Job Description
📋 Description Collaborate with CMC teams to design drug substance/product control strategies across lifecycle. Author and review drug substance and drug product sections for IND/CTA/NDA/MAA submissions. Prepare responses to health authority queries on quality. Maintain quality risk assessments per ICH M7, ICH Q3D, and nitrosamines. Advise development teams on starting materials, specifications, and manufacturing processes. Identify regulatory issues with potential cross project impact. 🎯 Requirements PhD with 7+ years relevant experience, or BS/MS with 10+ years relevant experience. Experience in CMC development and regulatory authoring preferred. Background in drug product or analytical development is a plus. Familiarity with FDA/EMA/ICH guidelines for INDs/NDAs/MAAs. Understanding of cGMP and regulatory requirements for drug substance/product manufacturing. Knowledge of analytical method development/validation and stability requirements. 🎁 Benefits 100% employer-paid medical, dental, and vision premiums for you and dependents. 401(k) with employer match. Employee Stock Purchase Program (ESPP). Hybrid work model with flexibility. Flexible PTO and company holidays. Pre-tax commuter benefits.
