Director, VTR Biologics and AIV

What You’ll Do

• Lead and oversee analytical method validation, transfers, regulatory filings, and global product launches across biologics/combination drugs.
• Ensure analytical instrument validation for GMP testing environments across biologics/pharma lab and manufacturing spaces.
• Implement advanced process control technologies; evaluate and apply new technologies in GMP environments.
• Manage projects, timelines, resources, and budgets; drive innovation and operational efficiency.
• Establish and maintain robust, compliant GMP testing methods.
• Facilitate cross-functional alignment; prioritize tasks and balance sub-team workloads.
• Communicate with asset leaders and senior management.
• Direct VTR managers/scientists in method development, optimization, and lifecycle management.
• Oversee quality initiatives (CAPA, deviations, change control) and analytical program management.
• Collaborate with Analytical Development, Technical Development, Regulatory, Manufacturing, Quality Assurance, and Quality Control.

• Bachelor’s degree in Life Sciences with 12+ years in a scientific role (preferably pharma); advanced degree preferred.
• Strong knowledge of regulatory/compliance, GMP, and laboratory testing.
• Experience with global regulations (e.g., FDA, EMA, PMDA, CFDA) for analytical methods/control strategies/specifications.
• End-to-end CMC product lifecycle knowledge, phase-appropriate GMPs, QC/manufacturing operations, quality systems, ICH/regulatory compliance.
• Excellent technical writing/presentation and oral/written communication.
• Experience authoring highly complex dossiers.
• Leadership through complex issues; cross-functional decision-making.
• Experience in method development and analytical instrument validation.
• Proven experience managing budgets and resource allocation.

• Base compensation range: $178,000–$245,000.
• Medical, dental, vision, and life insurance; fitness reimbursement; disability; paid vacation and end-of-year shutdown; holidays; sick time; paid maternity/parental leave; 401(k) match; stock purchase plan; tuition reimbursement (up to $10,000/year).