Research Associate II, stability
Core
Develop stability study designs, execute technical tasks, and provide expert advice on regulatory compliance for product development and sustaining projects.
Role type
Senior IC pharmaceutical stability scientist
Builds
Stability study designs and regulatory submissions for new and sustaining pharmaceutical products
Domain
Pharmaceutical industry + stability testing
Required skills
stability study design, regulatory compliance (ICH guidelines), technical problem solving, experimental design, project management, cross-functional collaboration, process improvement
Preferred skills
advanced analytical techniques, innovation in stability methods, stakeholder coordination
Technologies
electronic stability protocols, regulatory submission systems
Responsibilities
Develop stability study designs for new and sustaining product projects; independently execute routine and non-routine stability tasks; provide technical rationale for expiration dating and storage conditions; prepare regulatory submissions; ensure compliance with ICH guidelines; lead analytical problem-solving efforts; coordinate with cross-functional teams.
Seniority
Senior, hands-on IC
