Sujana Pradhan

About Sujana Pradhan

9+ years of experience in CMC dossier preparation, analytical development, specification setting, method validation, method transfer, quality control, analytical project externalization, collaboration with CRO and CDMO business partners, analytical control strategy, analytical manufacturing readiness, technical expert in matrix teams, and analytical workstream leadHighly motivated and ambitious analytical chemistry professional with experience in small molecule, and oligonucleotide drug substance and drug product (ASO & siRNA). Experience in execution of automated liquid handling system coupled to LC-MS systemHands-on experience in metabolite profiling, heavy isotope labeling, solid phase extraction, semi-preparative systems and reverse phase liquid chromatography techniques

Experience

1. Manager, Cmc Regulatory Affairs

   GSK

   Jan 2025 — Present

   Providing strategic regulatory input and leadership on CMC quality dossiers for small molecule, linker-payload and oligonucleotide projects, including collaboration with cross-functional leads to deliver global development activities in compliance with applicable regulatory guidelines. Authoring CTD CMC sections and responses to HAQs, including providing guidance to technical lines on regulatory policies and expectations. Leading strategic development and global submissions of CMC sections of clinical trial applications. As CMC Reg lead, spearheaded storyboarding, planning, authoring, reviewing and approving briefing package for engagement with health authorities, e.g, leading submissions for a novel technology with the Emerging Technology Program at FDA, and effectively preparing GSK teams for agency interactions. Experience with providing regulatory input on change controls and risk assessments, with strong understanding of GMP, FDA, and ICH guidelines. Leading and hands-on experience using digital/genAI/OCR tools to enable automated authoring of NDA/BLA submissions and source documents such as CoAs, specifications and stability reports for ADC projects.

Education

• Saginaw Valley State University

  Bachelor of Science (BS), Biochemistry

  2005 — 2010

• Michigan State University

  Doctor of Philosophy (Ph.D.), Analytical Chemistry

  2010 — 2016

Skills

• Laboratory
• Bioanalysis
• Uv/Vis
• Fluorescence Spectroscopy
• Lc-Ms
• Characterization
• Spectroscopy
• Chemistry
• Laboratory Skills
• Hplc
• Western Blotting
• Metabolomics
• Uv/Vis Spectroscopy
• Cell Culture
• High-Performance Liquid Chromatography (Hplc)
• Analytical Chemistry
• Nmr
• Mass Spectrometry
• Chromatography
• Biochemistry
• Nuclear Magnetic Resonance (Nmr)