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 deviation investigations and

🎯 Requirements

• Advanced degree in Pharmaceutical Sciences, Chemical Engineering, Chemistry, Pharmaceutics, or
• Demonstrated experience leading formulation and process development programs for therapeutic
• Strong technical expertise in formulation, process development, scale-up, technology transfer
• Experience from early clinical stages through commercialization, with commercial launch or
• Success while working with CDMOs and partners using a highly outsourced operating model.
• Strong knowledge of manufacturing, analytical testing, stability, specifications, and control

🎁 Benefits

• Fully remote from anywhere.
• Full-time salary position, exempt.
• Salary range: $200,000 - $260,000 USD.
• Discretionary annual bonus.
• Shape drug product lifecycle from early clinical to commercial.
• Collaborate with CMC, Quality, Regulatory, and teams.