What are the responsibilities and job description for the QC Chemist position at AR Val Services?
Job Details
At least 5 years of experience
Biologics/large molecule background (monoclonal antibodies)
HPLC, protein A HPLC
Size exclusion chromatography
Peptide mapping
N-glycan (analytical chemistry method)
Essential Functions of the job:
- Lead and execute QC chemistry assay validation and transfer activities, including testing (e.g., DS, DP release and stability testing) to ensure timely generation and reporting of test results in support of manufacturing operations.
- Support routine operations, including but not limited to leading instrument qualification and maintenance, SOP generation and revision, specification generation and revision, testing record keeping, etc.
- Manage inventory of reagents and supplies for the laboratory.
- Lead laboratory investigations, including but not limited to OOS, Out of Trend, deviations, invalid assays, and associated corrective actions.
- Lead method transfer and method validation activities, including protocol preparation, protocol execution, and report preparation. Working knowledge and experience in an FDA-regulated biotechnology, pharmaceutical company are required.
- Working knowledge and hands-on experience with Chemistry analytical methods for biological products (monoclonal antibodies), such as HPLC, UPLC, Container Closure Integrity (CCIT), Sub-visible Particles, N-glycan, UV spectrophotometer, including qualification, assay validation and transfer activities
- Knowledge with USP/EP and cGMP/EU GMP, and ICH guidelines.
- Lead instrument and equipment validation
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