Bristol-Myers Squibb Company

Stability Scientist

Location
New Brunswick, NJ, US
Posted
Oct 09, 2018
Ref
R1510559
Required Education
Bachelors Degree
Position Type
Full time
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.

Key activities:
  • 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.