Senior Research Associate 2, Bioanalytical Assays

Duties and Responsibilities

• Design, develop, optimize, and troubleshoot bioanalytical assays for quantification of drugs in biological matrices (e.g., plasma, serum).
• Perform method validation activities in accordance with regulatory guidelines (e.g., FDA, EMA), including accuracy, precision, selectivity, sensitivity, reproducibility, and stability assessments.
• Conduct PK analysis of clinical study samples while ensuring data integrity and compliance with GCLP standards.
• Maintain detailed and accurate laboratory notebook, including protocols, raw data, and reports.
• Analyze and interpret experimental data; and summarize results.
• Support preparation of study reports, validation reports, and regulatory documentation.
• Manage general laboratory operations, including ordering supplies and equipment maintenance.
• Other duties/responsibilities as assigned.

Requirements

• M.S. in a relevant field with 2-5 years of experience or a Bachelor's degree with 5+ years of experience in life sciences related field.
• Strong written and verbal communication skills. Writing skills include routine communications and technical reports detailing procedures, outcomes, and observations. Ability to effectively present information in one-on-one, small groups and lab meetings.
• Demonstrated proficiency using Microsoft Office applications (Word, Excel, PPT) as well as job related electronic systems/applications.
• Proficient in applying established mathematical and scientific techniques to compile and analyze data.
• Knowledge of laboratory techniques and protocol development, with adherence to Good Clinical Laboratory Practice (GCLP) standards.