Research Associate II ~ Bioanalytical/In Vitro ADME/DMPK

Responsibilities

• Provide bioanalytical support for in-house PK, non-GLP safety TK
• Conduct bioanalytical method development and qualification to support drug, metabolite and biomarker analysis
• Independently develop LC-MS/MS methods to quantitate small molecules in in vitro and in vivo samples
• Conduct in-vitro stability assays to understand metabolism of drugs
• Perform metabolic identification (MetID) using LC-QTOF MS/MS, including accurate mass analysis, fragment interpretation and biotransformation pathway assignment
• Independently operate, troubleshoot and maintain LC-MS/MS systems
• Participate in multidisciplinary project teams and collaborate with other departments to understand bioanalytical needs for both PK and PD support
• Manage projects conducted at CROs to ensure high quality bioanalytical data is delivered to meet project timelines
• Maintain accurate and detailed scientific electronic laboratory notebooks

Requirements

• Provide sample analysis to support PK, PK/PD, PK/efficacy, distribution, metabolism, and non-GLP toxicology studies
• Identify issues and troubleshoot scientific equipment including LC-MS/MS, select and develop appropriate methods to perform experiments, analyze data and prepare related reports
• Excellent oral and written communication skills

Preferred Qualifications & Experience

• Experience with H/UPLC and mass spectrometry
• Good working knowledge of SCIEX LC-MS/MS systems for small molecule quantitation
• PK analysis using Phoenix or other data management software
• Management experience with CROs for outsourcing BA activities is preferred
• Broad experience in small molecule drug candidate bioanalytical assay development/sample analysis in different biological matrices using LC-MS/MS
• Experience with AB SCIEX mass spectrometry software
• Excellent written, verbal communications and interpersonal skills to collaborate with internal and external partners in a matrix environment