Hareish Kumar Thiyagunattamai Mohan
Associate Senior Research Scientist @Eurofins India
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WORK HISTORY
Associate Senior Research Scientist @Eurofins India
Bengaluru, IN
Leading bioanalytical operations and study direction for global biopharmaceutical sponsors with focus on immunogenicity assessment and pharmacokinetic analysis.Key Responsibilities & Achievements- Direct 15+ bioanalytical studies as Study Director/Principal Investigator, achieving 100% regulatory compliance with USFDA, EMEA, and NGCMA standards- Lead 6+ antibody generation projects from immunization through purification, delivering high-quality therapeutic antibodies to global sponsors- Author regulatory-compliant study reports, validation documents, and SOPs supporting successful sponsor reviews and regulatory audits- Mentor 5+ junior scientists in experimental design, data analysis, GLP documentation, and regulatory compliance best practices- Design comprehensive study protocols for pharmacokinetic and immunogenicity assessments, presenting findings to international sponsors- Improve assay throughput by 20% through implementation of optimized workflows and process improvementsTechnical Focus: ELISA method development & validation • MSD electrochemiluminescence • ADA/NAb assays • Pharmacokinetics • Antibody generation & purification • GLP compliance • Regulatory documentation#Bioanalytical #Immunogenicity #ELISA #MSD #StudyDirector #GLP #Pharmacokinetics
EDUCATION
Keck Graduate Institute - Biocon Academy
Certificate Program in Biosciences
Kalasalingam University
Bachelor of Technology (B.Tech.), Biotechnology
ABOUT HAREISH KUMAR THIYAGUNATTAMAI MOHAN
Senior Bioanalytical Scientist | 9 Years | Study Director for 40+ GLP StudiesSpecialized in immunogenicity assessment (ADA/NAb), pharmacokinetics, and ELISA/MSD method development for global biopharmaceutical sponsors.Core Skills: ELISA • MSD Electrochemiluminescence • Ligand Binding Assays • GLP/GMP Compliance • Regulatory Documentation (USFDA/EMEA/ICH) • GraphPad Prism • WATSON LIMSKey Achievements: 100% regulatory compliance across all studies Improved assay throughput by 20% Contributed to 5+ successful regulatory submissions Mentored 5+ scientistsCurrently at Eurofins Advinus | Previously Lambda Therapeutic & Biocon | B.Tech BiotechnologyOpen to Senior Scientist, Principal Scientist, and Study Director roles in India and internationally. t••••••••@gmail.com |+91••••••••25
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