Senior Molecular Laboratory Leader and Compliance Expert

DINITHI N. PERERA

***** ******* *****, *******, ** 832-***-**** *********@*****.***

PROFESSIONAL PROFILE

Accomplished laboratory executive with over 10 years of leadership and hands-on expertise in high-complexity molecular and genetic laboratories. Physician-trained (MBBS) and ASCP–MB certified, combining deep scientific knowledge with strong operational, regulatory, and quality leadership. Proven ability to build, scale, and optimize clinical laboratories—from bench- level molecular testing to assay validation, regulatory compliance, and enterprise-level laboratory management. Experienced in leading multidisciplinary teams, implementing efficient workflows, and maintaining inspection-ready operations under CLIA, CAP, and COLA standards. Recognized for driving sustainable laboratory growth, operational excellence, and business value in both startup and established laboratory environments. Areas of Expertise:

High-Complexity Molecular Laboratory Development & Management Technical & General Supervision (CLIA / CAP / COLA) Assay Development, Validation & Verification

Quality Assurance, Quality Control & Compliance

Regulatory Audits & Proficiency Testing (CAP, COLA) Standard Operating Procedures (SOP) Development & Review Project Management & Workflow Optimization

Cost Control, Purchasing & Vendor Management

Staff Training, Competency Assessment & Leadership Laboratory Information Systems (LIMS)

Medical Billing & Reimbursement Support

Troubleshooting & Root Cause Analysis

EDUCATION & CREDENTIALS

M.D. (MBBS)

University of Sri Jayewardenepura, Sri Lanka August 2002 Medical Council Registration

Sri Lanka Medical Council March 2005

(to practice Medicine in Sri Lanka)

ECFMG Certification

USMLE Step 1 January 2009

USMLE Step 2 CS (Clinical Skills) December 2011

USMLE Step 2 CK (Clinical Knowledge) July 2011

USMLE Step 3 September 2012

ASCP-MB September 1st, 2016

Lean Six Sigma Green Belt November 1st, 2019

Florida Molecular Supervisor License March 14th, 2025 PROFESSIONAL EXPERIENCE

Technical /General Supervisor

Elite Clinical Laboratory – Tampa, FL

3/2025 –2/2026

In my roles as Technical/General Supervisor and Quality & Compliance Manager, I have been responsible for regulatory compliance, quality systems, assay validation, staff competency, and operational oversight across multiple molecular platforms. My contributions have strengthened quality performance, ensured successful proficiency testing participation, and supported scalable, compliant laboratory operations across locations. Key Responsibilities:

Led the production team and set goals for performance and deadlines.

Responsible for all quality assurance monitoring of operational processes and applicable performance indicators.

Trained the staff and maintained their competencies to perform tests accurately.

Wrote and revised SOP’s, validation reports, and quality and assurance documents.

Reviewing and Submitting Proficiency Testing results.

Successfully completed the COLA Audit.

Quality and Compliance Manager

Elite Clinical Laboratory – Houston, TX

3/2024–2/2026

Key Responsibilities:

Regulatory Compliance: Monitor and ensure compliance with all relevant clinical laboratory regulations.

SOP Management: Develop, review, and update standard operating procedures, providing staff training to ensure consistent application. Ensure that all SOPs are followed correctly and consistently across the organization.

Quality Assurance & Quality Control: Coordinate with different departments to implement quality checks and periodically review internal processes to identify areas of improvement.

Compliance Issues: Promptly address compliance issues, document and report incidents, implement corrective actions, and create plans to prevent recurrence.

Audit & Reporting: Conduct internal audits, address non-compliance, and report findings to senior management. Other Duties:

Played a major role in validating the PGX assay and preparing the validation reports.

Assist with Training new staff members on PCR Assays and completing the competencies.

Contribute to meeting production requirements and troubleshooting issues. Assist in production requirements by Analyzing PCR runs and helping with the wet lab as needed Lab Manager and Technical Supervisor

TopBlood Laboratories – Sugarland, TX

07/2023 –2/2024

Provide operational and technical leadership for TopBlood Laboratories, overseeing daily operations, laboratory expansion, and toxicology testing using Indiko Screening Analyzer and Agilent LC/MS platforms. Implemented efficiency-driven process improvements while aligning laboratory practices with organizational objectives to support high-quality, scalable diagnostic services.

Key Responsibilities:

Oversaw all aspects of day-to-day laboratory operations, including toxicology testing workflows, staff coordination, and operational planning to ensure efficient and compliant laboratory performance.

Led laboratory expansion and development initiatives, supporting growth in testing capacity, infrastructure, and workflow optimization aligned with organizational objectives.

Directed toxicology testing operations utilizing Indiko Screening Analyzer and Agilent LC/MS systems with MassHunter software, ensuring accurate, reliable, and timely test results.

Implemented streamlined operational and analytical processes that improved efficiency, turnaround time, and overall testing throughput within the toxicology department.

Ensured laboratory practices complied with applicable regulatory requirements, quality standards, and internal policies, maintaining inspection readiness and consistent quality performance.

Developed, reviewed, and maintained standard operating procedures (SOPs) related to toxicology testing, instrumentation, and workflows.

Collaborated with leadership and cross-functional teams to align laboratory operations with TopBlood Laboratories’ strategic goals and service delivery objectives.

Supported quality assurance activities, including troubleshooting analytical issues, monitoring performance indicators, and implementing corrective actions when needed. VP of Operations & Lab Manager/Technical Supervisor Rapid Dx Laboratories – Houston, TX

12/2020 –06/2023

Rapid Dx is a startup laboratory created at the peak of the COVID-19 pandemic. As VP of Operations and Lab Manager, I oversee most aspects of day-to-day operations, completely responsible for developing and managing the laboratory. Built and scaled Rapid Dx Laboratories to high operational and regulatory standards, enabling the company to be profitably acquired at the end of the COVID-19 testing cycle, while many peer laboratories exited the market through closures or distressed sales. Key Responsibilities:

Validate assays for COVID-19, flu/COVID-19, respiratory pathogen panel (RPP), urinary tract infection (UTI), Sexually transmitted infections Pathogen Panel (STI) and pharmacogenomics (PGX). Validations were done in the most cost-effective methods.

Completely managed the COLA Audit and got the lab qualified with zero deficiencies.

Successfully managed the lab to handle extremely high volumes received during COVID 19 spikes.

Write, revise, and maintain SOP’s, policies, validations, and new workflow processes.

Track supply levels and order lab supplies, reagents, and consumables.

Train new lab staff on assay workflow, monitor and evaluate their competency, and provide feedback.

Manage Critical, noncritical Instrument maintenance in a timely manner. Ordered Proficiency Testing for all assays.

Assist with Marketing group to onboard more accounts.

Work with the billing company to get the reimbursements on time.

Successfully worked with other labs in getting reference lab partnerships accounts. Director – Quality Assurance

AccessDx Laboratories – Houston, TX

06/2020 –12/2020

Played a major role in expanding AccessDx to a 24/7/365 continuously working laboratory to cater to the sudden COVID-19 testing demands. Successfully operated the lab, processing 5,000 to 7,000 samples a day with a 24-hour turnaround time

(TAT).

Key Responsibilities:

Responsible for all quality assurance monitoring of operational processes and applicable performance indicators.

Developed, applied, and maintained quality assurance practices.

Ensured that all lab policies, procedures, and operation executions complied with CLIA regulations and company policies.

Responsible for submitting CAP Proficiency Testing for all assays including Pharmacogenomics (PGX), Cancer Genomics, COVID-19, and Respiratory Tract Infections (RPP) according to CAP guidelines.

Provided quality input, review, and approval for all SOP’s, policies, validations, and new workflow processes.

Ensured appropriate quality control systems were in place for every operational system.

Oversaw the collection, evaluation, and distribution of quality tracking and trending data, and maintain regular communication of quality analysis to management.

Collaborated with department managers to identify, develop, and implement process improvements to ensure stable quality performance based upon performance data.

Implemented the yearly quality-assurance, quality-improvement plan in conjunction with company goals and policies.

Assisted operations staff with quality metrics, policy development, training, competency, and education of staff. In addition to the above responsibilities as QA Director, I took on the following additional responsibilities to facilitate AccessDX’s expansion to a 24/7/365 continuous laboratory in order to cater to the COVID-19 testing demands.

Led Data Entry Team to overcome a huge backlog which was the bottleneck of the laboratory, by directly taking the team under my management, restructuring the team, hiring new staff and training them, and directly scheduling and assigning the work until the entire backlog was cleared – smooth operation was established within 3 weeks.

Worked with subcontractors and managed them.

Managed the ordering of lab supplies, reagents, and consumables.

Led instrument maintenance scheduling.

Trained new lab staff on assays as needed.

Trained new Data Entry and Reporting staff.

Quality Assurance Manager/General Supervisor

ApolloDx – Houston, TX

11/2019 - 05/2020

The company was a startup laboratory at the time of hire. Worked with a skeleton crew to complete validation studies and develop the laboratory to an operational condition. Key Responsibilities:

Managed and validated PGX, CGX, RPP and COVID-19 assays that included design of experiments, SOP developments, training and managing lab staff to do the bench work, data analysis, and creating reports. Submitted EUA application for COVID-19.

Led the production team and set goals for performance and deadlines.

Assisted in hiring new staff by evaluating their resumes and interviewing them.

Trained the staff and maintained their competencies to perform tests accurately.

Wrote and revised SOP’s, validation reports, and quality and assurance documents.

Managed vendors, including requesting quotations and making decisions to reduce cost of supplies while getting high quality products.

Managed equipment maintenance.

General Supervisor

AccessDX – Houston, TX

08/2017 - 11/2019

Promoted to General Supervisor at AccessDX. Led PGX and CGX production teams.

Trained the staff and maintained their competencies to perform tests accurately.

Set goals for performance and deadlines. Evaluated staff after 60 days, 6 months, and yearly to evaluate their work.

Utilized the Ovation LIMS (Laboratory Information Management System) to improve automated solutions for workflows.

Wrote and revised SOP’s, validation reports and quality and assurance documents.

Managed vendors, which included requesting quotes, evaluating products, gauging value, and making decisions to reduce cost of supplies while getting high quality products.

Oversaw equipment maintenance.

Performed a validation study that enabled extending the acceptancy period of a buccal swab from 60 to 90 days. Molecular Technologist

AccessDX – Houston, TX

11/2016 - 08/2017

Performed high complexity genetic tests in the clinical lab environment for pharmacogenomics including DNA extraction using Beckman FX liquid handling instrument, assays of Open Array, Copy Number, and Single Tube

Screened toxicology samples in Mindray and confirmed using Shimadzu instruments

Performed dry swab extraction validation using Beckman extraction reagents

Achieved competency in operating and troubleshooting all the equipment in the entire lab. LMD/Laboratory Technologist

CompanionDx – Houston, TX

11/2014 - 10/2016

Managed Laser Micro Dissection (LMD) operations

Trained new team members on LMD slide preparation and slide scanning using Aperio CS2 scanner. Medical Practice

Medical officer – Family Medicine Lanka Hospital LTD, Sri Lanka 06/13 - 09/13 Medical officer - Surgical and Radiology Asiri Surgical Hospital LTD, Sri Lanka 06/13 - 09/13 Intern House Officer in General Surgery Teaching Hospital Batticaloa, Sri Lanka 09/04 - 03/05 Intern House Officer in Pediatric Teaching Hospital Batticaloa, Sri Lanka 03/04 - 09/04 Research Associate

University of Colombo (Dept. of Chemistry) – Sri Lanka 01/1995 - 12/1995

Other Achievements

Chess Club Treasurer

T.H. Rogers Elementary and Middle School – Houston, TX 2014 - Present

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