Senior Director, CMC Operations
Ardelyx, Inc., Waltham, MA, United States
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.
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; elevate 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 elevate 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
The position is hybrid, working out of the Waltham, MA or Newark, CA location 2‑3 days per week.
Qualifications
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
Work Environment
The position is hybrid, working out of the Waltham, MA or Newark, CA location.
Travel is estimated at 15 % but will flex depending on business need.
The anticipated annualized base pay range for this full‑time position is $250,000 - $306,000. 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.
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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.
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; elevate 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 elevate 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
The position is hybrid, working out of the Waltham, MA or Newark, CA location 2‑3 days per week.
Qualifications
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
Work Environment
The position is hybrid, working out of the Waltham, MA or Newark, CA location.
Travel is estimated at 15 % but will flex depending on business need.
The anticipated annualized base pay range for this full‑time position is $250,000 - $306,000. 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.
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