プロフィール詳細

プロジェクトを作成

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Avinash G.に依頼

India

Bioanalytical Scientist | LC-MS/MS Method Development & Validation | Data Integrity | AI Integration | GLP/GCP

プロフィール概要

🔬 I’m a senior Bioanalytical Scientist with 15+ years of experience in LC-MS/MS method development, validation, and bioanalysis under strict GLP/GCP and 21 CFR Part 11 compliance. 🧪 I’ve worked extensively with Sciex, Agilent, and Shimadzu HPLC systems, applying extraction techniques like LLE, SPE, and PPT across complex biological matrices. 📊 My expertise includes ensuring audit-ready documentation, traceable data, and full regulatory alignment with USFDA, EMEA, and MHRA requirements. ⚙️ I also help labs and CROs integrate AI-powered workflows and automate routine processes to improve efficiency and reduce compliance risk. 📁 I offer end-to-end services including method development, raw data review, SOP writing, audit prep, and digital lab consulting. 🤝 I work with CROs, biotech startups, and clinical research teams who need high-quality, reproducible, and regulator-approved analytical results—on time, and with full transparency.

専門分野

• ☆ Analytical Chemistry
• ☆ Spectrophotometry
• ☆ Mass Spectrometry
• ☆ Liquid Chromatography/HPLC

サービス

• Writing
• Research
• Consulting
• Data & AI

Writing Clinical Trial Documentation

Research Technology Scouting, Gray Literature Search, Scientific and Technical Research

Consulting Scientific and Technical Consulting, Regulatory Consulting

Data & AI Data Processing

職務経験

Research Scientist

Accutest (India)

- 現在

Research Scientist - I

Accutest Research Laboratories India Private Limited

7月 2024 - 7月 2025

Senior Research Associate

Synapse Labs Pvt Ltd

6月 2021 - 10月 2024

Senior Research Associate

Accutest Research Laboratories India Private Limited

6月 2016 - 6月 2021

Senior Analyst

Raptim Research Pvt.Ltd

1月 2014 - 5月 2016

Research Associate I

Synapse Labs Pvt. Pvt

2月 2009 - 12月 2013

学歴

M.Sc (Master of Science)

Vinayaka Mission's Research Foundation-Deemed University - India

6月 2009 - 6月 2011

Batchelor of Science

Solapur University - India

6月 2005 - 6月 2008

認定資格

• GLP and GDP Training

  Accutest Research Laboratories

  1月 2025 - 現在

• LC-MS/MS Operation & Troubleshooting

  Accutest Research Laboratories

  1月 2025 - 現在

• Microsoft AI & Machine Learning Engineering

  coursera

  1月 2025 - 現在