Associate Director, Pharmaceutics

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.

This is a hybrid role (2-3 days in office) at our Waltham, MA headquarters.

Position Summary:

The Associate Director, Pharmaceutics is responsible for assisting in 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 an important 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:

Assist in planning and execution 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;
Insure the successful execution of plans consistent with corporate objectives and compliant with cGMP requirements

Provide technical input 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 operating teams with contract manufacturing 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

Support 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 8 - 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 NDAsAbility 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…