Senior Manager, Reference Standards

Job Summary

Seeking a Senior Manager, Reference Standards in a full-time remote role, this position will manage the lifecycle of reference standards and critical reagents, ensuring compliance and operational efficiency in biologics development and commercial operations.

Key responsibilities

• Own and manage the lifecycle of reference standards and critical reagents from receipt and qualification through issuance and retirement
• Review and assess analytical data related to reference standard qualification and stability monitoring
• Author, review, and approve GMP documentation, including SOPs and qualification protocols

Required qualifications

• PhD in Chemistry, Biochemistry, Pharmaceutical Sciences, or related discipline with 3+ years of relevant experience, or MS with 6+ years, or BS with 8+ years
• Strong knowledge of biologics Quality Control and industry best practices for reference standards and critical reagents
• In-depth understanding of cGMP principles and regulatory expectations
• Experience managing reference standard qualification and lifecycle activities in clinical or commercial environments
• Proficiency in authoring GMP documentation and working with CDMOs in a GMP environment