MBA, MT(ASCP)
Resume:
PATRICIA PARK
San Lorenzo CA **580
Phone: 510-***-**** (home)
Mobile: 650-***-****
Email:**********@*****.***
CA CLS MTA36900
MT-ASCP 02656695
Summary:
Broad range of experience in business and science, from research and
development to implementation and testing. Always looking to learn, improve
my knowledge base, share experiences, and advance my career while making a
difference in the world . Seeking a position in a laboratory with cutting-
edge technology that can help deliver a change in paradigm by delivering
personalized medicine to a much needed system.
25 years of clinical laboratory and government regulated environment (CLIA,
CAP, FDA, EPA, CDER, CBER, cGMP)
10+ years at supervisor/ management level experience.
Experience implementing new laboratory procedures and instrumentation,
including methods, quality control and validation.
Experience in Lean six sigma and lab design.
MBA, Certified MT(ASCP) California licensed CLS.
Knowledge and experience in regulatory requirements for Molecular methods
including NexGen Sequencing.
Knowledge and experience in process validation and Diagnostic Lab developed
tests
Experience in budgeting, planning, cost accounting, contract negotiation
and process mapping.
Experience in CLIA, CAP, and ISO15189 accreditation maintenance and
implementation.
Experience in Quality Systems implementation and auditing
Experience in design for continuous improvement and control including QC
program design, CAPA evaluation, root cause analysis, and Deviation
technical evaluation in Research, Pharmaceutical and Clinical labs
Experience
Lab Manager National Labs, Hayward CA Dec 2013 - March 2015
Responsible for all systems and technical lab operations in a Startup
Clinical Lab focused on Pain Management and Drug confirmatory testing. Took
an Empty lab space, built the technical team, infrastructure, and processes
from supplies to personnel. Obtained CLIA registration and COLA
certification for a growing and profitable section of laboratory testing in
less than 6 months. Designed and implemented 1-QC program, 2-QA program, 3-
Vendor audits 4- LIS set-up and implementation of Lab Health (purchased LIS
system). Wore all hats from testing personnel, Tech transfer, and Quality
Management.
CLS QA Technical Supervisor, Feb 2012-Dec 2013. helped to bring up a new
CLIA lab in a NexGen platform and align current process with international
regulatory ISO standards by managing all aspects of a CLIA technical
supervisor for a whole human genome testing. I am Responsible for oversight
and performance of the daily operations of a clinical reference laboratory,
developing and validating new clinical applications of whole genome
sequencing, orchestrating confirmatory testing, training technical and non-
technical staff, technical troubleshooting and ensuring a high quality of
services under the advise of the consulting Laboratory Director. Initiated
and aided in change control, personnel compliance and SOP restructuring,
selection of the test methodology that is appropriate for the clinical use
of the test results, verification of the test procedures performed and
establishment of the laboratory's test performance characteristics
including the precision and accuracy of each test and test system,.
Additional responsibilities include creation, enrollment and participation
in an approved proficiency testing program commensurate with the services
offered, establishing a new quality control program, ensuring that
appropriate quality system levels are maintained throughout the entire
testing process from the initial receipt of the specimen, through sample
analysis and reporting of test results, evaluation and resolution of
corrective and preventative action (CAPA), and process deviations,
identifying training needs and maintaining a training program., evaluating
the competency of testing personnel and assuring that the staff maintain
their competency according to CLIA regulations. Currently designing QC
program and performing GAP analysis for ISO 15189 implementation.
Clinical Laboratory Supervisor, and Lead Clinical lab scientist PM shift
Palo Alto Medical Foundation, Palo Alto, CA. Dec 2006-2012. Responsible for
the day to day operations of a general clinical lab servicing 650
physicians and over 100,000 patients with over 65 direct reports including
CLS, Lab Assistants and Medical support clerks. Responsibilities were
numerous and included scheduling, writing and reviewing SOPs, QA/QC
tracking and report generation including remedial actions, trending and
resolution of technical and personnel problems. Performed Annual personnel
evaluations, hiring, and training for 65 direct reports. Took
responsibility for lab redesign for expansion and volume scale up to triple
volume. As the lead, other requirements included bench testing, technical
review and problem resolution of multiple instruments and analytical
platforms. Administrative duties included 1)Ordering and stocking supplies,
2) Daily, weekly, and monthly review of QC including problem resolution,
3)Action plans and investigations of failures, trends, and shifts. 4)
Training and competency of personnel,
Sr. Clinical Laboratory Scientist, Virology Laboratory, Stanford University
Medical Center, Stanford CA: Nov. 2003-Dec 2006. Perform daily diagnostic
and research testing as well as customer service to both a large hospital
and community physicians base from a state of the art clinical virology
laboratory. Experience includes RT-PCR, DNA,RNA extractions and
quantitation using both automated and manual procedures for in-house
validated protocols and viral load testing. Serology using rapid detection,
immunoflourescence, and automated methods, Branch DNA, molecular assays and
sequencing, Tissue culture, Viral Identification by Direct fluorescent exam
and viral culture.
Lead Technologist: Satellite Laboratories, Redwood City, CA. June 2003-
November 2003. Responsible for all laboratory functions including
troubleshooting and problem solving in a dialysis laboratory that assays
high volume bulk diagnostic testing. Including instrumentation QC, sample
receiving and computer correlation in Chemistry, Immunoassay, Hematology
and Environmental areas of the laboratory. Instrumentation includes Advia,
Nichols Advantage, Stago coag, Variant HPLC, Mass Spec, LAL testing,
Centaur, Immunlite, And Olympus analyzers.
Associate Director Sales and Marketing, Girindus Inc.: June 2002-Mar 2003:
Reporting to the Vice President of Business Development, responsible for
leading the organization's marketing and customized process manufacturing
programs to outsourcing companies through each phase of new product
development from preclinical through market.
Sales Executive/Associate Business Development, Bachem Americas: December
2000- May 2002: Responsible for international sales of immunological assay
kits, peptide catalogue products and laboratory cGMP services producing
API's.. Serving a territory that compromised west of the Mississippi to
Asia.
Sales Representative, Columbia Diagnostics Inc: A division of Fisher
Healthcare, Sep.1999 - Dec.2000: Responsible for distribution and technical
sales of laboratory specialty supplies and equipment to hospitals, clinics,
physicians offices, veterinarians, and research institutes in a six county
area of Northern and Central California.
Physicians Office Laboratory (POL) Consultant(ASCP) 1995-1997(in
conjunction with employment at Chiron). Co-owner and partner of a POL
consultant business offering licensed training and advice to Physicians
office laboratories for both moderately complex, CLIA-waived and rapid
laboratory diagnostics. Marketed and sold all aspects of business
including design and implementation and distribution of all marketing
materials, cold calling on physicians and lab managers and maintenance of
web site. Consulted on an as-needed basis for training, instrumentation and
CPT coding to help physicians become profitable and maintain accurate
quality lab systems. Sold business to partner when returning to school for
and MBA while working full time.
Supervisor; QC-Therapeutics Immunoassay, Chiron Corporation, Emeryville
California, Dec.1995-Sep.1999. Responsible for insuring accurate and timely
testing of therapeutic drug products in a cGMP immunoassay laboratory with
three analysts by insuring analyst compliance, training, development and
continued education are performed in an efficient and cost effective manner
while maintaining a controlled and quality work environment. Duties
included scheduling release and stability testing, and analysts duties;
performing ELISA, slot blots, total DNA assays, and calibration of
instrumentation according to SOP's; signature review of all paperwork
according to GMP and FDA guidelines; troubleshooting problem assays,
trending and cross-validation of reagents; validation of assays including
precision, accuracy, reproducibility, linearity, quantification, and
robustness using the appropriate statistical software packages, working
with development, manufacturing and research in using their expertise to
transfer new product assays that are properly controlled and acceptable for
filing NDA's, and IND's, writing and reviewing SOP's, special reports,
validation reports and investigations, and total quality management of all
laboratory functions including LIMS, SAP, and CIS validation and
implementation.
Research Biologist/ Microbiologist, U.S. Environmental Protection Agency,
Research Triangle Park N.C. 1989-1995. Assisted in the choice of
experimental approaches and techniques for several different types of
complex experiments and assays to examine and develop methods for assessing
effects of chemicals and pollutants on the immune system. Required writing
and editing SOP's and animal protocols, performing immunotoxicity testing,
analyzing and reporting results to supervising committees using EPA/GLP
guidelines. Have prepared and presented posters for national conferences,
co-authored journal manuscripts and technical reports and interfaced with
quality assurance, health and safety, and animal control personnel to fully
integrate their expertise into ongoing activities. Responsibilities
included ordering and maintaining disposable supplies for a multi-personnel
research team, maintaining cell lines and stock bacterial cultures and
initiating research in a new molecular /PCR lab. Instrumentation and Assays
include. DNA and RNA extraction; RT-PCR; gel electrophoresis; UV
photography; RIA; light microscopy; fluorescent microscopy; centrifugation
ultracentrifugation, and cytocentrifugation; ELISA; macrophage
phagocytosis; bacterial growth and quantitation; RNA quantitation; cell
counts and differentials; gram stains, fluorescent stains, Diff-Quick and
specialized cellular stains; tissue culture; viral plaque assays; Animal
procedures included antigen and drug dosing (intraperitoneal, aerosol, and
IV); lung lavage; tissue fixation; bleeding (cardiac puncture and tail
vein); and necropsy of tissues.
Medical Laboratory Technologist, Family Planning Clinic, Wake County Health
Department, Raleigh N.C., 1993-1995. Employment concurrent with EPA
employment. Performed Laboratory testing in a clinic setting including
urinalysis, hemoglobin, hematocrit, wet-prep/KOH, and veinipuncture.
Maintained quality control and patient results on laboratory log to insure
proper QA and computer entry for laboratory following OSHA and CLIA
guidelines.
Medical Office Laboratory Technologist, Dr's Urgent Care Centre, 4100 Wake
Forest Rd., Raleigh, N.C. 1992-1993. Employment concurrent in time with EPA
employment. Performed laboratory test in a clinic setting including
urinalysis, CBC's, differentials, wet-preps, gram stains, glucose,
veinipuncture, disinfection of surgical instruments, and drug screen
collections with a chain of custody. Also responsible for receptionist and
nursing duties as needed including billing using CPT codes, specimen
collection, EKG, hearing tests, blood pressure and pulse screening and eye
test. While there I authored the only procedure manual and obtained MSDS's
to fulfill OSHA requirements.
Medical Laboratory Technologist, Clinical Microbiology, North Carolina
Memorial Hospital, Chapel Hill, N.C., 1988-1989. Night shift technologist
in charge of Microbiology-Immunology laboratories. Duties included
supervising two other employees to insure rapid turnaround of specimen
collection and set-up, interpretation of blood cultures, gram stains, and
rapid tests. Communicated with physicians on call to correlate new positive
cultures with patient treatment. Performed c-difficile toxin assays, Kirby-
Bauer sensitivities and was responsible for maintaining manual records and
proper computer entry.
Medical Technologist, Memorial Hospital of Martinsville-Henry County,
Martinsville Va.,1987-1988.Generalist, second and third shifts in both the
main and stat labs. Duties consisted of all aspects of clinical laboratory
work including, data entry, specimen collection, test performance, and
interpretation, veinipuncture, quality control, and charting results.
Instrumentation included ACA, TDX, TLA, Cobas BIO, MLA, Coulter Counter,
Gamma Counter, and Coagamate. Performed manual blood bank procedures
following FDA and CLIA guidelines.
Research Assistant, Dr. E. Lacey, University of North Carolina at
Greensboro, Department of Biology, Greensboro, N.C., 1985-1986. Evaluated
plant structure and growth across various environments to assess
evolutionary trends. Duties included setting up field plots, counting
carrot seeds, measurement of root diameter at various growth timepoints and
elevation levels, collection and analysis of data using SAS and filing
results.
Education
MBA: University of Phoenix, 1999
BS Medical Technology,
BA Biology; University of North Carolina at Greensboro and Moses Cone
Hospital, Greensboro, N.C.
Continuing Education courses
Too much to list
Certification
MT-174108 (ASCP)
Clinical Laboratory Scientist (CLS)-California License MTA 36900
Publications
Gilmour, M.I., Park, P.A., Selgrade, M.J.K. Strain Differences to Ozone
Enhanced Streptococcal Infection are Conserved with Phosgene and Nitrogen
Dioxide Exposure (The Toxicologist 1997).
Gilmour, M.I., Park, P.A., Selgrade, M.J.K Upregulation of Immune Responses
to House Dust Mite Antigen in Brown Norway Rats Exposed to 5ppm Nitrogen
Dioxide (Inhalation Tox. 1998).
Prichard, Robert J., Ghio, Andrew J., Piantadosi, C.A., Winsett, D.W.,
Tepper, J.S., Park, P.A., and Gilmour, M.I., Oxidant Generated Complement
Activation and Lung Injury by Particulate Air Pollutants Increase with the
Concentration of Iron. (Inhalation Tox. 1996).
Gilmour, M.I., Park, P.A., Selgrade, M.J.K Ozone-Enhanced Pulmonary
Infection with Streptococcus zooepidemicus in Mice. Am. Rev. Resp. Dis.
Vol.147p.753-760, 1993.
Gilmour, M.I., Park, P.A., Selgrade, M.J.K Factors Affecting the
Suppression of Antibacterial Defenses in Mice Exposed to Ozone. Exp. Lung
Res 19:299-314. 1993
Dong, Wumin., Selgrade, M.J.K., Gilmour, M.Ian., Park, Patricia, Luster,
Michael I., and Kari, Frank W. Altered Alveolar Macrophage Function in
Calorie-restricted Rats. Am. J. Respir. Cell Mol. Biol. 19:142-146, 1992
Abstracts/Presentations
Park, P.A., and Selgrade, M.J.K., 1995. Host Resistance to Bacterial,
Viral, and Tumor Cell Challenge Following Exposure to Wood Stove and Oil
Furnace Emissions. The Toxicologist vol. 15 no. 1 (Quoted in Science
vol.267 Mar 24, 1995).
Park, P.A., Selgrade, M.J.K., Gilmour, M.I., 1994. The Effects of VOC
Mixtures on Susceptibility to Bacterial Infection. The Toxicologist vol. 14
no. 1.
Gilmour, M.I., Park, P.A., Selgrade, M.J.K., 1994. Exacerbation of Immune
Response to Dust Mite Antigen in Rats Exposed to Nitrogen Dioxide. The
Toxicologist vol. 14 no. 1.
Park, P.A., Selgrade, M.J.K., Gilmour, M.I., 1993. Pulmonary Defenses to
Streptococcal Infection Following Acute Exposure to Trichloroethylene or
Chloroform. The Toxicologist vol. 13 no. 1 332.
Gilmour, M.I., Park, P.A., Selgrade, M.J.K., 1993. Recruitment of PMN's
During Oxidant-Induced Infection in Rats is Required for Controlling
Streptococcal Infection. The Toxicologist vol.13 no. 1 1660.
Gilmour, M.I., Park, P.A., Selgrade, M.J.K., 1992. A Comparison of
Pulmonary Defenses Against Streptococcal Infection in Rats Following Ozone
Exposure. The Toxicologist vol.12 no. 1.
Gilmour, M.I., Park, P.A., Selgrade, M.J.K., 1991. Assessment of
Antibacterial Defenses Following Ozone Exposure. The Toxicologist vol. 11
A445.
Gilmour, M.I., Park, P.A., Selgrade, M.J.K., 1991. Mouse Strain Differences
Affect Enhanced Susceptibility to Respiratory Infection Following Exposure
to Oxidant Gasses. The Toxicologist vol.11 A841.
Gilmour, M.I., Park, P.A., Selgrade, M.J.K., 1991. Mechanism for Enhanced
Susceptibility to Infection in Mice Exposed to Ozone. Am Tox. Soc. National
Meeting.
Gilmour, M.I., Park, P.A., Selgrade, M.J.K., 1991. Development of a Murine
Model to Asses the Effects of Inhaled Pollutants on Dust Mite Allergy.
Sixth Annual Symposium Foundation for Immunotoxicology.
References
Available upon request.[pic]
Contact this candidate