Senior Director, Process Chemistry

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 Senior Director, Process Chemistry will be responsible for leading small-molecule process development and manufacturing efforts for clinical-stage and commercial Drug Substances.Responsibilities:

• Lead all Drug Substance (DS) efforts, including process development as well as the manufacture of DS for clinical and commercial purposes
• Develop outsourcing strategies and relationships to support all aspects of DS development and manufacturing
• Develop and lead the successful execution of phase-appropriate DS project plans; prepare RFPs and assist in selecting vendors
• Lead the preparation of the DS sections of various regulatory documents (IND, NDA, etc.)
• Effectively integrate DS activities with those of sister CMC functions, including Pharmaceutics, Analytical Development, Quality Assurance, and Regulatory Affairs
• Supervise internal and external technical staff as needed to ensure effective execution of activities and attainment of goals
• Integrate DS activities with those of other corporate functions, including legal, finance, and HR
• Effectively and professionally represent the Process Chemistry function, and when needed the broader CMC function, on various cross-functional teams including internal project teams as well as external steering and operating teams with contract manufacturing and/or corporate partners 

Qualifications:

• Ph.D. in organic chemistry, chemical engineering, or related discipline with 12 - 15 years of industry experience or equivalent experience
• Strong experience required in small molecule process development
• Experience supporting DS for different drug product types is desirable
• Experience working in close collaboration with technical, regulatory, quality, clinical, project management, and supply chain functions, in a cGMP operational environment
• Experience in leading and managing outsourced development and manufacturing efforts and associated operating budgets
• Experience in preparing and defending regulatory documents including briefing books for regulatory meetings, INDs, and NDAs
• Demonstrated track record of setting priorities, meeting timelines, motivating others, and managing budgets
• Superb communication skills and the ability to shape, frame, and present to diverse internal and external audiences are required
• Periodic travel to manufacturing and other partner sites is required (approximately 10-20 % of time).

The anticipated annualized base pay range for this full-time position is $243,000-$297,000. 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.