Director, VTR Biologics and AIV
Biogen
3 days ago
Remote friendly (Triangle, NC)
United States
Other
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.
Required Skills
- 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.
Benefits (highlights)
- 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).
- 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.
Required Skills
- 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.
Benefits (highlights)
- 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).