Director, Quality Analytical Technical Lead, Small Molecule

📋 Description

• Global analytical lifecycle owner for small-molecule products
• Lead analytical strategy across major markets
• Partner with QA, Regulatory, supply, and tech partners
• Drive method updates, validation, verification, and transfers
• Own release specs, stability, and robustness improvements
• Support regulatory submissions and inspections

🎯 Requirements

• Bachelor’s + 10+ years biopharma exp; advanced degree preferred
• Leadership in GMP QC/analytical sciences for commercial products
• Expertise in HPLC/UPLC, GC, dissolution, residual and elemental impurities
• Know-how in validation, stability trending, statistics, and lifecycle management
• Data integrity, risk-based decisions, and regulatory documentation skills
• Strong writing, communication, and cross-functional collaboration

🎁 Benefits

• Base salary $168,000–$228,000
• Annual bonus eligibility and equity opportunities
• Comprehensive medical, dental, vision
• 401(k) with matching; FSA/HSA options
• Life insurance and paid time off
• Remote-based position in the United States