Senior Manager, Reference Standards & Reagents

Responsibilities

• Own and manage the lifecycle of reference standards and critical reagents, including primary, working, interim, in-house, compendial, and assay control/standards from receipt and qualification through issuance, requalification, and retirement.
• Review and assess analytical data associated with reference standard qualification, stability monitoring, trending, and assay performance.
• Author, review, and approve GMP documentation including SOPs, qualification/requalification protocols and reports, CoAs/CoCs, deviations, CAPAs, change controls, and technical reports.
• Establish and maintain strategies for qualification, characterization, bridging, and requalification of reference standards and critical reagents to support analytical testing and product release.
• Ensure uninterrupted supply, inventory control, storage, labeling, distribution, and tracking of qualified reference standards and critical reagents for GMP operations.
• Define and oversee appropriate storage, handling, shipping, and environmental monitoring requirements, including management of temperature excursions and investigations.
• Collaborate with Analytical Development, QC, and external laboratories to support method qualification, validation, comparability assessments, and commercial specification setting activities.
• Maintain accurate and inspection-ready records within electronic systems.
• Support investigations related to deviations, OOS/OOT results, atypical trends, and risk assessments associated with reference standards and critical reagents.
• Partner with Regulatory Affairs to support regulatory filings, responses to health authority questions, and preparation of analytical sections related to reference standards and assay controls.
• Support internal audits, external inspections, and health authority inspections by ensuring inspection readiness of documentation and systems.
• Manage activities at CDMOs and contract testing laboratories related to reference standard qualification, inventory management, and analytical support.
• Drive continuous improvement initiatives to enhance operational efficiency, compliance, scalability, and business continuity for reference standard and reagent management processes.

Requirements

• PhD in Chemistry, Biochemistry, Pharmaceutical Sciences, or related discipline with 3+ years of experience in biologics analytical development, qu

Benefits

Additional Information

Vera Therapeutics is a biotechnology company focused on developing treatments for serious immunological diseases. Vera Therapeutics' mission is to advance treatments that target the source of disease in order to change the standard of care for patients. Vera Therapeutics' lead product candidate is atacicept, a fusion protein self-administered at home as a subcutaneous once weekly injection that blocks both B-cell Activating Factor (BAFF) and A Proliferation-Inducing Ligand (APRIL), which stimulate B cells to produce autoantibodies contributing to certain autoimmune diseases, including IgA nephropathy (IgAN) and lupus nephritis. Beyond IgAN, Vera Therapeutics is evaluating additional diseases where the reduction of autoantibodies by atacicept may prove clinically meaningful. In addition, Vera Therapeutics holds an exclusive license agreement with Stanford University for a novel, next generation fusion protein targeting BAFF and APRIL, known as VT-109, with wide therapeutic potential across the spectrum of B-cell-mediated diseases. Vera Therapeutics is also evaluating the development of MAU868, a monoclonal antibody designed to neutralize infection with BK virus, which can have devastating consequences in kidney transplant recipients. Vera Therapeutics retains all global developmental and commercial rights to atacicept, VT-109, and MAU868. For more information, please visit www.veratx.com . Our values are the cornerstone of our culture. Our values inspire us every day and guide everything we do-from how we hire great people, to advancing our mission together, to achieving our ultimate goal to improve medical treatment for patients suffering from immunological diseases. Position Summary: We are seeking a Senior Manager, Reference Standards & Reagents to join an experienced, fast-paced, and collaborative CMC team. This role will report to the Associate Director or Director, Quality Control and will provide strategic and operational leadership for lifecycle management of reference standards and critical reagents supporting biologics development and commercial operations. The successful candidate will partner cross-functionally with Analytical Sciences, Quality Assurance, Regulatory Affairs, Manufacturing, Supply Chain, and external CDMOs/CTLs to ensure compliant qualification, inventory management, distribution, lifecycle oversight of reference standards and critical reagents used in GMP testing, and the associated tracking and trending. This role will support late-stage development, regulatory submissions, commercial activities and inspection preparedness.

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