Senior Director, Process Chemistry

Ardelyx • Waltham, MA

106d • $243,000 - $297,000

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.

Requirements

• 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

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

Benefits

• 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
• At least 11 paid holidays

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Chemical Manufacturing
• Education Level: Ph.D. or professional degree