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Ardelyx, Inc. · 1 hour ago

Associate Director, CMC Operations

Waltham, MA

Full-time

Onsite

Lead/Staff, Director/Executive

$178K/yr - $200K/yr

8+ years exp

Ardelyx, Inc. is a biopharmaceutical company focused on developing innovative medicines for unmet medical needs. The Associate Director, CMC Operations will lead cross-functional activities within the CMC organization to ensure timely execution of pharmaceutical development, manufacturing, and regulatory deliverables, acting as the operational hub between various teams and external partners.

BiotechnologyHealth CareMedical

Comp. & Benefits

Responsibilities

Develop, maintain, and manage detailed CMC project timelines across product lifecycle phases (development, validation, technology transfer, registration, and commercial supply)

Lead and facilitate cross-functional meetings, ensuring clear communication of priorities, risks, and deliverables

Monitor project progress and proactively identify and mitigate risks to ensure adherence to timelines and budgets

Lead scenario planning and “what-if” analyses to support strategic decision-making

Act as the primary operational liaison between Technical Operations, Quality, Regulatory, Analytical, and Supply Chain teams

Oversee change controls and resolution of technical and logistical issues by partnering with external CMOs/CDMOs to align project milestones

Support governance and communication with senior management through regular project updates and dashboards

Ensure alignment of CMC documentation with regulatory and quality expectations (e.g., IND / NDA submissions)

Maintain up-to-date project documentation, decision logs, and meeting summaries

Drive process improvement initiatives to optimize CMC workflows, document review cycles, and communication with partners

Contribute to development of best practices, templates, and metrics within the Technical Operations organization

Qualification

CMC project managementDrug developmentGMP manufacturingRegulatory CMC requirementsProject management toolsRisk managementCommunication skillsProblem-solving skillsCritical thinking

Required

Bachelor's degree in Chemistry, Pharmaceutical Sciences, Chemical Engineering, or related field preferred with 8 - 10 years of experience in pharmaceutical or biotech industry or equivalent experience

3+ years in CMC project management or related technical operations role

Strong understanding of drug substance and/or drug product development, technology transfer, and GMP manufacturing

Experience managing external partners (CMOs/CDMOs)

Working knowledge of regulatory CMC requirements (FDA, ICH)

Exceptional organizational and communication skills with ability to lead through influence

Proficiency with project management tools (MS Project, Smartsheet, or equivalent)

Strong problem-solving, critical thinking, and risk management skills

Ability to thrive in a fast-paced, dynamic environment with shifting priorities

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

Company

Ardelyx, Inc.

Ardelyx was founded with a mission to discover, develop and commercialize innovative, first-in-class medicines that meet significant unmet medical needs.

Founded in 2007

Fremont, California, USA

201-500 employees