Senior Manager, Reference Standards – Reagents

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Vera Therapeutics, Inc.

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201 - 500 funcionários

🧬 Biotecnologia

💊 Farmacêutico

Biotechnology • Pharmaceuticals

Vera Therapeutics, Inc. é uma empresa de biotecnologia em estágio clínico focada no desenvolvimento de tratamentos para doenças renais imunológicas que melhorem a vida dos pacientes. A empresa está avançando com o Atacicept através do desenvolvimento clínico para nefropatia por IgA (IgAN), conduzindo testes de Fase 2b e Fase 3, e perseguindo programas em nefrite lúpica e outras condições imunológicas. Com sede em Brisbane, CA, a Vera enfatiza o desenvolvimento de medicamentos orientado pela ciência, o engajamento com os pacientes e a sustentabilidade.

Descrição

• 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.

🎯 Requisitos

• 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.

🏖️ Benefícios

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