Durham, North Carolina4 days ago
Activities include, but not limited to: method development, method establishment, method qualification, method validation, bridging method qualifications, method transfers, compendial method verification, reference material characterization, non-GMP Drug Substance release and stability, non-GMP Drug Product release and stability, reference material release and stability, GMP Bulk Drug Substance release and stability, GMP Drug Product release and stability, Placebo release and stability, IVSS release and stability, clinical in-use studies, preformulation studies, formulation studies, identity testing, and various ad-hoc stand alone tests. Provide technical support for testing, including method establishment, method qualification, method validation, bridging method qualifications, method transfers, compendial method verification, reference material characterization, non-GMP Drug Substance release and stability, non-GMP Drug Product release and stability, reference material release and stability, GMP Bulk Drug Substance release and stability, GMP Drug Product release and stability, Placebo release and stability, IVSS release and stability, clinical in-use studies, preformulation studies, formulation studies, identity testing, and various ad-hoc stand alone tests.