Director, Analytical Development
About The Position
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 Director, Analytical Development is a leader who works as a member of an integrated team at Ardelyx overseeing small molecule analytical activities involving commercial drug substance and drug product with the exception of stability program management. This position partners cross-functionally with CMC, Quality, Manufacturing, Regulatory Affairs, Supply Chain, and external partners to ensure the successful execution of analytical strategies that support reliable product supply, regulatory compliance, and business objectives.
Requirements
- Bachelor’s Degree, advanced degree preferred, in chemistry or related discipline with 10+ years of industry experience or equivalent experience
- Strong experience required in analytical chemistry and associated regulatory requirements
- Experience working in close collaboration with technical, regulatory, quality assurance, project management, legal, finance, and supply chain functions, preferably in a cGMP operational environment
- Experience in leading and managing outsourced analytical activities and associated operating budgets
- Experience in preparing and defending regulatory documents
- Excellent communication skills and the ability to present to diverse internal and external audiences are requisite
Responsibilities
- Develop and lead execution of analytical strategies; prepare RFPs, select partners, and manage the successful execution of plans consistent with objectives and compliant with cGMP requirements
- Establish resource plans and operational budgets to meet corporate and departmental objectives
- Effectively integrate Commercial Analytical activities with those of sister CMC functions, including Drug Substance, Pharmaceutics, Supply Chain, Quality Assurance, and Regulatory Affairs
- Lead the preparation of analytical content for various regulatory documents (NDA, etc.) and effectively represent the function in interactions with regulatory authorities
- Effectively and professionally represent the Commercial Analytical function on various cross-functional teams including internal project teams as well as external steering and operating teams with contract manufacturing and/or corporate partners
- Evaluate and propose recommendations to senior leadership regarding analytical risks, opportunities, lifecycle strategies, and continuous improvement initiatives
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
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What This Job Offers
Job Type
Full-time
Career Level
Director
