Naga Selvaraj
Frederick,USA
Summary
Biopharma leader with 15+ years of oncology research and 8+ years directing cell & gene therapy (CGT) GMP manufacturing and CMC programs. Expert in strategic project leadership, IND-enabling documentation, regulatory compliance (FDA/ICH), and CDMO partnerships. Proven track record delivering plasmid, mRNA, viral vector, CAR-T, and TCR-T therapies through Phase I/II clinical milestones. Recognized for cross-functional leadership, client engagement, and risk-managed execution of multimillion-dollar GMP programs.
Overview
15
15
years of professional experience
1
1
Certification
Work History
Principal Scientist / Development Scientist III, Project Lead
Leidos Biomedical Research, Inc.
09.2021 - Current
- Directed 8+ concurrent GMP programs (plasmid, mRNA, viral vectors, CAR-T, TCR-T), managing timelines, resources, and deliverables using MS Project and Smartsheet.
- Led end-to-end program execution from process development through GMP manufacturing, ensuring alignment with CMC milestones.
- Delivered 12+ clinical trial products on schedule, supporting client development budgets exceeding $10M.
- Coordinated across QA, QC, RA, Manufacturing, Finance, and Business Development to achieve project goals.
- Represented project progress in executive reviews and client meetings, ensuring transparency, alignment, and confidence in program delivery.
- Simplified complex scientific processes (gene editing, viral vectors) for diverse stakeholders.
- Reviewed and approved batch records, assay specs, and COAs, ensuring quality compliance.
- Acted as supply chain SME, accelerating procurement of GMP-grade raw materials through vendor negotiations.
- Optimized project management infrastructure by introducing standardized trackers, SOPs, and documentation systems.
- Built and scaled automated GMP processes (Prodigy, G-Rex), improving efficiency, scalability, and cost-effectiveness.
- Strategic Project Leadership
- Operational Oversight & Continuous Improvement
Senior Scientist / Process Development Scientist II
Leidos Biomedical Research, Inc.
01.2017 - 08.2021
- Developed autologous and allogeneic CGT platforms including AAV, VLPs, and chimeric antibodies.
- Optimized AAV9-DMD and AAV2-AADC production platforms; contributed to FDA approval of AAV2-AADC (Kebildi).
- Authored CMC Module 3 documentation, QC protocols, COAs, and supported IND submissions.
- Directed innovation projects introducing automated manufacturing systems, conducting feasibility, risk, and cost assessments.
- Produced and purified 500 mg EBV2 VLPs for Phase I vaccine trial; contributed to nanoparticle vaccine research.
- Led assay development and tech transfer to QC (FACS, cytotoxicity, qPCR, MLR).
- Managed GMP operations, production planning, and supply chain logistics, ensuring uninterrupted clinical material delivery.
Postdoctoral Research Associate, Glioblastoma
01.2015 - 04.2015
- Developed ADAR protein purification methods; advanced understanding of RNA editing mechanisms.
Postdoctoral Fellow, Prostate Cancer
Indiana University School of Medicine
12.2010 - 12.2014
- Led research on ETS gene role in prostate cancer; authored 4 peer-reviewed publications (3 first-author).
- Characterized signaling pathways (RAS/ERK, PI3K/AKT) and mentored graduate/postdoctoral researchers.
Education
Ph.D. - Genomics & Proteomics
Bharathiar University
India01.2010
Skills
- Project & Program Management
- GMP Manufacturing & Tech Transfer
- IND/CMC Documentation
- Regulatory Compliance (FDA/ICH)
- Viral Vectors, Plasmid, mRNA, CAR-T/TCR-T
- ATMPs
- Budget Oversight & Vendor Negotiation
- MS Project, Smartsheet, SharePoint, Teams
- Cross-Functional Leadership
- Client Engagement & Executive Communication
Websites
Affiliations
Committees: Active with HESI CT-TRACS, NIST Flow Cytometry Consortium, Gene Delivery WG, Standards Coordinating Body (SCB).
Certification
- Regulatory Affairs Certificate: Pharmaceuticals, RAPS Online University (2024)
- AI & Career Empowerment Certification, Univ. of Maryland – Smith School of Business (2025)
- PMP Certification – In Progress
Publications
- Selvaraj N. et al. Scalable Viral Vector Upstream Process for AAV Gene Therapy Manufacturing. Human Gene Therapy (2021).
- Selvaraj N. et al. MAPK Specificity in ETS Transcription Factor Function in Prostate Cells. Cell Communication and Signaling (2015).
Awards
Finalist, Special Achievement Award – CGT Projects, Leidos Biomedical (2024), Team Award, CAR-T Cell Therapy Program, Leidos Biomedical (2020)
Timeline
Principal Scientist / Development Scientist III, Project Lead
Leidos Biomedical Research, Inc.
09.2021 - Current
Senior Scientist / Process Development Scientist II
Leidos Biomedical Research, Inc.
01.2017 - 08.2021
Postdoctoral Research Associate, Glioblastoma
01.2015 - 04.2015
Postdoctoral Fellow, Prostate Cancer
Indiana University School of Medicine
12.2010 - 12.2014
Ph.D. - Genomics & Proteomics
Bharathiar University