Director, VTR Biologics and AIV

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

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.

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 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.

Job Level:

Management

Additional Information

The base compensation range for this role is: $178,000.00-$245,000.00. Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity. Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance.

In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees’ and their families physical, financial, emotional, and social well-being;

• 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

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.

We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives. At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired.

We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.