Manikandan T

About Manikandan T

Analytical Research Scientist with 6+ years of experience in pharmaceutical API development and CDMO operations within cGMP-regulated environments. Specialized in Gas Chromatography (GC-FID, GC-ECD, GC-MS, Headspace GC) for residual solvent analysis and impurity profiling. Strong expertise in analytical method development, validation (ICH Q2), stability studies, investigation handling, and regulatory documentation supporting global submissions.Scientifically driven professional with strong interest in Drug Product Analytical R&D and Drug Discovery research environments, particularly in LC-MS–based impurity characterization, trace-level analysis, degradation pathway investigation, and MS/NMR-supported structural elucidation. Passionate about contributing to early-phase development, medicinal chemistry support, and innovation-oriented pharmaceutical research programs.

Experience

1. Analytical R & d Scientist

   TAPI

   Jul 2021 — Present · Delhi, IN

   Perform residual solvent determination using GC-FID and Headspace GC as per ICH Q3C guidelines.Utilize GC-MS for identification and characterization of unknown impurities and degradation products.Develop, optimize, verify, and validate GC methods in accordance with ICH Q2 guidelines.Optimize chromatographic parameters including temperature programming, carrier gas flow, and column selection.Execute system suitability testing and ensure instrument performance compliance.Troubleshoot chromatographic issues such as resolution failure, peak tailing, ghost peaks, and baseline instability.Manage calibration, preventive maintenance, breakdown handling, and change control documentation.Support API development, stability studies, and impurity profiling activities.Support CDMO projects involving client-specific analytical deliverables and documentation.Lead OOS, OOT, and LIR investigations with structured root cause analysis and CAPA implementation.Prepare and review SOPs, STPs, validation protocols, analytical reports, and regulatory documentation (DMF / ANDA).Ensure compliance with ALCOA+, 21 CFR Part 11, cGMP, and ICH guidelines.Collaborate with QA, QC, Manufacturing, and Regulatory teams.Mentor junior analysts and promote GMP and data integrity culture.

Education

• Pondicherry University

  Master of Science - MS, chemical science

  2013 — 2015

• St.joseph's college of arts and science

  B.sc, Chemistry