Ardelyx, Inc. · 1 day ago
Associate Director, Stability
Waltham, MA
Full-time
Onsite
Lead/Staff, Director/Executive
10+ years expArdelyx, Inc. is a publicly traded commercial biopharmaceutical company focused on developing innovative medicines. The Associate Director, Stability will manage and evaluate stability studies for drug substances and products, ensuring compliance with regulatory guidelines and corporate objectives.
BiotechnologyHealthcareHealth CareMedical
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
Qualification
Required
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
Company
Ardelyx, Inc.
Ardelyx was founded with a mission to discover, develop and commercialize innovative, first-in-class medicines that meet significant unmet medical needs.
201-500 employees
Funding
Current Stage
Public CompanyTotal Funding
$557.68MKey Investors
HealthCare Royalty PartnersSLR Capital PartnersNew Enterprise Associates
2022-06-30Post Ipo Debt· $20M
2022-02-24Post Ipo Debt· $27.5M
2019-12-12Post Ipo Equity· $125M
Leadership Team
Mike Raab
President & CEO
Elizabeth Grammer
Chief Legal and Administrative Officer
Recent News
GlobeNewswire
2026-01-23
2026-01-20
2026-01-20
Company data provided by crunchbase