Associate Scientist Immunoassay

• Perform and document all procedures, materials and results in compliance with applicable regulatory standards as applicable (protocols, methods, SOPs, etc.)

• Embody the behaviors and performance characteristics as described in our core values

• Develop knowledge of regulatory requirements (GLP, GCP, GMP, EPA, OECD, CLIA, 21CFR Part 11) and apply as required by operational area

• Develops effective communication skills through both informal and formal discussions with peers, supervisor, internal teams, and externally with Regulators

• Develop critical thinking, troubleshooting and time management skills aligned with the needs of the operational area

• Ensures that operational area is clean and inspection ready at all times

• Accurately prepare reagents with oversight

• Accurately perform laboratory support functions such as labeling, monitoring expiration dates, waste removal and solution preparation with oversight

• Operate and maintain analytical instruments with minimal oversight as required by operational area

• Effectively assist in the execution of routine sample analysis studies with oversight

• Perform data analysis in appropriate software for at least one analytical platform with oversight

• Accurately write both study and non-study deviations with oversight

• BA/BS or higher

• Able to perform basic 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.