Senior Manager, Reference Standards & Reagents

Vera Therapeutics is a biotechnology company dedicated to developing innovative treatments for serious immunological diseases. We are seeking a Senior Manager, Reference Standards & Reagents to join our collaborative CMC team and provide strategic leadership for the lifecycle management of critical materials supporting our biologics pipeline.

Key responsibilities

• Manage the full lifecycle of reference standards and critical reagents, from qualification and inventory control to requalification and retirement.
• Review and assess analytical data related to standard qualification, stability monitoring, and assay performance.
• Author and approve GMP documentation, including SOPs, protocols, reports, deviations, and CAPAs.
• Collaborate with Analytical Development, Quality Assurance, and external CDMOs to ensure compliant analytical testing and product release.
• Support regulatory filings and health authority inspections by maintaining inspection-ready records and technical documentation.

Requirements

• PhD with 3+ years, MS with 6+ years, or BS with 8+ years of experience in biologics analytical development or GMP quality control.
• Strong knowledge of cGMP principles, data integrity requirements, and industry best practices for reference standards and stability programs.
• Proven experience managing reference standard qualification and lifecycle activities in clinical or commercial environments.
• Proficiency in supporting analytical methods, including chromatography, bioassays, and spectroscopy.
• Excellent problem-solving skills and the ability to drive complex projects within a team-oriented environment.

What we offer

• Opportunity to contribute to the development of life-changing therapies for patients with immunological diseases.
• Comprehensive total compensation package including performance-based bonuses and equity.
• Robust benefits program featuring medical, dental, and vision insurance, 401k matching, and flexible time off.
• A collaborative, fast-paced work environment focused on innovation and scientific excellence.