DUTIES – RESPONSIBILITIES:
• Develop and validate the analytical methods for the release and stability testing of clinical-grade and commercial-grade radiopharmaceuticals.
• Perform QC release and stability testing (e.g., pH, HPLC, GC, sterility, bacterial endotoxin test, bioburden, etc.) of radiopharmaceuticals for clinical and commercial use according to cGMP standards.
• Perform release testing according to SOPs on other materials (e.g. raw materials for radiopharmaceutical production).
• Generate and maintain accurate testing records and test/validation results.
• Bachelor’s degree in a scientific related discipline (e.g. Chemistry, microbiology)
Technical Skills Required:
• 3+ year experience in a commercial pharmaceutical development or manufacturing analytical laboratory
• Knowledge of GMP/GLP principles
• Knowledge of safety procedures for hazardous environment (chemical and radioactive)
• Knowledge of cGMP laboratory controls and analytical method development and validation
• Knowledge of Current Good Manufacturing Practice (21 CFR 211)
• Knowledge and experience with quality assurance oversight of aseptic manufacturing processes
• Knowledge and experience with pharmaceutical quality systems and quality assurance concepts
• Radiopharmaceutical experience a plus.
• Excellent communication skills both verbal and written.
• Strong problem- solving skills.
• Effective interpersonal skills.
• Must be able to manage multiple priorities.