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
• 10+ years of relevant pharmaceutical or biotechnology industry experience.
• Experience leading formulation development, processes, scale-up, transfer, characterization
• Experience supporting drug product development from early stages through commercialization.
• Proven success in managing CDMOs and external partners.
• Strong understanding of cGMP requirements, ICH guidelines, and global regulatory expectations.

🎁 Benefits

• Fully remote work from anywhere.
• Full-time, exempt position.
• Competitive salary range: $200,000 - $260,000 USD.
• Potential discretionary annual bonus.
• Clear opportunity for technical and strategic leadership.
• Collaboration with cross-functional teams.