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Extractables & Leachables Study Director

American Preclinical Services

This is a Full-time position in Minneapolis, MN posted July 17, 2021.

Position Type Full Time

4 Year Degree

Job Shift Day

Job Category Research

Provides scientific support and leadership to clients and other scientific staff in the conduct of extractables and leachable studies, including study design development, managing the execution of study conduct, collecting, analyzing and interpreting data, utilization of technology, and study report writing.

Bachelors degree or equivalent in Chemistry or related discipline required.

Two-three years experience in operating and interpreting mass spectrometry data (GCMS and/or LCMS) At least one year of experience in a study director role in a regulated environment.

Strong working knowledge of industry regulations (ISO 10993:12, 17, 18, ICH M7, ICH Q3D, USP , ISO/TS 21726, and ISO 17025) and preclinical testing facility operations and procedures.

Excellent technical writing and computer software skills.

Must be able to clearly speak, write, read, and understand English

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