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Senior Manager, Reference Standards & Reagents

Vera Therapeutics, Inc.
CompanyVera Therapeutics, Inc.
CategoryOperations & Admin
LocationRemote
RemoteRemote
EmploymentNot stated
LevelSenior
SalaryNot stated by the employer
Posted17 Jun 2026
Last verified4 Aug 2026
SourceEmployer ATS (greenhouse)
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Description
Vera Therapeutics is a commercial-stage biotechnology company focused on the pursuit of truth in science to transform medicine in autoimmune disease, starting with the kidney. Vera Therapeutics’ flagship commercial product is TRUTAKNATM (atacicept-vymj), a B-cell activating factor (BAFF) and A proliferation-inducing ligand  ( APRIL) inhibitor. Vera Therapeutics is evaluating multiple diseases where the reduction of autoantibodies through inhibition of BAFF and APRIL may prove clinically meaningful. Vera Therapeutics was founded in 2016 and is based in Brisbane, California. To learn more, visit  www.veratx.com .   At Vera, our values are the cornerstone of our culture and guide how we work together every day. We lead with empathy, act with an owner’s mindset, demand clarity, work without fences, and execute with urgency because patients are counting on us. From how we hire and develop our people to how we advance rigorous science, we are building a team committed to transforming medicine in autoimmune diseases, starting with the kidney.      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. 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
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