Director, Pharmaceutics

Position Summary:

The Director, Pharmaceutics is responsible for leading the planning and execution of Drug Product (DP) activities across a portfolio of programs at Ardelyx. Reporting to the Senior Director, Pharmaceutics, this role partners closely with CMC, Supply Chain, Quality Assurance, Regulatory Affairs and various cross-functional internal and external partners to direct activities associated with product development and/or manufacturing in alignment with business objectives.

This role serves as a key cross-functional leader, driving collaboration, managing external development and manufacturing partners, identifying and mitigating technical and supply risks, and supporting the successful advancement of Ardelyx's product portfolio.

Responsibilities:

• Manage all Drug Product (DP) efforts, including formulation development (adult and pediatric), process development, tech transfer, and the manufacture of DP for clinical and commercial purposes
• Manage phase-appropriate DP project plans; develop outsourcing strategies, prepare RFPs, and manage the successful execution of plans consistent with corporate objectives and compliant with cGMP requirements
• Provide assistance and technical leadership on the preparation of the DP section of various regulatory documents (IND, NDA, etc.), ensuring scientific accuracy and regulatory compliance
• Represent the DP function, and when needed the broader Tech Ops 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
• Integrate DP activities with those of sister CMC functions, Supply Chain, Quality Assurance, and Regulatory Affairs, ensuring effective cross-functional communication and execution throughout the product lifecycle
• Work with Supply Chain to ensure a continuous and uninterrupted supply of CTM to clinical sites and commercial materials to market
• Drive continuous improvement initiatives that enhance product quality, manufacturing efficiency, operational excellence, and overall Drug Product development capabilities

Qualifications:

• B.S. degree in Pharmaceutics, Pharmaceutical Sciences, or Chemical Engineering, with 10+ years of related experience or equivalent experience
• Experience in the areas of formulation development, DP process development, tech transfer, and manufacturing
• Experience working in close collaboration with technical, regulatory, quality, project management, legal, finance, and supply chain functions, in a cGMP operational environment
• Experience in managing outsourced development, tech transfer, and manufacturing efforts as well as associated operating budgets
• Experience in preparing and defending regulatory documents including briefing books for regulatory meetings, INDs, and NDAs
• Ability to work in a "hands on" environment while setting priorities, meeting stringent timelines, and managing departmental budgets effectively and efficiently
• Excellent communication skills and the ability to shape, frame, and present to diverse internal and external audiences are requisite
• Proven ability to build strong relationships with internal stakeholders and external partners while effectively influencing decisions across multiple functional areas
• Periodic travel to manufacturing and other partner sites is required (approximately 10 - 20% of time)