Director, VTR Biologics and AIV

About This Role:

The Biologics VTR (Validation, Transfer, and Registration) and AIV (Analytical Instrument Validation) leader oversees the VTR team across Biologics and Combination Drugs as well as the AIV teams within Biogen Global Product and Quality Control (GPQC) organization. The incumbent ensures leadership and accountability for analytical method validation, transfer, and registration from pivotal through commercial stages for internal and external programs, as well as analytical instrument validation to enable new product testing capabilities. Your primary focus will be on ensuring analytical readiness to advance our portfolio and support both late-stage clinical and commercial products.

This pivotal role translates complex regulatory requirements, testing site logistics, and analytical sciences into a cohesive testing strategy, thereby enabling new product launches, market registrations, and sustained patient supply of commercial products. You will be at the forefront of innovation, driving acceleration and alignment among cross-functional teams to ensure Biogen's business goals and pipeline priorities are met.

This is a hybrid role to be based out of Research Triangle Park, NC.

What You'll Do:

• Lead and oversee method validation, transfers, regulatory filings, and global product launches.
• Implement advanced process control technologies to modernize control strategies.
• Ensure analytical instrument validation for GMP testing environments for both biologics and pharma laboratories and manufacturing spaces.
• Manage projects, timelines, resources, and budgets effectively.
• Evaluate and apply new technologies in GMP environments to enhance operations.
• Drive innovation and operational efficiency within the team.
• Ensure robust and compliant GMP testing methods are established and maintained.
• Facilitate cross-functional alignment, prioritize tasks, and balance workloads among sub-teams.
• Communicate effectively to asset leaders and senior management.
• Direct VTR managers and scientists in method development, optimization, and lifecycle management.
• Oversee quality initiatives such as CAPA, deviations, change control, and analytical program management.
• Collaborate with Analytical Development, Technical Development, Regulatory, Manufacturing, Quality Assurance, and Quality Control teams.

• Bachelor's degree in Life Sciences field with at least 12 years of experience within scientific related field, preferably the pharmaceutical industry. Advanced degree preferred.
• Strong knowledge of regulatory, compliance, GMP, and laboratory testing.
• Demonstrated technical experience with FDA, EMA, PMDA, CFDA, and global regulations as they relate to analytical methods, control strategies and specification..
• Advanced knowledge of end-to-end processes, CMC product lifecycle, phase-appropriate GMPs, QC and manufacturing operations, quality systems, ICH and regulatory compliance.
• Excellent technical writing, presentation, and oral/written communication skills.
• Experienced in authoring highly complex dossiers.
• Skillful leadership through complex issues and ability to drive cross-functional decisions.

• Experience in method development and analytical instrument validation.
• Proven track record of managing budgets and resource allocation effectively.

• Medical, Dental, Vision, & Life insurances
• Fitness & Wellness programs including a fitness reimbursement
• Short- and Long-Term Disability insurance
• A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
• Up to 12 company paid holidays + 3 paid days off for Personal Significance
• 80 hours of sick time per calendar year
• Paid Maternity and Parental Leave benefit
• 401(k) program participation with company matched contributions
• Employee stock purchase plan
• Tuition reimbursement of up to $10,000 per calendar year
• Employee Resource Groups participation