Manikanda Prabu M.

About Manikanda Prabu M.

1) Bioanalytical Function Lead with 9+ years experience in Bioanalysis of small and largemolecule in a fully regulated GLP environment.2) Leading team of Scientists for Method development and Method validation and study sample analysis.3) Experienced in facing FDA, ANVISA, UK MHRA and other global regulatory inspections, fully understanding of Compliance requirements.4) Experienced with cell based neutralizingantibody assay & method development.5) Prepared analytical procedures, protocols,SOPs, STP, Reports, audit report closure, database,automatic calculation sheets, spread sheets using MS excels and watson LIMS System.6) Strong Analytical skills with good Knowledge of extraction techniques and ablity to extract compounds from Test Matrix using Liguid Liquid extraction technicques (LLE), Solid phaseextraction (SPE), protein precipitation extraction (PPE) and Double extraction techniques for Derivatizing procedures.7)Performed Data acquisition on Waters (XevoTQS), Sciex(LC-MS/MS- API 5500,API6500),Thermo and Agilent.ICP-MS,LC-MS/MS platforms using Analyst software and Masslynx software, LC quan and Mass Hunter.8) Review of Quality and interpreted bioanalytical data generated accordingly to study protocol and applicable regulatory requirements.

Experience

1. Senior Scientist i

   Althera

   Mar 2025 — Present · Bengaluru, IN

Education

• P.S.R Engineering College, Sivakasi - 626 140

  Bachelor of Technology - BTech

  2011 — 2015

• Karpaga Vinayaga College of Engineering and Technology

  Master of Technology - MTech

  2016 — 2018