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
Quality Assurance
Aseptic Process Qualification Trainer
Technical Writing
Quarterly Trending Analysis
Audit Experience
Microbial Identification Write-Ups
Annex 1 and ATMP Gap Assessment Completion
ISO 5 Gowning, BSC and LFG Experience
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