🛠 Tech Stack

💼 About This Role

You'll provide technical and strategic oversight of all outsourced QC activities for small molecule programs across development and commercialization. Your work ensures compliant, phase-appropriate, and inspection-ready execution, supporting rare disease patients with life-changing treatments. This role leads QC governance for external partners in a 100% outsourced model.

🎯 What You'll Do

• Provide end-to-end QC oversight for outsourced small molecule drug substance and drug product programs.
• Lead technical review and approval of analytical data, method validation, and stability programs.
• Manage selection, qualification, and performance of CMOs and contract laboratories.
• Collaborate cross-functionally on regulatory submissions, inspections, and audits.
• Act as QC representative in cross-functional CMC teams.

📋 Requirements

• Bachelor's degree with 14+ years or Master's with 10-12+ years or PhD with 8-10+ years of GMP experience.
• Minimum 5-8+ years of direct CMC QC experience with small molecules including commercial assets.
• Hands-on expertise with analytical techniques like HPLC, LC-MS, GC, dissolution, etc.
• Strong knowledge of ICH, FDA, EMA, USP, Ph. Eur. requirements.
• Proven experience overseeing external QC laboratories and CMOs.

✨ Nice to Have

• Experience with rare or ultra-rare disease development models.
• Experience with biologics QC for hybrid portfolios.
• Oligonucleotide QC experience.

🎁 Benefits & Perks

• 🏖️ Flexible work model with onsite 2-3 days per week
• 📈 Professional growth and learning opportunities
• 💊 Meaningful impact on rare disease patients
• 🤝 Collaborative ecosystem and inclusive culture

📨 Hiring Process

Estimated timeline: 2-4 weeks · AI estimate

1. 1Recruiter Screen· 30 min
2. 2Hiring Manager Interview· 1 hour
3. 3Panel Interview· 2 hours