QC Senior Associate Scientist (CAR-T Cell Therapy, Bio-analytical) - Bristol Myers Squibb - Warren, NJ
(2021-04)
- Bioanalytical QC testing and reporting for clinical cell therapy products
- Performs in-process, final product, and stability sample testing to support clinical release of cell therapy products.
- Utilizes analytical methods including ELISA, Flow Cytometry, qPCR, and aseptic technique.
- Operates under GMP and GDP regulations to ensure compliance and product quality.
- Authors and reviews technical documents such as SOPs, test methods, and stability protocols/reports using Veeva.
- Conducts deviation (QE), CAPA, and OOS investigations to support continuous improvement and regulatory compliance.
- Serves as Subject Matter Expert (SME) responsible for training new employees.
- Participates in QC group meetings and cross-functional projects to drive collaboration and process optimization
QC Serologist II – Reagent Red blood Cell - Ortho Clinical Diagnostics (Johnson & Johnson) - Raritan, NJ
(2010-07 - 2021-04)
- Performed serological testing of biological raw materials and blood bank reagents.
- Conducted in-process, release, stability, and customer complaint testing.
- Conducted testing on Ortho AutoVue Innova and ProVue systems.
- Maintained and troubleshot laboratory equipment to ensure optimal performance.
- Reviewed documentation in accordance with approved procedures and GMP standards.
- Served as Subject Matter Expert (SME) responsible for training new employees.
- Conducted batch record review and participated in non-conformance (NC) and CAPA investigations.
- Managed scheduling and coverage for two laboratories to ensure continuous operations.
