- Perform testing to qualify raw materials vendors and assist in establishing product
- Perform laboratory equipment calibration/verification and preventative maintenance.
- Provide analytical support to Product Development, QC, QA and Regulatory departments as
- Perform troubleshooting and investigations under the direction of management.
- Perform structure elucidation of unknown impurities/degradation products when necessary.
- Communicate material issues or testing delays to the appropriate internal customer(s) (i.e.,
- Peer review of data, reports and notebooks
- Develop and validate analytical test methods for assay, impurities/degradation products,
preservatives, leachable, residual solvents in drug products according to ICH/FDA/USP
- Analyze test results, draft validation reports and make technical recommendations.
Introduce and evaluate new technologies/instrumentation and assist the department head with
the introduction of new technologies and instrumentation.
- Bachelor’s degree in Microbiology and 4 – 5 years of laboratory experience or a master’s degree
in Microbiology and 2 – 3 years of experience, preferably within a pharmaceutical or
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