Senior Manager, Reference Standards – Reagents

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Vera Therapeutics, Inc.

WebsiteLinkedInAll Job Openings

201 - 500 employees

🧬 Biotechnology

💊 Pharmaceuticals

Biotechnology • Pharmaceuticals

Vera Therapeutics, Inc. is a clinical-stage biotechnology company focused on developing treatments for immunological kidney diseases that improve patients’ lives. The company is advancing Atacicept through clinical development for IgA nephropathy (IgAN), running Phase 2b and Phase 3 trials, and pursuing programs in lupus nephritis and other immunologic conditions. Headquartered in Brisbane, CA, Vera emphasizes science-driven drug development, patient engagement, and sustainability.

📋 Description

• 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, quality control, or GMP laboratory operations, OR • MS with 6+ years of relevant industry experience, OR BS with 8+ years of relevant industry experience. • Strong knowledge of biologics Quality Control and industry best practices for reference standards, critical reagents, analytical controls, and stability programs. • In-depth understanding and application of cGMP principles, data integrity requirements, and regulatory expectations in the US and internationally. • Experience managing reference standard qualification and lifecycle activities for biologics in clinical and/or commercial environments. • Experience supporting analytical methods across multiple technologies including chromatography, bioassays, and spectroscopy techniques. • Experience authoring and reviewing GMP documentation including protocols, reports, SOPs, deviations, investigations, CAPAs, and regulatory filings. • Experience working with CDMOs and contract testing laboratories in a GMP environment. • Strong technical, organizational, and problem-solving skills with the ability to independently drive complex projects and develop innovative solutions. • Excellent verbal and written communication skills and demonstrated ability to work effectively in a team-oriented environment.

🏖️ Benefits

• Health insurance • Dental insurance • Vision insurance • 401k match • Flexible time off • Paid holidays • Annual performance incentive bonus • New hire equity • Ongoing performance-based equity