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
• Provide technical oversight of GMP manufacturing campaigns, including batch documentation
• Analyze formulation, manufacturing, analytical, and stability data to identify trends, troubleshoot
• Develop scalable, phase-appropriate manufacturing and control strategies supporting product

🎯 Requirements

• 10+ years of relevant pharmaceutical or biotechnology industry experience
• Demonstrated experience leading therapeutic product formulation and process development programs
• Strong technical expertise in formulation development, process development, scale-up, technology
• Experience supporting drug product development from early clinical through commercialization
• Proven success managing CDMOs and external partners in a highly outsourced model
• Strong knowledge of drug product manufacturing, analytical testing, stability programs, and control

🎁 Benefits

• Fully remote environment
• Full-time, exempt role
• Salary: $200,000–$260,000 USD plus potential bonus
• Remote work
• Responsibility and independence
• Opportunities for professional growth