Department: Quality Control
Job Title: Quality Control Analyst II/III (Chemistry)
Description:
The Quality Control Analyst II/III will provide support to GMP manufacturing of multiple clinical programs through performance of general to complex release and stability testing for drug substance and drug product. Expected contributions to general laboratory operations, documentation practices, and quality system improvements and implementation. Demonstrate technical and troubleshooting experience in chromatography. Ability to lead laboratory initiatives, contribute input, and achieve group objectives. This position requires flexibility with changing priorities.
Key responsibilities and tasks include, but are not limited to:
Performance of QC analytical testing (e.g. HPLC, CE, electrophoresis, quality assays) on drug substance and drug product for release and stability across multiple programs.
Support operational systems (e.g. equipment maintenance, reagent preparation, forms control, etc.
Participate in method transfers to/from other ImmunoGen, contract, or partner sites.
Assist in the authorship of, and support execution of, method qualifications with minimal guidance.
Authors SOPs, deviations, OOS’, and investigations with minimal guidance.
Train on all relevant procedures and provide training to group members, as appropriate.
Troubleshoot routine problems related to laboratory procedures, assay performance, instrumentation, and data with minimal input from Supervisor; provide recommendations to non-routine issues.
Collaborate with other internal departments efficiently and effectively (e.g. Analytical and Pharmaceutical Sciences, Manufacturing, QA, etc.); may participate in team meetings with partners and/or contractors.
Assist in the installation and qualifications of instruments.
Job Requirements:
Minimum education required for this position is an Associates Degree in a scientific discipline (e.g. Analytical Chemistry, Biochemistry, Chemistry, Biology, etc.).
Minimum experience required for this position is 3 – 4 years of relative experience in a GMP laboratory. Must demonstrate competency with laboratory skills, including documentation.
Other requirements include good organizational skills, communication skills (i.e. verbal and written) and good technical skills (including computer-related).
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