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
• Experience leading formulation and process development for small molecule programs
• Expertise in formulation, process development, scale-up, tech transfer, validation, and GMP
• Experience from early clinical through commercialization
• Managing CMOs/CDMOs in outsourced model
• Knowledge of analytical testing, stability, specifications, and control strategies

🎁 Benefits

• Fully remote work environment
• Full-time, salary of $200,000-$260,000 USD
• Annual bonus potential
• Lead drug product strategy across lifecycle
• Collaboration with cross-functional teams
• Ownership of external CDMO relationships