Director, Biologics VTR & AIV Validation

Biogen, Inc.; North Carolina; Hybrid; USD 178,000 - 245,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

Life Insurance

Fitness & Wellness reimbursement

Disability Insurance

Paid vacation & shutdown days

Paid holidays & personal time off

Sick time

401(k) with company match

Employee stock purchase plan

Tuition reimbursement

Job summary

Biogen's VTR and AIV leader will oversee method validation, transfer, and regulatory filings across Biologics and Combination Drugs, ensuring readiness for late-stage and commercial products. This senior role drives cross-functional alignment and innovation in GMP environments within the GPQC organization at RTP, NC.

The role demands strategic leadership, advanced scientific knowledge, and a track record of delivering compliant validation programs, while managing budgets and timelines across

Qualifications

• Bachelor's degree in Life Sciences with 12+ years in scientific field, preferably pharma.
• Advanced degree preferred.
• Strong knowledge of regulatory, compliance, GMP, and lab testing.
• Experience with FDA/EMA/PMDA/CFDA regulations relating to analytical methods and validation.
• Knowledge of CMC product lifecycle and ICH guidelines.
• Excellent technical writing and presentation skills.
• Experience authoring complex dossiers.
• Proven leadership through complex issues and cross-functional decisions.
• Experience in method development and analytical instrument validation.
• Budgets and resource allocation experience.

Responsibilities

• Lead and oversee method validation, transfers, regulatory filings, and global product launches.
• Implement advanced process control technologies to modernize control strategies.
• Ensure instrument validation for GMP testing in biologics and pharma labs.
• Manage projects, timelines, resources, and budgets effectively.
• Evaluate new technologies in GMP environments to enhance operations.
• Drive innovation and operational efficiency within the team.
• Ensure robust GMP testing methods are established and maintained.
• Facilitate cross-functional alignment and prioritization.
• Communicate effectively to asset leaders and senior management.
• Direct VTR managers and scientists in method development and lifecycle management.
• Oversee CAPA, deviations, change control, and analytics program management.
• Collaborate with Analytical Development, Regulatory, Manufacturing, QA, and QC teams.

Skills

Leadership

Cross-functional collaboration

Regulatory compliance

Strategic thinking

Communication

Budget management

Project management

Technical writing

Education

Bachelor's degree in Life Sciences

Advanced degree

Job description

Biogen's VTR and AIV leader will oversee method validation, transfer, and regulatory filings across Biologics and Combination Drugs, ensuring readiness for late-stage and commercial products. This senior role drives cross-functional alignment and innovation in GMP environments within the GPQC organization at RTP, NC.

The role demands strategic leadership, advanced scientific knowledge, and a track record of delivering compliant validation programs, while managing budgets and timelines across