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
• Demonstrated leadership in formulation and process development across clinical stages.
• Strong hands-on technical expertise in formulation development, process development, scale-up, and
• Proven experience with oral solid dosage forms and CDMO management in an outsourced model.
• Knowledge of FDA, EMA, ICH, cGMP, and global regulatory requirements for development and
• Experience, at drug product sub-component level yet sufficient for performance.

🎁 Benefits

• Generous paid time off and holidays tailored to your region.
• Stock options or equity package for participation in success.
• Comprehensive health insurance plan covering medical, dental, and vision (and depending on region).
• Short-term and long- as well as disability insurance.
• 401(k) with employer match, promotion and vesting.
• Life insurance and other program coverage where applicable.