Senior Medical Laboratory Scientist

Role Summary

The Senior Medical Laboratory Scientist will engage in independent analysis of samples, review quality control processes, piloting new procedures, equipment validation, and writing standard operating procedures. The Senior Medical Laboratory Scientist will stay up to date with industry standards and provide scientific guidance to Study Directors and Sponsors.

Role Responsibilities

• Determine the acceptability of samples for testing according to established criteria.
• Advanced sample processing for blood, urine, cerebrospinal fluid, and other specimens in accordance with SOPs and/or Sponsor requirements.
• Monitor and operate instrumentation, including chemistry, hematology, coagulation, and urine analyzers.
• Notify vet staff of clinically significant results.
• Review of preventative maintenance and quality control data.
• Study protocol review.
• Collect and record data both on paper and electronically in a laboratory management system in accordance with Good Laboratory Practices (GLP).
• Data review for GLP compliance.
• Run, submit, and critically review instrument linearity, precision, and advanced calibrations.
• Prepare, test, and evaluate new reagents, controls, and calibrators.
• Perform existing and new equipment qualification and review.
• Advanced microbiological sample processing, testing, and analysis of samples.
• Identify and initiate process improvement initiatives for medical laboratory procedures and processes.
• Coordinate sample workflow with internal and external personnel.
• Train and mentor Medical Laboratory Scientists and Clinical Pathology Technicians
• Independently write standard operating procedures
• Independently write and run validation scripts.
• Pilot new procedures.
• Communicate directly with Study Directors and Sponsors to provide scientific guidance for protocols based on clinical pathology standards.
• Stay up to date with industry standards.
• Other duties as assigned.

Role Requirements

• BA/BS in relevant discipline required.
• Minimum 5 years of medical laboratory experience required.
• ASCP or AMT certification required.
• Excellent written and oral communication.
• Advanced understanding of study design and operational procedures in a pre-clinical environment.
• Advanced knowledge of GLP and other federal regulations relating to the care of laboratory animals.
• Exhibit strong self-initiative.
• Ability to identify and resolve complex issues.

Behavioral Expectations

• Self-initiative
• Critical Thinking
• Communication

Special Requirements

• This role works predominantly in a laboratory. There will be exposure to human and animal pathogens and chemicals. There will be handling of and/or exposure to animal tissues and zoonotic organisms.
• Ability to don and wear personal protective gear, including N95 masks and respirators.
• Physical requirements: Ability to lift and carry up to 50lbs.
• Ability to work beyond typical work schedule including evenings, weekends, and extended shifts with short notice.