Associate Director, Stability

Ardelyx is a publicly traded commercial biopharmaceutical company founded with a mission to discover, develop and commercialize innovative first-in-class medicines that meet significant unmet medical needs. The Associate Director, Stability is a self-motivated individual who works as a member of an integrated team at Ardelyx contracting, designing, managing, and evaluating stability studies at contractors for both drug substance and drug product.

Requirements

• B.S. degree in a scientific field, such as chemistry or biology
• 10+ years' experience working in the pharmaceutical industry or equivalent experience
• Excellent working knowledge of analytical chemistry
• Flexible and adaptive team player with excellent verbal and written communication skills
• Exceptional organizational skills and meticulous attention to detail
• Extensive experience with drug product and drug substance stability programs
• Experience managing contractor stability activities
• Extensive experience with ICH and FDA guidelines
• Experience in authoring regulatory submissions (IND, NDA, MAA) and associated reports