Scientist II, Biopharmaceuticals (CE, HPLC)
Core
Perform routine to complex sample preparation and analysis of pharmaceutical and biopharmaceutical compounds in formulations and biological matrices for stability and analytical testing in a GMP laboratory.
Role type
Senior IC analytical scientist (QC)
Builds
Stability and analytical test data for drug development
Domain
Biopharmaceuticals / Analytical Chemistry
Required skills
Analytical instrumentation operation and maintenance, Sample preparation, GMP/GLP compliance, Regulatory guidelines knowledge (ICH, compendia), Troubleshooting, QA record authoring, OOS/OOT investigation
Preferred skills
Cross-training on sample preparation techniques, Mentoring others in troubleshooting
Technologies
HPLC, CE, Analytical instrumentation
Responsibilities
Perform sample preparation and analysis to quantitatively measure compounds, Complete laboratory documentation per SOP and GLPs, Independently troubleshoot equipment and instruments, Review and comply results per acceptance criteria, Manage QC responsibilities and communicate project status, Author low complexity quality records and participate in OOS/OOT investigations
Seniority
Mid-level, hands-on IC
