Director, Pharmaceutics

Scorpion Therapeutics; Waltham (MA); Hybrid; USD 180,000 - 250,000; Full time

Job summary

Ardelyx is seeking a Director of Pharmaceutics to lead drug product formulation, DP process development, tech transfer, and manufacturing for clinical and commercial programs. The role involves directing DP efforts across phases and coordinating with external partners to ensure product quality and supply chain alignment.

Responsibilities include developing outsourcing strategies, preparing INDs/NDAs, and integrating with QA, CMC, Regulatory, and Supply Chain teams.

Qualifications

• B.S. degree in pharmaceutics, pharmaceutical sciences, or chemical engineering with 10+ years in DP formulation and manufacturing.
• Proven track record in managing outsourced development and regulatory submissions (INDs, NDAs).
• Experience leading cross-functional teams across QA, CMC, Regulatory, and Supply Chain.

Responsibilities

• Direct drug product formulation and DP process development across all phases.
• Oversee tech transfer and external partners to support clinical and commercial programs.
• Develop outsourcing strategies and regulatory documentation for submissions.
• Drive continuous improvement for product quality and operational efficiency.

Skills

Formulation development

DP process development

cGMP manufacturing

Outsourcing management

Regulatory submissions

Cross-functional collaboration

Education

B.S. in Pharmaceutics, Pharmaceutical Sciences, or Chemical Engineering

Job description

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.

High Value

biologics/chemical modalities, cGMP environment, clinical and commercial supply chain, regulatory document preparation, cross-functional leadership, travel 10-20%.

Work Setup

hybrid (2-3 days in Waltham, MA).