Vice President, Analytical Development & Quality Control
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Job Location:
Waltham, MA - USA
Monthly Salary:
$ 302000 - 370000
Posted on:
Yesterday
Vacancies:
1 Vacancy
Department:
Job Summary
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 Vice President Analytical Development & Quality Control is the enterprise leader accountable for Ardelexs analytical chemistry activities. Reporting to the Chief Technical Operations Officer the VP of AD/QC will provide oversight of Ardelyxs array of contract testing laboratories across the companys portfolio of development-stage projects and commercial products. The VP of AD/QC will 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:
- 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 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:
- 15 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 is based in our Waltham MA office and requires onsite presence 2-3 days per week.
- 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 $302000 - $370000 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:
Exec
About Company
From discovery through commercialisation, all of us at Ardelyx are driven to advance targeted therapies where significant medical needs persist.
