Senior Research Associate 2, Bioanalytical Assays
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Overview
Schedule
Full-time
Career level
Senior-level
Remote
On-site
Job Description
Some relocation assistance is available for this role.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.Duties and Responsibilities (Include but are not limited to):
- 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.
- 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.
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FAQs About Senior Research Associate 2, Bioanalytical Assays Jobs at SAB
What is the work location for this position at SAB?
This job at SAB is located in Sioux Falls, SD, according to the details provided by the employer. Some roles may also include multiple work locations depending on the requirement.
What pay range can candidates expect for this role at SAB?
Employer has not shared pay details for this role.
What employment applies to this position at SAB?
SAB lists this role as a Full-time position.
What experience level is required for this role at SAB?
SAB is looking for a candidate with "Senior-level" experience level.
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