership Edge. San Diego, CA. 2013. From Lab to Leadership. A program developed
exclusively for managers in the life science and medical device industries to turn science-minded
managers into capable business leaders.
 The Green Belt Six Sigma Toolkit. Sigma Quality Management. 2014.
Licenses and Certifications
 Clinical Genetic Molecular Biologist Scientist. License # MTP 143, State of California
 Technologist in Molecular Pathology. License # MB (ASCP) 108, ASCP
 Clinical Chemist Scientist. License # MTC 600, State of California
 Certified Laboratory Specialist in Molecular Biology. Certification # 9910401, NCA
Quality and Regulatory Experience
 College of American Pathologists (CAP) Inspector for Molecular Pathology, subspecialties of
Molecular Genetics and Infectious Diseases. 05/2009 – Present
 Extensive knowledge of CAP, CLIA, New York State, and FDA regulations
Publications and Abstracts
Non-Invasive Prenatal Testing (NIPT) using the MaterniT21 PLUS Test: The clinical experience. Saldivar
JS, McCullough RM, Hicks SC, Oeth P, Bombard AT. American College of Medical Genetics Annual
Clinical Genetics Meeting. March 19-23 2013. Phoenix, AZ.
Noninvasive prenatal testing (NIPT) in multiple gestations: A report of laboratory experience. Bombard
AT, McCullough R, Hicks S, and Saldivar JS. American College of Obstetricians and Gynecologists 61
st
Annual Clinical Meeting. May 4-8 2013. New Orleans, LA.
Factors affecting circulating cell-free fetal DNA. Saldivar JS, Geis JA, Hicks SC, Bombard AT. American
College of Obstetricians and Gynecologists 61st Annual Clinical Meeting. May 4-8 2013. New Orleans,
LA.
McCullough RM, Almasri EA, Guan X, Geis JA, Hicks SC, et al. (2014) Non-Invasive Prenatal
Chromosomal Aneuploidy Testing - Clinical Experience: 100,000 Clinical Samples. PLoS ONE 9(10):
e109173. doi:10.1371/journal.pone.0109173