Lead stability initiatives for medical devices, pharmaceuticals, and cosmetic products by designing, executing, and evaluating critical stability studies. This role plays a central part in defining shelf life and storage conditions, directly influencing product labeling and market readiness.
Key Responsibilities
- Design and manage stability programs to support product claims, working with technical experts to define testing methods and acceptance thresholds.
- Collaborate with product development teams to integrate stability requirements early in the design process.
- Develop, review, and maintain stability protocols and final reports, ensuring scientific rigor and regulatory alignment.
- Analyze and interpret stability data, identifying trends and supporting technical justifications for expiration dating.
- Ensure all data collection and documentation practices meet FDA, CE, and ISO regulatory standards.
- Support audits, investigations, and corrective actions related to deviations, CAPA, and out-of-specification results.
- Contribute to continuous improvement initiatives across stability testing processes and documentation systems.
Qualifications
Candidates must hold a Bachelor of Science in Chemistry, Biology, or a related scientific discipline, with a minimum of two years’ experience in the medical device or pharmaceutical industry. Demonstrated understanding of FDA regulations, including 510(k), ANDA, and NDA pathways, is essential, along with familiarity with CE technical documentation.
Proficiency in root cause analysis and risk assessment is required, as is the ability to work independently with strong attention to detail. Experience with ISO 11607, stability-indicating test methods, LIMS, and protocol management is preferred. The role may involve up to 10% travel for business-related activities.
