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North Carolina, United States
Onsite
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 Biogen's portfolio.
What You’ll 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 and review 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 late‑stage development and commercial products
Provide technical stewardship and oversight of contract laboratories supporting multiple regulatory markets. Manage cross‑site and cross‑functional 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.
Required Skills
Bachelor's and 7+ years, Master's and 5+ years, or PhD and 3+ years of relevant experience in analytical development, validation, technology transfer, or pharmaceutical quality. Degree should be in a scientific discipline, with chemistry highly preferred
Extensive experience working within GMP-regulated pharmaceutical environments
Solid working knowledge of international regulatory guidelines, such as ICH, USP, EP, JP, ChP. and experience with global regulatory filings
Strong working knowledge of analytical techniques and instrumentation, including LC/MS, (U)HPLC, GC, Karl Fischer, dissolution, and compendial analyses
Experience with managing cross-functional projects and project management tools for tracking and communicating progress
Proficiency in statistical data analysis with JMP or other software
Stakeholder communication and cross functional collaboration
Ability to travel up to 30% domestic and internationally
Preferred Skills
Experience with antisense oligonucleotide (ASO) products
Experience supporting global commercial product registrations
CMC experience
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:
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 on to 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.
