Clinical Laboratory Lab

VAN J MANLAPAZ, CLS MT (ASCP)

*******@*****.*** CP: 408-***-****

SUMMARY

** ***** ** ********** **** extensive knowledge in technical, managerial skills, assay validation and regulatory accreditation process.

Experienced in fast-paced challenging, highly complex laboratory settings on NGS molecular, chemical, biological, hematological, immunologic, microscopic, and bacteriological, laboratory instrumentation, method principles and techniques.

Committed to continuous improvement, proactively identify and plan, implement strategies enhancing efficiency and consistency in setting goals and projects.

PROFESSIONAL EXPERIENCE

Clinical Lab Scientist, Sr. Lab Manager

(01/2022 – Present) - DiaCarta Inc, Clinical Laboratory, Pleasanton, CA

Responsible for managing the clinical laboratory performance.

Lead and support initial inspection audits for CAP and NY inspection preparation. Assist in interactions with submissions to activities required to support all necessary licensure for the clinical laboratory.

Perform high complex molecular genetic tests including DNA/RNA extraction, PCR, and Next Generation Sequencing on patient specimens including all steps from sample processing to result reporting as per the company SOP.

Bring forth the specialized scientific and technical knowledge essential to perform lab testing.

Successfully complete all proficiency testing, prior to submission to the Laboratory Director.

Support the company’s Quality Management System activities to ensure compliance with all local, state, and federal regulations.

Responsible for creating a validation plan, performed in assay validation studies of lab developed tests with the approval of the Laboratory Director.

Demonstrate the ability to maintain competency and take on training responsibilities as needed. Annual personnel performance evaluations and documentation of testing personnel performance competency.

Experienced in process improvement, troubleshooting and corrective and preventive actions.

Lead & support processes such as document control, reagent release, QC review, corrective and preventive action (CAPA), non-conformance management, and change control management.

Perform troubleshooting, maintenance, and problem resolution.

Perform other duties as assigned and assist others as time allows.

Clinical Lab Scientist, Technical Lab Supervisor

(09/2019 – 01/2022) - Predicine Labs, Hayward, CA

Responsible for supervising the performance of a novel clinical test for the diagnosis of SARS-CoV-2 (Covid-19) by RT-PCR.

Performed high complex molecular genetic tests including DNA/RNA extraction, PCR, and Next Generation Sequencing on patient specimens including all steps from sample processing to result reporting as per the company SOP.

Performed and managed operational plans and timelines to achieved on time on validation study completion.

Successfully complete all proficiency testing, prior to submission to the Laboratory Director.

Maintain pertinent records according to the Quality Management plan to ensure compliance with all local, state and federal regulations.

Performed assay validation studies of lab developed tests with the approval of the Laboratory Director.

Demonstrate the ability to maintain competency and take on training responsibilities as needed.

Perform troubleshooting, maintenance, and problem resolution.

Perform other duties as assigned and assist others as time allows.

Sr. Clinical Lab Scientist

(11/2018- 3/2019) - Sequoia Hospital, Redwood City, CA.

Maintains records that demonstrate proficiency testing samples are tested in the same manner as patient samples.

Performed chemical, biological, hematological, immunologic, microscopic and bacteriological in clinical laboratory

Adheres to the laboratory policies and procedures calibrations and maintenance performed.

Processed more than 2000 specimens a day on inpatient and outpatient.

Knowledge of Slide maker stainer Beckman Coulter, AU 680 Beckman Coulter, Unicel Dxl 600 access immune, ACL top 500, IRICELL complete urinalysis and IRIS iChemVelocity IQ 200 Series

Assists the lead CLS in reviewing and solving quality control problems, quality control policies whenever test systems are not within the laboratory’s established levels of performance.

Clinical Lab Scientist

(11/2018- 06/2019) - Trident Diagnostic Lab, San Leandro, CA. Reference Lab (Per Diem) –

Check and verify all the test results, requesting redraw for verification, canceling results due to gross hemolysis, clots or QNS.

Follows the laboratory’s quality control policies whenever test systems are not within the laboratory’s established levels of performance.

Maintains records that demonstrate that proficiency testing samples are tested in the same manner as patient samples.

Worked with instruments such as ; Unicel Dxi 600 access immune, AU800, Sysmex

Processed 3000 specimen a day.

Clinical Lab Scientist/Gen. Supervisor

(10/2017- 08/2018) – Medgenome Lab, Foster City, CA

Validated and implemented NGS testing in the Clinical Lab.

Accession, handling, and processing samples,

Extracting DNA from tumor blocks and slides, Library preparation, target enrichment and Sequencing.

Writing SOP for clinical lab procedures.

Maintain all equipment in the Lab such as Illumina Novaseq, Miseq, Covaris Sonicator, Qubit, Agilent Tapestation and Veriti thermal cycler.

Responsible for day-to-day supervision or oversight of the laboratory operations and personnel.

Responsible for monitoring test analysis and specimen examinations to ensure that acceptable levels of analytic performance are maintained

Clinical Lab Scientist/Gen. Supervisor

(01/2017- 10/2017) -Toray Molecular Oncology, Brisbane, CA

Performed laboratory testing as necessary to meet deadlines.

Write and review standard operating procedures.

Monitor the temperature throughout the laboratory.

Maintain proficiency testing subscription records and submit copies of patient evaluations to the Lab Manager and Director in a timely manner.

Validated and implemented NGS testing in the Clinical Lab.

Clinical Lab Scientist I

(11/2012- 09/2015) Natera Labs, San Carlos, CA

Performed high complexity on Non-Invasive Prenatal testing Carrier Screening and by DNA extraction, PCR, purification of amplified DNA analysis from whole blood samples using Hamilton microlab STAR automation.

Independently identified and troubleshooting high complexity issues adversely affect the test performance.

Document corrective actions taken when test systems deviate from the laboratory’s established performance specifications.

Reviewed and documented laboratory quality control, actions taken when test systems deviate from the laboratory.

Proficient in operating with instrument: AB 3730XL, DNA analyzers, Beckman Coulter NxP and FxP, Qiacube, QiaSymphony and Illumina Hi-sequencing, DNA quantification using Nanodrop.

Performed laboratory testing as necessary to meet deadlines.

Write and review standard operating procedures.

Monitor the temperature throughout the laboratory.

Maintain proficiency testing subscription records and submit copies of patient evaluations to the Lab Manager and Director in a timely manner.

Reference Lab Technician/ Phlebotomist

(12/2003- 11/2012) Stanford Medical Center, Palo Alto, CA

Performed Phlebotomy on outpatients and inpatients.

Received and accessioning STAT specimens as preparation to be sent out for testing to Reference Lab as ordered by Physician.

Check and modify specimens received, processed Blood Bank and HLA donor testing in a timely manner.

EDUCATION

CLS - UC Berkeley, CA- June 2010

B.S. in Biology Centro Escolar University

LICENSE (CA)

CLS -Generalist – MTA-00044313 exp 07/30/2026

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