Associate Director, Quality Control Stability Program Management

Location
Brisbane, CA
Posted
Jan 27, 2021
Required Education
Bachelors Degree
Position Type
Full time

Position:        Associate Director, Quality Control Stability Program Management

Reports to:     Executive Director, Quality Control

Location:        Brisbane, CA  

Summary

The Quality Control candidate will be a part of the Analytical Development and Quality Control Team with a key focus on supporting commercial and clinical drug substance and drug product activities for all Aimmune products. The candidate will lead and coordinate all QC related activities associated with the management of the Aimmune stability program.  Additionally, the candidate will also support the analysis, review, and trending of release and stability data, support new and on-going stability programs, regulatory filings (IND, BLA and MAA), author SOPs, and participate in investigations and raw data audits from CTLs.  Prior experience with commercial quality control release/stability testing/manufacturing development of pharmaceutical products is required. The candidate must have extensive knowledge of FDA, ICH and EU stability regulatory requirements.  The individual should have the ability to work effectively in a virtual analytical development, quality control, and manufacturing environment.