Senior Research Associate 2, Clinical Bioanalysis

SAB • Sioux Falls, SD

6d

About The Position

The Senior Research Associate 2, CB is responsible for executing experiments, immunoassays, and technical procedures. Working under the supervision of the Manager, this role supports clinical pharmacokinetic (PK) assay development, validation, and clinical sample analysis in compliance with regulatory guidelines. This position plays a critical role in generating high-quality bioanalytical data to support clinical trials, regulatory submissions, and drug development programs. The ideal candidate possesses strong knowledge of, and hands-on experience with, ligand-binding assays and flow cytometry platforms within a regulated (GCLP) environment.

Requirements

• M.S. in a relevant field with 2-5 years of experience or a Bachelor's degree with 8+ 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.

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 electro 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 11-50 employees