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@olufunmilolaibironke
Analytical cell biologist with expertise in assay development.
United StatesI am an analytical and cell biologist with over a decade of experience in designing, developing, and validating analytical methods and cell-based potency assays within GMP and GLP environments. My work has primarily focused on CAR-T therapy, protein expression, and regulatory-compliant assay development for biologics. I pride myself on my proven track record in scientific leadership, team supervision, and cross-functional collaboration, all while maintaining a commitment to scientific excellence and operational efficiency.
In my current role as a Principal Scientist at Novartis Pharmaceuticals, I lead the design and validation of CAR-T potency assays and sterility testing, ensuring compliance with GMP standards. My experience includes developing and optimizing various assays, including ELISA and qPCR, to support IND submissions. I have also supervised technical teams and contributed to method transfers to QC, demonstrating my ability to manage complex projects and drive results in a collaborative environment.
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Work history, roles, and key accomplishments
Novartis Pharmaceuticals
Feb 2022 - Present (3 years 9 months)
Led design and validation of CAR-T potency assays, sterility testing, and immune profiling in compliance with GMP. Developed and optimized ELISA, qPCR, cytotoxicity, and flow-based assays supporting IND submissions. Supervised technical teams and served as HSE and Green Lab liaison.
Bristol Myers Squibb
Sep 2021 - Present (4 years 2 months)
Led sterility and mycoplasma assay development (qPCR/ddPCR) in a QC environment. Developed and qualified analytical methods across multiple therapeutic areas. Conducted NGS library preparation and primary immune cell (PBMC) handling for potency studies.
Rutgers University
Jan 2018 - Present (7 years 10 months)
Directed ex vivo immunological assays and cytokine analyses using R/Prism. Developed lab procedures, trained junior researchers, and ensured GLP compliance. Led multiple DOD-funded projects exploring host-microbiome-metabolism interactions.
Rutgers University
Jan 2015 - Present (10 years 10 months)
Developed cell-based assays and RNA/protein expression methods to study T-cell responses under pollutant exposure. Utilized siRNA knockdown and glucose starvation models in breast cancer cells.
Degrees, certifications, and relevant coursework
HUCertificate, Biotechnology Management
Currently enrolled in a certificate program focused on biotechnology management. Developing expertise in strategic leadership and operational aspects pertinent to the biotechnology industry.
RUCertificate, Data Science
Acquired practical skills in data science through a dedicated certificate program. Focused on programming languages such as Python and R, alongside database management using SQL for data analysis and manipulation.
JUCertificate, Vaccine Development
Completed a specialized certificate program in vaccine development. Studied key principles and practices in immunology and public health related to vaccine research and production.
RUPhD, Physiology and Integrative Biology
Conducted extensive research in molecular biology and immunology, focusing on T-cell responses to pollutant exposure. Developed and utilized cell-based assays and RNA/protein expression methods, including siRNA knockdown and glucose starvation models in breast cancer cells.
JHMS, Molecular Microbiology and Immunology
Completed a Master of Science degree specializing in molecular microbiology and immunology. Gained in-depth knowledge and practical skills in advanced microbiological techniques and immunological principles relevant to public health.
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