Edmillie J. Jean
Quality Assurance Analyst
Summary
Personable and analytical problem-solver ensuring product quality through productive communication. Ensure team members and company stakeholders are aligned on objectives maintaining gentle leadership. Reviews data to confirm results meet specifications outlined in standard operating procedures (SOPs). Follow SOPs and implement corrective and preventive actions that mitigate potential for issue recurrence. Achieves GMP testing of samples for pharmaceutical clients, meeting all quality and productivity metrics. Demonstrates superior organizational skills, flexibility, and a proven ability to work collaboratively and independently with various company stakeholders.
Overview
5
5
years of professional experience
6
6
years of post-secondary education
1
1
Language
Work History
QC Analyst Clinical Release & Stability
Johnson and Johnson Innovative Medicine
10.2023 - Current
- Foster a productive and efficient working relationship with company stakeholders
- Communicate across adjacent teams to set and develop long-term lab objectives
- Maintain rapport with colleges, managers and senior leaders
- Host quality triage meetings discussing non-conformances to GMP practices
- Public relations coordinator for major DE&I Employee resource group
- Perform a variety of critical assays on new drug products, to ensure purity and quality
- Review and analyze completed labs executions
- Transfer new methods into lab to advance business needs
- Routinely maintain laboratory instruments
- Johnson and Johnson Innovative Medicine
- Collaborated with cross-functional teams to optimize workflows, resulting in improved productivity.
- Drafted technical documents such as deviation reports, testing protocol and trend analyses.
Molecular and Cell Biologist/ Oncology Discovery
Janssen Pharmaceuticals
03.2022 - 10.2023
- Active participant in progressing New drug candidate through Pipeline alongside Project management
- Execute bispecific antibody in vitro assays to progress New Molecular Entities (NME) and Investigational New Drug (IND) projects for clinical trials
- Ran Fluorescence-Activated Cell Sorting (FACs) based low cytometry experiments, cytotoxic assays with effector T-cells, and MSD assays
- Collaborate with Quality Assurance personnel to comply & adhere to cGMP guidelines and regulation for technical reports and QC maps
- Conduct analysis of experimental data to ensure traceability and compliance with FDA guidelines
Cell Biologist/Assay
Code Biotherapeutics
09.2021 - 02.2022
- Company Overview: Development and Discovery
- Responsible for screening of various targeting siRNAs and non-viral plasmid vectors via qPCR, gel electrophoresis and bioluminescent assays
- Efficiently analyzed data to corroborate specificity, and reproducibility while maintaining data integrity
- Passaged and maintained several mammalian cell lines and implemented a lab freezer inventory system
- Development and Discovery
Quality and Development Analyst
Eurofins PSS, Janssen Pharmaceuticals
11.2020 - 09.2021
- Company Overview: Cell Gene Therapy and Vaccine
- Developed and executed validation plans for biotherapeutic drug substances during qualification, validation and transfer of new and existing analytical methods
- Accurately captured analytical data in compliance with applicable GxP, safety, and environmental requirements
- Ran characterization, release, and stability bioassays such as ELISA and FRET to deliver data for regulatory filings in a cGMP environment
- Cell Gene Therapy and Vaccine
Quality Control Developmental Analyst
Tmunity Therapeutics
11.2020 - 03.2021
- ELISA, flow cytometry, and cell-based assays focused on vector isolation, transduction, optimization and development
- Served as the coordinator and assistant manager of LIMS ELN entry system
Forensic Chemistry Technician
NMS Labs
03.2020 - 07.2020
- Reviewed instrument logs and validated reagents required for presumptive and confirmatory tests
- Performed presumptive validation tests and verified balances used for identification and quantification for reagents in casework in compliance to FCC regulations
Education
Master of Science - Forensic Medicine
Philadelphia College of Osteopathic Medicine
08.2017 - 05.2019
Bachelor of Science - Neuroscience
Messiah College
08.2013 - 05.2017
Skills
- Building Interpersonal rapport
- Daily integration of ALCOA in cGMP tasks
- Familiarity with 21 CFR Part 11
- Assay/method development and validation
- SOP development
Timeline
QC Analyst Clinical Release & Stability
Johnson and Johnson Innovative Medicine
10.2023 - Current
Molecular and Cell Biologist/ Oncology Discovery
Janssen Pharmaceuticals
03.2022 - 10.2023
Cell Biologist/Assay
Code Biotherapeutics
09.2021 - 02.2022
Quality and Development Analyst
Eurofins PSS, Janssen Pharmaceuticals
11.2020 - 09.2021
Quality Control Developmental Analyst
Tmunity Therapeutics
11.2020 - 03.2021
Forensic Chemistry Technician
NMS Labs
03.2020 - 07.2020
Master of Science - Forensic Medicine
Philadelphia College of Osteopathic Medicine
08.2017 - 05.2019
Bachelor of Science - Neuroscience
Messiah College
08.2013 - 05.2017
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