Associate Scientist – Stability; Quality

Position Summary

We are seeking a detail‑oriented and motivated Associate Scientist to support analytical stability studies within a cGMP‑regulated environment. This role focuses on executing stability programs, managing samples, and ensuring data integrity and regulatory compliance.

• Perform stability testing using analytical techniques such as:
  • HPLC
  • GC
  • Karl Fischer (KF)
  • Other physicochemical methods
• Support stability study execution in compliance with ICH, FDA, and regulatory guidelines
• Coordinate sample management
  , including stability chambers and inventory tracking
• Generate, review, and maintain:
  • Stability protocols
  • Analytical data
  • Study reports
• Conduct OOS (Out-of-Specification) investigations and support CAPA activities
• Ensure all laboratory work complies with cGMP standards
• Collaborate with cross‑functional teams and clients to support product quality initiatives

• Education: Bachelor’s degree in Chemistry or related scientific field
• Experience:
  • ~2+ years in an analytical or quality lab (cGMP environment preferred)
  • Experience with HPLC and standard lab instrumentation
• Preferred:
  • Stability or QC lab experience
  • Familiarity with ICH stability guidelines
  • Experience with OOS investigations

• Strong analytical and problem-solving abilities
• Hands‑on lab skills (sample prep, assays, impurity testing)
• Ability to manage multiple priorities in a fast‑paced environment
• Strong communication and teamwork skills