Scientist I Immunoassay

• Develop, validate, and troubleshoot bioanalytical methods for sample testing and data reporting, serving as the Principal Investigator (PI) as required.
• Present and interpret data both internally and externally, ensuring clarity and scientific rigor.
• Maintain client satisfaction through timely communication, responsiveness, and on-schedule delivery of high-quality results.
• Prepare and review laboratory data and controlled documents, including study plans and final reports.
• Support laboratory operations and provide mentorship to junior staff members.
• Contribute to the development and refinement of policies, procedures, work instructions, and standard operating procedures (SOPs).
• Ensure compliance with company standards, including Code of Conduct, Environmental Health and Safety (EHS), and GLP/GCP/GDP regulations.
• Perform additional duties as assigned to support team and organizational goals.
• BA/BS or higher with 7-8 years lab experience; all experiences will be evaluated
• Knowledge and understanding of regulatory requirements; GLP, GCP, 21CFR Part 11, GDP, GMP
• Able to independently perform complex lab work
• Able to work in a regulated environment
• Able to work effectively and contribute within a team
• Able to work with computer systems
• Able to document clearly

Performs and leads complex lab work, sample analysis, validation, and method development with limited supervision.