Director, Pharmaceutics

Ardelyx•Waltham, MA

7d•Hybrid

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, 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.

Requirements

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

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