Responsible for cGMP QC release and stability testing of biopharmaceutical drug products, drug substances and process intermediates using HPLC. Authors and reviews protocols and executes testing to support analytical method validation and technical transfer of HPLC methods. Participates on cross-functional project teams as a subject matter expert
Works in a cGMP QC laboratory setting, responsible for routine and non-routine HPLC assays on drug product and drug substance. Ensures timely delivery of test results to meet deadlines for delivery of accurate, verified release and stability data. Coordinates with external vendors for sample testing as needed.
Performs timely and accurate review of laboratory data, proactively identifies and reports trends or suspect results, thoroughly investigates and documents laboratory events and investigation
Provides subject matter expertise regarding the current methodology and analysis by HPLC. Develops, maintains, and revises relevant QC SOPs, prepares and presents technical data to management, effectively trains and mentors laboratory staff.
Ensures that laboratory equipment is qualified. Schedules and/or performs preventative maintenance and/or calibration activities. Maintains and appropriately documents use of equipment within the QC laboratory and ensures a state of inspection readiness.
Identify and lead continuous improvement initiatives through effective use of change management.
Must have the ability to function with limited supervision. Extensive knowledge of and proficiency with current HPLC methodology (SE-HPLC, IEC, RP-HPLC, affinity chromatography) and associated Waters instrumentation. Knowledge of capillary electrophoresis methodology a plus.
Familiarity with stability testing of biopharmaceutical products, information management, investigations, method validation, method transfer, instrument qualification, corrective actions / preventive actions management, and creation of protocols and reports.
Effectively participates in validation and technical transfer of analytical methods in compliance with FDA and ICH guidelines. Authors, reviews and approves analytical methods, validation protocols and technical reports