💼 About This Role

You'll lead drug substance development for small molecule programs from pre-IND to phase 3, managing external partners and cross-functional CMC teams. Your work will drive regulatory submissions and ensure cGMP compliance for rare disease therapies.

🎯 What You'll Do

• Lead synthetic small molecule drug substance process development from pre-IND to phase 3
• Provide technical oversight of CROs, CMOs, and CDMOs for drug substance activities
• Author drug substance sections for IND, IMPD, NDA, and MAA submissions
• Manage program budgets, RFPs, and external partner governance

📋 Requirements

• PhD in Organic Chemistry or related with 6+ years industry experience
• Hands-on experience in small molecule drug substance development and technology transfer
• Expertise in synthetic route design, optimization, and control strategy
• Knowledge of global regulatory submissions and ICH guidelines

✨ Nice to Have

• Experience with Design of Experiments (DoE) and statistical tools
• Participation in process validation activities
• Experience managing multiple external partners concurrently

🎁 Benefits & Perks

• 🏖️ Flexible Work Model
• 💰 Competitive Compensation
• 🏥 Comprehensive Health Benefits
• 📈 Professional Development
• 🌟 Meaningful Impact on Rare Disease Patients

📨 Hiring Process

Estimated timeline: 2-4 weeks · AI estimate

1. 1Recruiter Call· 30 min
2. 2Hiring Manager Interview· 60 min
3. 3Technical Presentation· 60 min