💼 About This Role

You'll lead late-stage oral drug product development and commercial manufacturing strategies for a small molecule pipeline at an innovative biotech. You'll drive activities from Phase 2/3 through registration and validation, ensuring robust, scalable processes with CDMO oversight. This role offers the chance to make a direct impact on life-changing medicines in a collaborative environment.

🎯 What You'll Do

• Drive late-stage drug product activities including registration and validation campaigns
• Define and execute phase-appropriate activities for Phase 3 and NDA submissions
• Oversee formulation robustness, process characterization, and control strategy
• Provide technical and strategic oversight of CDMOs for scale-up and tech transfer

📋 Requirements

• PhD in Pharmaceutics, Pharmaceutical Sciences, or Chemical Engineering with 10+ years industry experience
• Demonstrated expertise in late-stage oral solid dosage form development and manufacturing
• Proven track record advancing compounds through Phase 3 and commercialization
• Deep technical expertise in unit operations such as tableting, granulation, and coating

✨ Nice to Have

• Experience with NDA preparation and inspection readiness
• Knowledge of QbD principles and control strategy development

🎁 Benefits & Perks

• 💰 Competitive base salary with annual bonus and equity participation
• 🏥 Comprehensive benefits package
• 🏢 Fast-paced biotech environment with bold ideas and collaboration