What are the responsibilities and job description for the Associate Scientist – Stability (Quality) position at Planet Pharma?
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.
Key Responsibilities
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.
Key Responsibilities
- 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