Executive Director, Analytical Development & Quality Control

Ardelyx

Job Location:

Waltham, MA - USA

Monthly Salary: $ 267000 - 327000

Posted on: 2 days ago

Vacancies: 1 Vacancy

Department:

Manufacturing

Job Summary

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 Ardelexs analytical chemistry activities. Reporting to the Chief Technical Operations Officer the Executive Director will provide oversight of Ardelyxs array of contract testing laboratories across the companys 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 Ardelyxs two locations (Waltham MA or Newark CA)
The ability to travel to Ardelyxs other locations and external testing labs is required (up to 20 %)

The anticipated annualized base pay range for this full-time position is $267000 - $327000. 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

DescriptionArdelyx 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 Arde...