Associate Director, CMC Operations

Description

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 CMC Operations will lead and coordinate cross-functional activities within the Chemistry Manufacturing and Controls (CMC) organization to ensure timely execution of pharmaceutical development manufacturing and regulatory deliverables. This role will serve as the operational hub between Technical Operations Quality Regulatory Affairs Analytical Development Supply Chain and external partners (CDMOs/CMOs) driving alignment accountability and on-time delivery of CMC objectives from clinical through commercial stages.

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

Qualifications:

• Bachelors 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

The anticipated annualized base pay range for this full-time position is $178000-$200000. 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.

Required Experience:

Director