💼 About This Role

You'll lead formulation and process development for small molecule programs from discovery through clinical phases, setting drug product strategy and driving execution. You will oversee CDMO management, scale-up, and technology transfer to enable global registrations. This role offers the chance to work with an AI-driven drug discovery platform in a fast-paced environment.

🎯 What You'll Do

• Define and execute formulation and process strategies in cross-functional matrix teams.
• Lead formulation design for oral solid dosage forms using QbD principles.
• Manage CDMO selection, oversight, and tech transfer for clinical manufacturing.
• Author and review Module 3 drug product sections for global regulatory filings.

📋 Requirements

• PhD in Pharmaceutics with 10+ years industry experience or equivalent.
• Deep expertise in oral solid dosage form development and scale-up.
• Experience with enabling formulations like ASD, spray drying, hot melt extrusion.
• Proven success managing CDMOs and delivering clinical supply on aggressive timelines.

✨ Nice to Have

• Expertise in OSD unit operations (blending, granulation, compression, coating).
• Track record of NDA/MAA submissions and health authority interactions.
• Knowledge of GLP, cGMP, ICH, and global regulatory requirements.

🎁 Benefits & Perks

• 💰 Competitive pay with $196K-$245K range
• 🏥 Company paid healthcare
• 🏖️ Uncapped vacation
• 💼 401K matching
• 📈 Flexible spending accounts