Topic: process development

Lead global chemistry, manufacturing and controls regulatory strategy for small-molecule and monoclonal-antibody medicines. The role oversees investigational and marketing submissions, manufacturing-change assessments and health-authority interactions, working with process development, analytical development and quality teams from early development through commercialisation.

Support the scientific qualification and testing of raw materials used in therapeutic manufacturing at Beam’s Durham site. Responsibilities include material specifications, risk assessments, sampling, laboratory testing, interpretation of compendial methods and review of external testing. The analyst also investigates unexpected results and works with process development and manufacturing colleagues to resolve material quality issues.