Ardelyx
Associate Director, Stability
TLDR
Lead stability studies and manage cross-functional collaborations while contributing to regulatory filings and optimizing drug lifecycle outcomes.
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.
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.
Please note: this position is hybrid-based out of our Waltham, MA or Newark, CA office and requires a presence on-site 2-3 days per week.
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
Qualifications:
- 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 small molecule 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 small molecule 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
The anticipated annualized base pay range for this full-time position is $169,000-$207,000. Ardelyx utilizes industry data to ensure that our compensation is competitive and aligned with our industry peers. Actual base pay will be determined based on a variety of factors, including years of relevant experience, training, qualifications, and internal equity. The compensation package may also include an annual bonus target and equity awards, subject to eligibility and other requirements.
Ardelyx also offers a robust benefits package to employees, including a 401(k) plan with generous employer match, 12 weeks of paid parental leave, up to 12 weeks of living organ and bone marrow leave, equity incentive plans, health plans (medical, prescription drug, dental, and vision), life insurance and disability, flexible time off, annual Winter Holiday shut down, and at least 11 paid holidays.
Ardelyx is an equal opportunity employer.
Benefits
Comprehensive health plans
Health plans (medical, prescription drug, dental, and vision)
Paid Time Off
12 weeks of paid parental leave
Ardelyx is a biopharmaceutical company focused on developing and commercializing first-in-class medicines aimed at significant unmet medical needs. With products like IBSRELA® and XPHOZAH®, Ardelyx utilizes innovative solutions to address critical health issues such as IBS and hyperphosphatemia, both in the U.S. and through partnerships in international markets.
Associate Director