Associate Director, Process Chemistry

Ardelyx • Waltham, MA

23h • $183,000 - $223,000 • Hybrid

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, Process Chemistry will lead small-molecule process development and manufacturing efforts supporting clinical-stage drug substance programs, with a primary focus on early-phase clinical manufacturing. This role spearheads the design, development and technical oversight of synthetic routes for programs ranging from IND-enabling studies through Phase 2, ensuring that Drug Substance supply is delivered with speed, quality, and phase-appropriate controls. The Associate Director will work closely with cross-functional teams across CMC, analytical development, quality, regulatory, and manufacturing to advance development programs and support clinical timelines.

Requirements

• Ph.D. in organic chemistry or related discipline with 8+ years of pharmaceutical industry experience with a strong emphasis on small-molecule process development
• Proven track record in developing scalable, safe, and efficient synthetic processes within a cGMP operational environment
• Demonstrated experience working in close collaboration with technical, regulatory, quality, clinical, project management, and supply chain functions, in a cGMP operational environment
• Experience leading and managing outsourced development and manufacturing efforts and associated operating budgets
• Experience preparing and defending regulatory documents including briefing books for regulatory meetings
• Demonstrated track record of setting priorities, meeting timelines and motivating others
• Excellent 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)

Responsibilities

• Partner with cross-functional teams to provide technical oversight of early phase Drug Substance (DS) process development, ensuring successful scale-up and manufacture of clinical trial materials
• Provide evaluation and support the identification and selection of "fit-for-purpose" synthetic routes, balancing speed to clinic with long-term scalability, safety, and manufacturability
• Develop, manage, and drive the successful execution of phase-appropriate DS project plans, including the preparation of RFPs and the technical evaluation of potential vendors
• Support the preparation of the DS sections of various regulatory and contribute to technical briefing materials for regulatory agency interactions
• Effectively integrate DS activities with those of sister CMC functions, including Pharmaceutics (to support formulation screening), Analytical Development, Quality Assurance, and Regulatory Affairs
• Direct external technical staff at contract manufacturing organizations (CMOs) to ensure effective execution of activities and attainment of clinical supply goals
• Effectively and professionally represent the Process Chemistry function on various cross-functional teams, including internal project teams and external operating teams with contract manufacturing and/or corporate partners

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Ph.D. or professional degree
• Number of Employees: 101-250 employees