プロフィール詳細

プロジェクトを作成

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Dr. Celine D.に依頼

United States

PhD-level Analytical Chemistry Specialist | HPLC & CE Method Development | Bioanalytical Validation (ICH M10)

プロフィール概要

I am an analytical chemistry specialist with extensive hands-on experience in HPLC, Capillary Electrophoresis (CE), and bioanalytical method development for pharmaceutical compounds and biological matrices. Over the years, I have developed and optimized methods for multi-drug analysis, stability studies, and impurity profiling, and validated these methods according to ICH Q2(R2) and ICH M10 guidelines. My background includes: • Chromatographic separation optimization (HPLC, CE) • Peak resolution improvement & troubleshooting (baseline drift, co-elution, retention shifts) • Buffer and pH screening, surfactant-assisted CE (SDS) • Bioanalytical sample preparation (plasma, serum, milk) • Method validation: linearity, accuracy, precision, recovery, matrix effect, stability • Preparation of SOPs, validation plans, and analytical reports • Experience with pharmaceutical formulation analysis and regulatory-oriented workflows I combine strong theoretical knowledge with practical laboratory experience, enabling me to provide clear, actionable solutions for method development, optimization, and validation problems. I deliver fast, structured, and confidential support tailored to client needs.

専門分野

• ☆ Analytical Chemistry
• ☆ Separation & Purification
• ☆ Liquid Chromatography/HPLC
• ☆ Drug Development
• ☆ Bioanalytical Testing
• ☆ Drug Stability Testing

サービス

• Writing
• Consulting
• Product Development

Writing Technical Writing

Consulting Scientific and Technical Consulting

Product Development Stability/Shelf Life Testing, Product Validation, Quality Assurance & Control (QA/QC)

職務経験

Dr, DMD,PhD

Independent Analytical Chemistry Researcher

8月 2017 - 現在

学歴

PharmD (Doctor of Pharmacy)

USA

1月 2020 - 12月 2024

認定資格

• USA

  x

  1月 2025 - 現在