Summary
Overview
Work History
Education
Skills
Relevant Coursework
Timeline
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Natasha Hovey

QA Microbiologist II
3109 Wildwood Court, Monmouth Junction

Summary

Current QA Microbiologist with distinguished knowledge of CAR-T production. Working in an exempt level position with responsibilities for providing microbiological oversight and contamination control of the production of CAR-T products commercial operations in a controlled cGMP cleanroom environment. Detail oriented and excellent work ethic demonstrated over 3 years of industry experience.

Overview

4
4
years of professional experience

Work History

Microbiology Specialist II

Legend Biotech
03.2023 - Current
  • Work with Quality and Operations teams to monitor and audit the aseptic operations and processes in support of aseptic manufacturing of Car T products.
  • Edit or review and approve relevant GMP documents, SOP’s and WI’s.
  • Actively support Process microbiological investigations.
  • Support the Plant Microbiologist in ensuring the microbiological control strategy is consistent with cGMP company requirements.
  • Manage Aseptic Process Qualification program and schedule qualifications for personnel.
  • Identify risks and opportunities in relation to contamination control on the shop floor and drive follow up initiatives for improvement in close cooperation with operators, QC and operations management.
  • Work on gap and risk assessments with quality to ensure compliance with major regulatory agencies (ANVISA, ATMP, Annex 1)
  • Drive strategy improvements related to the reduction of contamination risks and the improvement of microbiological hygiene.

Manufacturing Technician

Bristol Myers Squibb
12.2020 - 03.2023
  • Review master batch records, labels, and other drug product documentation for compliance with FDA regulations.
  • Worked in clean room ISO 5 Grade A (BSC) environment where critical parts would require personnel monitoring with QC Microbiology to ensure sterility.
  • Performed aseptic handling of final drug product under FDA and cGMP regulations. Final drug product would be given to cancer patients.
  • LIMS and CeLabs experience with creating, generating, and collecting samples.
  • Performed Environmental Monitoring of manufacturing operations facility in ISO 5 environment
  • Managed company operations by verifying all completed documents, while following SOP and GMP regulations
  • Recommended and implemented in-process and laboratory improvements for compliance and GMP.
  • Worked on CAR-T Operations

Laboratory Technician

Rutgers University
06.2020 - 07.2021
  • Receive, label and analyze human samples.
  • Processing samples for presence of SARs-CoV-2 RNA using ranges of specialized techniques
  • Use qPCR assay for determining results on gene expression and genotype analysis
  • Design and execute laboratory testing according standard procedures, make observations and interpret findings.
  • Record all data and results in specified forms (paper and electronic) with accuracy and responsibility.
  • Proper handling of COVID samples, performing extractions, LIMS data entry, qPCR analysis.
  • Managed over 10,000 samples per day, exceeding mandatory productivity rates

Education

Bachelor of Science - Biology

St. John’s University
Jamaica, Manhattan, NY
Aug 2016 - 05.2020

Skills

    ISO 5 Gowning, BSC Experience

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Relevant Coursework

Lab Applications and Techniques I (2020)

  • Analysis of Enhanced Green Fluorescent Protein
  • Gel Electrophoresis
  • SDS-PAGE
  • PCR
  • Western Blot
  • IPTG

Timeline

Microbiology Specialist II

Legend Biotech
03.2023 - Current

Manufacturing Technician

Bristol Myers Squibb
12.2020 - 03.2023

Laboratory Technician

Rutgers University
06.2020 - 07.2021

Bachelor of Science - Biology

St. John’s University
Aug 2016 - 05.2020

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Natasha HoveyQA Microbiologist II