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, Pharmaceutics, or related discipline with 10+ years of
• Demonstrated experience leading drug product formulation and process development
• Strong technical expertise in CMC, scale-up, and GMP manufacturing
• Experience managing CDMOs and external partners
• Knowledge of cGMP, ICH, and global regulatory requirements
• Experience authoring and reviewing CMC regulatory submissions

🎁 Benefits

• Fully remote working environment
• Full-time position with technical and strategic leadership opportunity
• Salary range of $200,000–$260,000 USD
• Potential discretionary annual bonus
• Opportunity to impact drug product strategy
• Collaboration with cross-functional teams