My client is expanding and seeks a Stability Scientist to take on the following tasks:
- Oversee the operations of the stability program through data analysis and approval of protocols and reports.
- Manage CMOs and ensure that studies conducted externally are executed compliantly and on time.
- Ensure completion of stability-related deviations, CAPAs, and Change Controls by providing technical oversight.
- Generate, update, and retire stability-related SOPs.
- Ensure that the stability-related forms and documents adhere to GXP requirements and internal SOPs.
- Represent QC Stability on cross functional teams.
The ideal candidate will possess the following qualities:
- BS degree and 8+ years of relevant experience in a GxP environment with at least 3 years of Stability experience in a GMP regulated environment.
- Experience with analytical methods and stability of biologics, as well as writing SOPs, investigations, stability protocols and reports.
- Experience working with LIMS and statistical software and interfacing with CMOs/CTLs.
- Exceptional organizational and time management skills coupled with strong communication skills.