Senior Director, CMC Operations

Ardelyx • Waltham, MA

9d • $250,000 - $306,000 • 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 Senior Director, CMC Operations, is responsible for leading and coordinating the company’s Chemistry, Manufacturing, and Controls (CMC) operational strategy across development and commercial readiness activities. This role ensures that CMC projects progress efficiently from early development through clinical and regulatory milestones by aligning internal teams, external partners, and technical strategy. Reporting to the Chief Technical Operations & Quality Officer, this role will serve as a central operational leader across Technical Operations, Regulatory, Quality, and Project Management to ensure manufacturing plans, timelines, and deliverables support the company’s broader development goals. This role requires a highly collaborative leader who is comfortable working in a fast-paced biotech environment and balancing strategic planning with hands-on execution.

Requirements

• Bachelor’s degree, advanced degree preferred, in Chemistry or related field
• 12+ years of experience in pharmaceutical or biotech industry, with at least 3 years in CMC project management or related technical operations role or equivalent experience
• Strong understanding of drug substance and drug product development, technology transfer, and GMP manufacturing
• Small molecule experience required
• Experience managing external partners (CMOs/CDMOs)
• Working knowledge of regulatory CMC requirements (FDA, ICH)
• Decision Making – has a systematic and methodical approach to making decisions, obtains relevant information, thinks beyond the immediate decision point, challenges assumptions and considers business implications of potential solutions
• People Leadership - Ability to lead and influence effectively
• Strong analytical, problem-solving, and planning skills
• Exceptional organizational and communication skills with the ability to work independently and collaboratively across all levels of the organization
• Positive Change Agent – curious, adaptable, and energizing leader with a global mindset
• Culture Ambassador - champions and models the organization’s values, fostering a culture of quality, inclusion, and continuous improvement across all teams
• Proficiency with project management tools (Smartsheet strongly preferred)
• Strong problem-solving, critical thinking, and risk management skills
• Ability to thrive in a fast-paced, dynamic environment with shifting priorities

Responsibilities

• Strategic Leadership: Lead and manage a portfolio of strategic CMC projects, ensuring alignment with enterprise priorities
• Define clear strategic priorities, project milestones, performance standards and expectations across a matrixed, cross-functional team of key stakeholders
• Act as a trusted liaison between executive leadership and project teams, translating strategic goals into actionable plans
• Ensure consistent application of project management best practices, including integrated project plans, timelines, risk registers, and governance
• Review and challenge project strategies, critical paths, and risk mitigation plans; escalate issues and trade-offs as needed
• Drive effective transition of projects from Research into Technical Operations and onward to commercial manufacture
• Partner cross-functionally with Manufacturing, Analytical Development, Quality, Regulatory, External Supply, Procurement, Finance, Clinical, and Commercial stakeholders
• Partner with CDMOs and external vendors to ensure aligned execution, transparent communication, and risk management
• Enable proactive portfolio visibility through integrated project plans, scenario planning, and resource forecasting
• Operational Excellence: Identify, Establish and continuously improve project management processes, tools, metrics, and operating models across Technical Operations to improve efficiency
• Identify capability gaps, capacity constraints, and opportunities for operational excellence
• Drive adoption of standardized tools and frameworks for program tracking and reporting
• Champion a culture of inclusion, continuous improvement and operational excellence
• Financial & Resource Management: Support development and accountability to budget and other financial planning deliverables across the function
• Optimize resource utilization and monitor KPIs to assess program health and impact
• Communications & Stakeholder Engagement: Prepare executive-level dashboards or MS PowerPoint milestone timelines to communicate progress and escalate risks
• Serve as primary communications conduit to external partners and internal cross-functional project teams, including executing project tasks and details
• Coordinate and document agenda and meeting notes to ensure smooth execution of functional activities and extended leadership meetings

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: Director
• Number of Employees: 101-250 employees