Evaluates critical pharmaceutical quality attributes and their relevance to safety and efficacy and ensures consistency in new drugs quality assessments/chemistry reviews.
Ensures new drug product quality in line with quality-by-design (QbD) principles for New Drug Applications (NDAs), Investigational New Drug Applications (INDs) amendments and supplements.
Assesses the pharmaceutical quality of new drug IND and NDA submissions by conducting critical quality reviews and identifying, communicating, and resolving approvability issues for IND and NDA assigned to the Division.
Evaluates and formulates decisions or recommendations regarding approvability in accordance with applicable delegation of authority on the suitability of manufacturing methods and controls, drug products designs, and related facilities proposed by IND sponsors and NDA applicants.
Evaluates and assesses chemistry, manufacturing, and controls (CMC) specifications based on: risk-based assessments; clinical relevance (performance and safety considerations); process knowledge and understanding; and utilization of modern statistical methodologies.
Performs the initial screening, or triaging, of supplements and determines if/what type of ONDQA resources are needed to complete the quality review of supplements.
Assesses annual reports and evaluates the post-making reporting system.
Provides scientific expertise with an understanding of manufacturing processes and controls, as well as updated knowledge and skills in pharmaceutical dosage forms, process analytical techniques, and industrial pharmacy.