Bioanalytical Scientist - Pearl River
Only for registered members Pearl River, United States
2 days ago
Position Summary · The Bioanalytical Scientist is responsible for developing, validating, and executing bioanalytical methods to support preclinical and clinical studies. This role ensures accurate quantification of drugs, metabolites, and biomarkers in biological matrices while ...
The Bioanalytical Scientist is responsible for developing, validating, and executing bioanalytical methods to support preclinical and clinical studies.
Method Development & Validation
Develop, optimize, and validate bioanalytical methods using LC-MS/MS, ELISA, ligand-binding assays, or HPLC.
Perform method qualification and validation following regulatory guidelines (FDA, EMA, ICH).
Troubleshoot analytical methods and improve sensitivity, accuracy, and reproducibility.
Sample Analysis & Data Generation
Analyze biological samples (plasma, serum, urine, tissues) for pharmacokinetic (PK) and biomarker studies.
Process and extract samples using protein precipitation, SPE, or liquid-liquid extraction.
Ensure timely and accurate data generation for preclinical and clinical studies.
Instrumentation & Laboratory Operations
Operate and maintain analytical instruments including LC-MS/MS, HPLC, GC-MS, and immunoassay platforms.
Perform system suitability checks, calibration, and routine maintenance.
Ensure compliance with GLP/GMP and laboratory safety procedures.
Data Analysis & Documentation
Analyze and interpret bioanalytical data using software such as Analyst, Watson LIMS, or Phoenix WinNonlin.
Prepare technical reports, validation protocols, and study summaries.
Maintain proper documentation for regulatory audits and submissions.
Cross-functional Collaboration
Collaborate with pharmacokinetics, toxicology, clinical, and regulatory teams.
Support IND/NDA submissions and regulatory filings.
Communicate results and scientific findings to stakeholders.
Required Qualifications
MS or PhD in Bioanalytical Chemistry, Pharmaceutical Sciences, Biochemistry, or related field.
2–8+ years of experience in bioanalytical method development and sample analysis.
Strong experience with LC-MS/MS and ligand-binding assays.
Knowledge of GLP/GMP and regulatory guidelines.
Job description
Position SummaryThe Bioanalytical Scientist is responsible for developing, validating, and executing bioanalytical methods to support preclinical and clinical studies.
This role ensures accurate quantification of drugs, metabolites, and biomarkers in biological matrices while maintaining compliance with regulatory and GMP/GLP standards.
Key ResponsibilitiesMethod Development & Validation
Develop, optimize, and validate bioanalytical methods using LC-MS/MS, ELISA, ligand-binding assays, or HPLC.
Perform method qualification and validation following regulatory guidelines (FDA, EMA, ICH).
Troubleshoot analytical methods and improve sensitivity, accuracy, and reproducibility.
Sample Analysis & Data Generation
Analyze biological samples (plasma, serum, urine, tissues) for pharmacokinetic (PK) and biomarker studies.
Process and extract samples using protein precipitation, SPE, or liquid-liquid extraction.
Ensure timely and accurate data generation for preclinical and clinical studies.
Instrumentation & Laboratory Operations
Operate and maintain analytical instruments including LC-MS/MS, HPLC, GC-MS, and immunoassay platforms.
Perform system suitability checks, calibration, and routine maintenance.
Ensure compliance with GLP/GMP and laboratory safety procedures.
Data Analysis & Documentation
Analyze and interpret bioanalytical data using software such as Analyst, Watson LIMS, or Phoenix WinNonlin.
Prepare technical reports, validation protocols, and study summaries.
Maintain proper documentation for regulatory audits and submissions.
Cross-functional Collaboration
Collaborate with pharmacokinetics, toxicology, clinical, and regulatory teams.
Support IND/NDA submissions and regulatory filings.
Communicate results and scientific findings to stakeholders.
Required Qualifications
MS or PhD in Bioanalytical Chemistry, Pharmaceutical Sciences, Biochemistry, or related field.
2–8+ years of experience in bioanalytical method development and sample analysis.
Strong experience with LC-MS/MS and ligand-binding assays.
Knowledge of GLP/GMP and regulatory guidelines.