🛠 Tech Stack

💼 About This Role

You'll lead quality oversight of CMC lifecycle management for pharmaceutical products, working with contract manufacturing organizations to ensure cGMP compliance. Your work directly impacts the safety and efficacy of cancer treatments in a dynamic early-stage biotech environment.

🎯 What You'll Do

• Provide quality oversight for CMC lifecycle management of products.
• Conduct product release activities for all development phases.
• Review and approve master and executed batch records.
• Coordinate QP release and interact with external contract manufacturers.

📋 Requirements

• Bachelor's degree in biology, chemistry, or life sciences.
• 5+ years experience in Quality functions supporting cGMP manufacturing.
• Direct experience with GMP manufacturing of small molecule products.
• Strong knowledge of cGMP regulations for pharmaceutical development.

✨ Nice to Have

• Experience with GMP manufacturing oversight of small molecule drug substances.
• Working knowledge of MS Word, Teams, Veeva, SharePoint, Smartsheet.
• Knowledge of cGMP for commercial product manufacturing and testing.

🎁 Benefits & Perks

• 💰 Competitive salary within $125,000-$145,000 range.
• 🏥 Medical, dental, and vision insurance.
• 🏖️ Generous paid time off including summer and winter shutdown.
• 📈 401(k) retirement savings plan.
• 🤝 Equal opportunity employer.

📨 Hiring Process

Estimated timeline: 2-4 weeks · AI estimate

1. 1Phone Screen with Recruiter· 30 min
2. 2Hiring Manager Interview· 60 min
3. 3Technical/Team Interview· 60 min
4. 4Offer· 30 min