Matthew Lachenauer
Livingston
Summary
QC Analytical Senior Specialist specializing in CAR-T cell therapy within cGMP environments. Expertise in flow cytometry, ELISA, and PCR supporting clinical and commercial release. Proven contributor to production scale-up, data integrity initiatives, and cross-site training. Recognized SME with experience in trending, investigations, and regulatory readiness. MBA candidate focused on pharmaceutical leadership and operational strategy.
Overview
7
7
years of professional experience
1
1
Certification
Work History
Senior Specialist, QC Analytical
Bristol Myers Squibb
Summit, NJ
08.2022 - Current
- Execute and review QC analytical testing (Flow Cytometry, ELISA, PCR) supporting CAR-T clinical and commercial release operations
- Support production ramp-up for Breyanzi through workflow optimization and lab efficiency improvements
- Serve as QC SME for global Data Integrity Risk Assessments, supporting audit readiness and regulatory compliance
- Lead quarterly data trending and control charting to monitor assay performance and identify process improvements
- Author and revise SOPs, protocols, and GMP documentation within Infinity systems
- Initiate and support deviations, investigations, and CAPAs to ensure product quality and compliance
- Train and mentor new hires and cross-site personnel on QC methods, GMP practices, and assay execution
- Support cross-site training initiatives, including Abecma personnel onboarding for Breyanzi ramp-up
- Develop lab materials (e.g., BOM creation) to support manufacturing scale-up
Flow Cytometry Specialist
WuXi AppTec
Philadelphia, PA
05.2021 - 07.2022
- Performed flow cytometry, ELISA, and cell-based assays under cGMP for CAR-T development and release
- Supported assay development, validation, stability, and release testing within a CDMO environment
- Trained analysts on flow cytometry and ELISA methods
- Operated FACS Canto, Lyric, and Verse using FACSDiva and FACSuite
Medical Laboratory Scientist
Nemours Children’s Hospital
Wilmington, DE
08.2019 - 05.2021
- Performed QC testing and flow cytometry for cellular therapy processing
- Supported transition to electronic laboratory systems (ELS)
- Performed cell sorting, sterile processing, and sample handling for clinical therapies
- Maintained GMP-like compliance and laboratory readiness
Education
MBA - Pharmaceutical Management
Fairleigh Dickinson University
BS - Medical Laboratory Science
University of Delaware
Skills
- Analytical thinking
- Data Trending and Analysis
- Process Improvement and Operational Support
- Training and SME Leadership
Certification
MLS (ASCP)
Timeline
Senior Specialist, QC Analytical
Bristol Myers Squibb
08.2022 - Current
Flow Cytometry Specialist
WuXi AppTec
05.2021 - 07.2022
Medical Laboratory Scientist
Nemours Children’s Hospital
08.2019 - 05.2021
BS - Medical Laboratory Science
University of Delaware
MBA - Pharmaceutical Management
Fairleigh Dickinson University