- Santa Monica, California, United States
- On-site
- Full-time · Senior
- $101K–$151K per year
- 3–7 years
The successful candidate will contribute to the advancement of our product pipeline by supporting all stability testing across multiple products and sites. This individual is a subject matter expert responsible for coordinating stability testing, facilitating stability execution, authoring stability report, managing EDAs, and leading all investigations related to stability.
Compensation
The annual base pay (or hourly rate of compensation) for this position ranges from $100,786 to $151,179. Our positions offer eligibility for various incentives—an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles.
Responsibilities
- Author, review and execute Protocols and relating to Drug Product and Drug substance stability
- Serve as Quality Stability Subject Matter Expert (SME) during health authority inspections, client audits, and internal reviews
- Author stability protocols, summary reports, and regulatory submission documents
- Assess stability data, perform statistical analyses (e.g., using Prism or JMP), and evaluate trends to determine product shelf-life and retest periods
- Lead investigations for Out-of-Specification (OOS), Out-of-Trend (OOT), atypical results, and stability-related deviations or CAPAs
Requirements
- PhD degree preferably in a related science field
- Master’s degree preferably in a related science field
- Bachelor’s preferably in a related science field
- Associate’s degree preferably in a related science field
