Associate Director, Stability

Ardelyx • Waltham, MA

2d

About The Position

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. Ardelyx has two commercial products approved in the United States, IBSRELA® (tenapanor) and XPHOZAH® (tenapanor). Ardelyx has agreements for the development and commercialization of tenapanor outside of the U.S. Kyowa Kirin commercializes PHOZEVEL® (tenapanor) for hyperphosphatemia in Japan. A New Drug Application for tenapanor for hyperphosphatemia has been approved in China with Fosun Pharma. Knight Therapeutics commercializes IBSRELA in Canada.
Position Summary:
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. This individual should have the breadth of experience required to manage stability studies in early stage as well as in commercial stage. This individual should have a good knowledge of ICH and cGMP guidelines and the ability to contribute to regulatory filings as needed for stability.

Requirements

• B.S. degree in a scientific field, such as chemistry or biology, with 10+ years’ experience working in the pharmaceutical industry or equivalent experience
• Excellent working knowledge of analytical chemistry with prior experience as an analytical scientist desirable
• 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
• Ability to travel up to 5% domestically or internationally

Responsibilities

• Develop and implement the strategic direction of stability programs aligned with corporate goals and product life-cycle objectives
• Oversee the design, execution, and management of stability studies (development, registration, and commercial)
• Work cross functionally with CMC, supply chain, quality, regulatory, clinical and related teams to achieve stability objectives
• Contract with and manage manufacturing and analytical contractors conducting stability studies including supporting finance in forecasting and expense tracking
• Coordinate and facilitate the movement of material to stability contractors from manufacturing sites as needed
• Initiate and drive stability protocol generation and other quality documents in support of stability studies
• Compile stability study results, perform trend and statistical analyses, and prepare reports to support retest/shelf-life date extensions and storage condition recommendations
• Partner with quality during stability quality events (QEs) or investigations and implementation of CAPAs at contractors
• Author CMC stability documentation for IND, NDA and IMPD filings, covering all phases of clinical development and commercial activities
• Represent the stability function and present work at intra/inter departmental meetings

What This Job Offers

• Job Type: Full-time
• Career Level: Director