Tochi Chinedu
Bound Brook
Summary
Experienced professional with a Master of Business and Science and a background in quality, operations, compliance, and team training. Adept at adhering to procedures, managing workflows, maintaining organization, and collaborating effectively across teams. Committed to delivering results through professionalism, teamwork, and commitment to growth.
Overview
4
4
years of professional experience
1
1
Certification
Work History
Microbiology Specialist, QC Microbiology (CAR-T)
Legend Biotech
09.2024 - 07.2025
- Prepared and reviewed SOPs, protocols, and deviation reports for regulatory compliance.
- Ensured test methods met USP and internal standards.
- Supported audits and regulatory inspections (FDA and global agencies).
- Maintained data integrity per ALCOA+ and 21 CFR Part 11.
- Investigated issues and helped develop CAPAs.
- Performed environmental monitoring, sterility, endotoxin, and microbial ID testing.
- Reviewed nonviable particle counts and IDP data.
- Worked with teams to resolve quality and process issues.
Scientist – QC Microbiology, CAR-T
Bristol Myers Squibb
09.2023 - 09.2024
- Performed sterility, endotoxin, and microbial testing (subculture, gram stain, plate reads, incubations, and transfers)
- Led and supported deviation and CAPA initiatives to resolve complex lab and process issues.
- Trained new hires on lab procedures, compliance, and quality standards.
- Managed multiple projects concurrently, meeting deadlines and quality goals.
- Entered and reviewed data using SAP and LIMS for accuracy and compliance.
- Analyzed and reviewed data to support quality and method validation.
- Led daily huddle meetings to align team priorities and communicate lab updates.
- Collaborated across teams to ensure smooth workflow and regulatory adherence.
Quality Control Biological Scientist (contract)
AbbVie
03.2023 - 09.2023
- Conducted mechanical and tensile testing on AlloDerm and Strattice products.
- Prepared and shipped samples for endotoxin testing with proper labeling and documentation.
- Performed water testing, filtration, and environmental monitoring in aseptic cleanrooms.
- Logged, reviewed, and maintained records/results using LIMS and SAP.
- Supported lab operations, inventory, and equipment upkeep.
- Followed GMP, safety, and documentation standards to ensure compliance.
Cell Lab Specialist
Sampled
10.2021 - 11.2022
- Performed aseptic cell culture testing for client projects, including PBMC and BMMC studies for LOXO and Verily.
- Conducted viability testing using NC-200 and Vi-CELL counters.
- Trained new team members on lab protocols, documentation practices, and data integrity.
- Logged and tracked samples using LIMS; ensured compliance with quality standards.
- Investigated lab process issues and supported continuous improvement efforts.
- Maintained accurate records and addressed discrepancies in testing or documentation.
Education
Business, Biotechnology And Genomics
Rutgers University
New Brunswick, NJ05-2025
Bachelor of Science - Biology
Bloomfield College
Bloomfield, NJ05-2021
Skills
- Team leadership & training
- SOP creation & documentation
- Data review & analysis
- CAPA support
- Policy compliance & safety
- Workflow improvement
- Cross-team communication
- Project support & reporting
- MS Office & Google Workspace
Accomplishments
- Assisted with an investigation project (“Summary Report for Kitting Protocol”) by gathering data, reviewing records, and supporting report development.
- Created action and alert protocols for the launch of a new cleanroom phase.
- Supported multiple investigations and CAPA initiatives to improve regulatory compliance
- Led a startup project (DermaMetrics) for MBS capstone at Rutgers University - New Brunswick, blending biotech innovation with business strategy
- Led an undergraduate GAPDH gene sequencing project, performing DNA extraction, PCR, gel electrophoresis, primer design, Sanger sequencing, Nanodrop analysis, and presenting results to faculty and peers
Certification
- cGMP (Current Good Manufacturing Practice)
- GLP (Good Laboratory Practice)
- GDP (Good Documentation Practice)
- OSHA Safety Training (Hazard Communication, PPE)
- CAPA Process Training
- Embracing Unexpected Change — LinkedIn Learning (Nov 2022)
Timeline
Microbiology Specialist, QC Microbiology (CAR-T)
Legend Biotech
09.2024 - 07.2025
Scientist – QC Microbiology, CAR-T
Bristol Myers Squibb
09.2023 - 09.2024
Quality Control Biological Scientist (contract)
AbbVie
03.2023 - 09.2023
Cell Lab Specialist
Sampled
10.2021 - 11.2022
Business, Biotechnology And Genomics
Rutgers University
Bachelor of Science - Biology
Bloomfield College