Regulatory CMC Professional | Cell & Gene Therapy | Biologics
Biotechnology professional with 3+ years of experience in cell and gene therapy, specializing in CMC regulatory documentation, cGMP manufacturing, and quality systems. Experienced in working with US FDA and CDSCO submissions, with a strong foundation in molecular biology and biologics development.
Research Associate
Authored cGMP documentation including BMRs for NK cell therapy platforms. Contributed to CMC sections for US FDA and CDSCO submissions. Led QMS activities, standardized QC workflows, and supported scale-up of lentiviral vector production.
Scientist
Developed allogeneic NK cell platforms for CMC programs. Optimized scalable manufacturing and analytical methods for release and stability testing. Contributed to IND and MA regulatory documentation for CAR-T therapies.
Project Associate-I
Worked on HFSP-funded RNA World project involving construct design, IVTT, ribozyme synthesis, and molecular optimization. Managed lab operations, procurement, and grant coordination.
Integrated M.Sc. in Science (Chemistry Major)
Developed autologous and allogeneic NK cell platforms with focus on CMC, regulatory documentation, and scalable manufacturing under cGMP conditions.
Conducted advanced molecular biology experiments including STITCH PCR, IVTT systems, and RNA synthesis to study early molecular evolution mechanisms.