Scientist II, Pharma QC Validation, Transfer and Registration (VTR)

About This Role

As a Scientist II within Pharma Validation Transfer and Registration (VTR) you will serve as a subject matter expert supporting analytical method validation transfer investigation and regulatory filings for small molecule and antisense oligonucleotide (ASO) products. This role partners closely with Quality Control Analytical Development Manufacturing Science Regulatory Affairs and external laboratories to ensure analytical methods are robust compliant and ready for commercial and late-stage development programs. You will lead cross-functional initiatives provide technical oversight of contract laboratories and drive successful execution of validation and technology transfer activities across global markets. Reporting to the Director of VTR you will play a critical role in ensuring product quality regulatory compliance and lifecycle management for Biogens portfolio.

What Youll Do

• Provide subject matter expertise in analytical methodologies for small molecule and/or antisense oligonucleotide (ASO) drug substances and drug products in a GMP environment

• Design lead execute and coordinate analytical method validation and technology transfer activities within internal QC laboratories and external contract laboratories

• Author andreview analytical procedures and validation section of regulatory filings and address the questions from the global regulatory agencies

• Author and review transfer and validation protocols/reports and perform statistical data analysis as needed

• Troubleshoot and lead complex analytical investigations; optimize methods to ensure robustness QC suitability and compliance with global regulatory requirements

• Evaluate develop validate and implement new analytical technologies in support of latestage development and commercial products

• Provide technical stewardship and oversight of contract laboratories supporting multiple regulatory markets. Manage crosssite and crossfunctional projects establish timelines and priorities communicate progress to stakeholders and leadership

• Maintain effective collaboration with QC AD Manufacturing Regulatory and Quality Assurance partners and coach or mentor junior scientists

• Other duties as assigned

Who You Are

You are a highly technical analytical scientist who enjoys solving complex scientific challenges and influencing cross-functional teams. You thrive in a fast-paced GMP environment balancing technical expertise project leadership and regulatory compliance to drive successful outcomes.

Additional Information

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; including but not limited to:

• 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 $10000 per calendar year
• Employee Resource Groups participation

Why Biogen

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.Read onto learn more about our Biogen.

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.