Scientist II, Biopharmaceuticals (GMP)
Core
Perform routine to complex sample preparation and analysis of pharmaceutical and biopharmaceutical compounds in formulations and biological matrices for stability and analytical testing within a GMP laboratory.
Role type
Scientist II, Biopharmaceuticals (GMP)
Builds
Analytical data and quality records for drug development
Domain
Biopharmaceuticals / Analytical Chemistry
Required skills
Analytical instrumentation operation and maintenance, Sample preparation, Regulatory compliance (GMP/GLP/ICH), Troubleshooting, Quality control management, Documentation (SOPs), Manual dexterity
Preferred skills
Cross-training on sample preparation techniques, Project management
Technologies
Analytical instrumentation, Office equipment
Responsibilities
Train on routine operation, maintenance, and theory of analytical instrumentation, SOPs, and regulatory procedures; Perform sample preparation and analysis to quantitatively measure compounds; Complete laboratory documentation according to SOP and GLPs; Independently troubleshoot equipment & instruments; Review and comply results from assignments; Independently manage QC responsibilities; Author low complexity quality records and participate in OOS/OOT/Atypical investigation process.
Seniority
Mid-level, hands-on IC
