Responsible for providing stability support for small molecule, non-sterile drug products manufactured at North America (NA) Manufacturing Sites, including overseeing all activities related to stability, maintaining expertise on stability standards, drug product performance, and stability program administration.
- Participates on transfer team for new products to the sites, reviews registrational stability studies and conducts gap analysis against Global Manufacturing & Supply requirements. Develops stability data where gaps exist.
- Develops and maintains expertise on the overall stability performance of products manufactured at NA sites, including maintaining a working knowledge of the attributes that impact the products' performance/stability profile.
- Serves as stability representative on project teams covering post-approval changes, designs and executes required premarket stability program in support of the change.
- Identifies batches meeting defined requirements for the marketed product stability program and other commitments for placement into the stability program.
- Authors stability sections of CTD dossiers for post-approval filings, annual reports, product renewals, Annual Product Stability Reviews, and stability related responses to health authority inquiries.
- Serves as stability representative for OOT/OOS investigations, Market Action Fact Finding, and other investigations related to potential quality issues and/or deviations from standards.