Executive Director, Analytical Development & Quality Control

Description

Ardelyx is a commercial-stage biopharmaceutical company focused on redefining treatment approaches for patients with significant unmet medical needs. By combining scientific innovation with a collaborative, purpose-driven culture, we strive to create meaningful impact for patients.


Team Ardelyx is united by a shared mission and guided by our core values: Passionate, Fearless, Dedicated, and Inclusive.


We foster an inclusive environment where employees are respected, supported, and empowered to make an impact - both within our company and in the lives of patients we serve. Position Summary: The Executive Director, Analytical Development & Quality Control (AD/QC), is the enterprise leader accountable for Ardelex's analytical chemistry activities. Reporting to the Chief Technical Operations Officer, the Executive Director will provide oversight of Ardelyx's array of contract testing laboratories across the company's portfolio of development-stage projects and commercial products. The Executive Director will collaboratively build, improve, and scale a modern, inspection ready analytical chemistry capability that ensures reliable supply, strengthens compliance, and champions a proactive, high-engagement technical and quality culture across internal teams and external partners. Responsibilities:

• Provide strategic roadmap for the AD/QC department, aligning it with the overall company objectives and regulatory requirements
• Partner with other functions (e.g. Supply Chain, CMC, Quality Assurance, and Regulatory Affairs) to develop and implement appropriate control strategies for all stages of product development and manufacturing
• Lead and collaborate with other departments to implement quality and process improvement initiatives
• Oversee the development, validation, implementation, and life-cycle management of analytical methods for the analysis of raw materials, intermediates, drug substance, and drug product
• Ensure with functional leaders that all AD/QC activities are conducted in stage-appropriate accordance with current Good Manufacturing Practices (cGMPs) and relevant regulatory requirements
• Author and review IND/NDA Module 3 sections, with primary responsibility for Characterization/Impurities, Analytical Methods/Validation, Batch Analysis, Specifications, and Stability
• Manage and develop a team of skilled professionals, providing mentorship and fostering a culture of excellence, innovation, collaboration, and teamwork
• Develop and maintain productive relationships with outsourced analytical testing partners, actively managing all associated activities
• Allocate internal and external resources effectively to meet departmental and corporate timelines and objectives
• Develop and monitor Key Performance Indicators (KPIs) for the AD/QC department
• Collaborate with QA in the preparation and presentation of reports to management on quality-related metrics and compliance status

Qualifications:

• An advanced degree (MS or Ph.D.) in Chemistry or a related discipline
• 12+ years pharmaceutical industry experience, with a strong background in the AD and QC functions, phase-appropriate requirements, and at least 10 years of experience in a managerial role, or equivalent experience
• Proven track record of successful collaboration with key stakeholder functions (e.g. Supply Chain, CMC, Quality Assurance, and Regulatory Affairs)
• In-depth knowledge of current regulatory requirements and guidelines for analytical development and quality control (cGMP, ICH, FDA, etc.)
• Direct experience as a lead author of relevant Module 3 sections and supporting regulatory authority inspections
• Experience with computerized systems (e.g. LIMS, Veeva, etc.) and their associated compliance requirements
• Strong technical problem-solving and decision-making skills with the ability to interface with a broad range of internal and external stakeholders at all levels of the organization

Work Environment:

• The position may be based in either of Ardelyx's two locations (Waltham, MA or Newark, CA)
• The ability to travel to Ardelyx's other locations and external testing labs is required (up to 20 %)

The anticipated annualized base pay range for this full-time position is $267,000 - $327,000. 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.