Summary
Overview
Work History
Education
Skills
Accomplishments
References
Timeline
Generic

Helvert Martinez

Leominster

Summary

Experienced quality analyst/scientist in multiple assay processes including human cell cultures, flow cytometry, qPCR, cell viability and RNA/DNA extraction, in addition to SOP writing/revision and assay transfer support. Skill sets mainly focused on immunology and oncology assays in GMP and GLP settings. Prior managerial experience in CLIA laboratory for diagnostic testing of viral and bacterial pathogens.

Overview

4
4
years of professional experience

Work History

Quality Control Analyst II

Mustangbio
02.2022 - 04.2024
  • Perform release testing of CAR-T drug product for patients in clinical trials and Fibroblast and IPSC cell line products for CDMO client
  • Provide scheduling of assays to QC department
  • Author and review laboratory-specific processes and procedures, such as standard operating processes and work instructions, this includes new cell culture lines, flow cytometry and qPCR assays
  • Support Analytical development of assay transfers by performing dry runs of newly written SOPs including cell culture, flow cytometry and qPCR assays
  • Assist in data review of product release for patients and generation of product COAs
  • Cross-train other QC analysts in molecular assays and cell culture assays involving aseptic techniques
  • Support QC investigations including deviations, OOS and CAPA implementation
  • Perform maintenance of QC equipment and instruments
  • Manage and organize department samples
  • Assist in the implementation of LIMS system for QC department
  • Maintain up to date stock of reagents used for molecular and cell culture assays and other related assays
  • Assemble raw materials qualification per SOPs
  • Maintain and review logs for usage of instruments and equipment in QC lab.

Group lead

Quest Diagnostics
12.2020 - 02.2022
  • Operate moderate complexity instruments such as Hamilton, MagNa Pure 96, ABI thermal Cycler, Panther and Biofire
  • Perform required maintenance on the instruments for optimal performance
  • Performing quality control testing for reagents to maintain compliance with SOP and CLIA regulations
  • De-swabbing patient samples for Hamilton instrument
  • Perform qRT-PCR and release of patient results
  • Creating PCR-mix and performing quality control test
  • Taking inventory for reagents
  • Monitoring laboratory refrigerators, freezers, and room humidity through ISENSIX system
  • Diverting workflow to appropriate platforms to ensure TAT
  • Training new medical technologists on instrument usage and maintenance
  • Ensuring electronic quality control logs are up to date
  • Answering client calls regarding testing criteria.

Medical Technologist I

Quest Diagnostics
05.2020 - 12.2022
  • Build Sample into workloads for appropriate testing platform
  • De-swab patient sample for Hamilton instrument before RNA extraction
  • Operate MagNaPure 96 instrument to perform RNA extraction of patient samples
  • Create Master-Mix reagent for use in RT-PCR
  • Operate Hamilton instrument of PCR plates for transfer of patient material before thermocycler
  • Operate thermocycler instrument used for RT-PCR.

Education

MS - Biotechnology and Biomedical Engineering

University of Massachusetts, Dartmouth

BS - Biology

Worcester State University

Skills

  • QPCR
  • Flow Cytometry
  • Mammalian Cell Culture
  • DNA/RNA Extraction
  • Viability
  • Visual Appearance
  • CFU-C
  • Sample management
  • Assay transfer support
  • SOP author and revision

Accomplishments

  • Successfully provided support in releasing 30,000 patient results during the COVID-19 pandemic in a 24hour time period.
  • Provided support in validating the first FDA approved pool testing procedure for COVID-19 testing.

References

Available upon request.

Timeline

Quality Control Analyst II

Mustangbio
02.2022 - 04.2024

Group lead

Quest Diagnostics
12.2020 - 02.2022

Medical Technologist I

Quest Diagnostics
05.2020 - 12.2022

MS - Biotechnology and Biomedical Engineering

University of Massachusetts, Dartmouth

BS - Biology

Worcester State University

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Helvert Martinez