Scientist I, Quality Control (Reference Standards and Method Performance)
Biogen
Quality Assurance
Research Triangle Park, Durham, NC, USA
This position is hybrid to our Research Triangle Park, NC site and will require frequent on-site presence
About This Role
As a Scientist I in Quality Control, you will lead technical, tactical, and strategic quality activities supporting RSQM (reference standards and qualified materials) used in biological programs. This role manages multiple projects simultaneously, driving initiatives related to material qualification, sourcing, inventory, shipping, regulatory compliance, method performance review, and continuous quality improvement. You will serve as a key quality representative, partnering with cross-functional stakeholders to resolve technical issues and ensure materials meet GMP and regulatory expectations. The position plays a critical role in maintaining quality standards and method performance while supporting business objectives and inspection readiness. Reporting within the Quality organization, you will contribute to the successful execution of RSQM programs and broader quality system initiatives.
What You’ll Do
Lead quality activities for multiple RSQM programs and projects
Author, review, approve, and maintain GMP documents, protocols, and reports
Evaluate change controls, risk assessments, and regulatory documentation
Lead and support continuous improvement initiatives across QC processes
Collaborate with cross-functional teams as the QC RSQM representative
Ensure compliance with GMP requirements and regulatory expectations
Prepare technical documentation and reports supporting RSQM activities
Support internal and external inspections and audit readiness
Additional duties as required
Who You Are
You are a quality-focused scientific professional who thrives in a fast-paced, highly regulated environment. You enjoy solving complex technical challenges, collaborating across functions, and driving continuous improvement while maintaining the highest quality standards.
Required Skills
PhD with 2+ years of experience, Master's degree with 3+ years of experience, or Bachelor's degree with 5+ years of experience in a GMP or cGMP quality laboratory environment
Hands on large molecule method experience: bioassay (potency or impurities) or biochemistry (identity, impurities, characterization)
Strong technical writing abilities
Ability to multi task
Preferred Skills
Evaluation of method performance
Project management 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:
- 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
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 DE&I efforts.
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.