Saikat Chakraborty

I worked as a Principal Scientist in CMC Analytical Development with 15+ years of experience across cell & gene therapy, viral vectors, and monoclonal antibodies, specializing in molecular and cell-based analytical methodologies that support development from early research through GMP manufacturing.

My core strength lies in molecular analytics, including infectious titer, VCN determination, ddPCR/qPCR-based assays, and viral vector characterization, with hands-on experience across AAV, lentiviral, retroviral vectors, and mAbs. I am most effective in roles requiring deep technical ownership, sustained assay lifecycle management, and close engagement with data, methods, and regulatory expectations.

At Elanco, I lead analytical development efforts for monoclonal antibody programs, focusing on CQA-driven method development, reference standard lifecycle management, stability programs, and CRO/CDMO oversight. Previously, in gene therapy-focused roles, I developed, qualified, and validated molecular and cell-based assays supporting viral vector potency, safety, and comparability in both GLP and GMP environments.

I thrive at the intersection of science, CMC strategy, and execution, enabling robust analytical control strategies that ensure product quality, regulatory compliance, and efficient progression from R&D to GMP.