Scientist I, Quality Control (Reference Standards and Method Performance)

Responsibilities

• 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

Requirements

• 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
• Job Level: Professional
• Additional Information
• The base compensation range for this role is: $93,000.00-$121,000.00
• 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 ; 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?
• All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, nati

Benefits

Additional Information

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.

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