Director, Drug Product

📋 Description

• Lead drug product CMC strategy and execution for small molecule programs from early clinical
• Direct phase-appropriate formulation and process development for oral solid dosage forms, including
• Provide technical leadership for technology transfers, process characterization, process
• Select, onboard, and provide technical oversight of CDMOs and external partners supporting drug
• Establish expectations, work plans, timelines, budgets, and performance measures for external
• Provide technical oversight of GMP manufacturing campaigns, including batch documentation

🎯 Requirements

• Advanced degree in Pharmaceutical Sciences, Chemical Engineering, Chemistry, Pharmaceutics, or
• Proven experience leading therapeutic product formulation and process development programs.
• Strong expertise in formulation development, process development, scale-up, technology transfer
• Experience supporting drug product development from early clinical to commercialization; launch or
• Proven success managing CDMOs and external partners in an outsourced model.
• Strong knowledge of product manufacturing, analytical testing, stability programs, specifications

🎁 Benefits

• Fully remote working environment from anywhere.
• Full-time, exempt position with significant technical and strategic leadership responsibility.
• Expected salary range $200,000–$260,000 USD, determined by experience and location.
• Potential discretionary annual bonus based on individual and organizational performance.
• Opportunity to lead drug product strategy across the full development lifecycle.
• High-impact collaboration with CMC, Quality, Regulatory, and other leadership teams.