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Senior Research Associate 2, Bioanalytical Assays

SAB

Sioux Falls, SD

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JOB DETAILS
JOB TYPE
Full-time
SKILLS
Analysis Skills, Assay Development, Assays, Biology, Clinical Assessment, Clinical Data, Clinical Practices/Protocols, Clinical Support, Clinical Trial, Clinical Validation, Communication Skills, Data Analysis, Data Collection, Data Quality, Develop Methodologies, Documentation, Drug Development, Equipment Maintenance/Repair, FDA (Food and Drug Administration), GCP (Good Clinical Practices), GLP (Good Laboratory Practices), Identify Issues, Immunoassays, Laboratory Management, Laboratory Notebook, Laboratory Operations, Laboratory Techniques, Ligand Binding, Mathematics, Microsoft Excel, Microsoft Office, Microsoft Word, Operations Management, Order Supplies, Pharmacokinetics, Physical Demands, Plasma, Presentation/Verbal Skills, Regulations, Regulatory Compliance, Regulatory Reports, Regulatory Submissions, Stability Analysis, Writing Skills
LOCATION
Sioux Falls, SD
POSTED
30+ days ago
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.
Education/Experience/Skills:
  • 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.
Physical Demands:   
While performing the duties of this job, the employee is regularly required to walk, stand and sit. The employee will be able to use the pipettes for long periods at any given time. The employee must regularly  lift and/or move up to 10 pounds. Specific vision abilities required by this job include close vision, peripheral vision, and the ability to adjust focus.

Working Environment and Travel:
Normal laboratory working conditions. 
Business travel is not typical for this position.

ADA: 
The employer will make reasonable accommodations in compliance with the Americans with Disabilities Act of 1990.

SAB BIO is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. SAB BIO is committed to the principle of equal employment opportunity for all employees and does not discriminate based on race, religion, color, sex, gender identify, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other legally protected status. EOE/AA/Vets

 

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