Director, Pharmaceutics

Role: Director, Pharmaceutics leading drug product formulation, process development, tech transfer, and manufacturing for clinical and commercial programs at Ardelyx. Responsibilities: manage all DP efforts across phases, develop outsourcing strategies, prepare regulatory documents (INDs, NDAs), and ensure integration with Supply Chain, QA, CMC, and Regulatory teams; drive continuous improvement for product quality and operational efficiency; oversee external partners and technical teams. Requirements: B.S. in Pharmaceutics, Pharmaceutical Sciences, or Chemical Engineering; 10+ years of experience in formulation, DP process development, and cGMP manufacturing; proven track record in managing outsourced development and regulatory submissions. Preferred: experience in pediatric formulation and cross-functional collaboration; strong communication and stakeholder influence skills. HighValue: biologics/chemical modalities, cGMP environment, clinical and commercial supply chain, regulatory document preparation, cross-functional leadership, travel 10-20%. WorkSetup: hybrid (2-3 days in Waltham, MA).