Scientist I Immunoassay

Responsibilities

• 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.

Skills, Education & Qualifications

• 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

• Knowledge of and experience in a regulatory environment