Senior Director, CMC Operations

Ardelyx•Waltham, MA

23h•Hybrid

About The Position

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

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
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
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
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