Director, VTR Biologics and AIV

Biogen; Milwaukee (WI); On-site; USD 178,000 - 245,000; Full time

Benefits offered by this job

Medical, Dental, Vision, and Life insurance

Fitness & Wellness programs

401(k) program with company match

Tuition reimbursement up to $10,000

Job summary

Biogen is hiring an experienced leader for the VTR and AIV teams focused on analytical method validation and regulatory compliance. The role requires overseeing projects at pivotal stages, driving innovation, and ensuring effective communication with senior management.

With at least 12 years in the pharmaceutical industry, candidates should have substantial knowledge of regulatory compliance, GMP environments, and excellent leadership abilities. Comprehensive benefits and competitive salary ranging from $178,000 to $245,000 are offered.

Qualifications

• At least 12 years of experience in a scientific or pharmaceutical industry.
• Strong knowledge of GMP and laboratory testing.
• Experience with FDA and global regulations related to analytical methods.

Responsibilities

• Lead method validation, transfers and regulatory filings.
• Manage projects, timelines, resources, and budgets.
• Drive innovation and operational efficiency within the team.

Skills

Regulatory Compliance

Analytical Method Validation

Leadership

Cross-Functional Collaboration

Education

Bachelor’s degree in Life Sciences

Job description

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.

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.

Who You Are

You are an experienced leader who thrives in a dynamic, fast-paced environment. You possess an innate ability to drive innovation and operational excellence while maintaining a strategic focus. Your strong communication skills allow you to work effectively with cross-functional teams and senior stakeholders. You are passionate about advancing scientific processes and technologies, with a keen eye for detail and a commitment to compliance and quality standards. Your leadership style is collaborative, fostering a culture of alignment and prioritization to achieve Biogen’s business objectives.

Required Skills

• Bachelor’s degree in Life Sciences with at least 12 years of experience in a scientific or pharmaceutical industry; advanced degree preferred.
• Strong knowledge of regulatory, compliance, GMP, and laboratory testing.
• Experience with FDA, EMA, PMDA, CFDA, and global regulations related to analytical methods, control strategies and specifications.
• 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.
• Experience 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.

Compensation

The base salary range for this role is $178,000.00 – $245,000.00, based on relevant skills & experience, job location, and internal equity. Regular employees are eligible for both short‑term and long‑term incentives, including cash bonus and equity awards.

Benefits

• Medical, Dental, Vision, and Life insurance
• Fitness & Wellness programs with fitness reimbursement
• Short‑ and Long‑Term Disability insurance
• Minimum of 15 days paid vacation and 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 with company match
• Employee stock purchase plan
• Tuition reimbursement up to $10,000 per calendar year
• Employee Resource Groups participation

EEO Statement

All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E‑Verify Employer in the United States.