Vice President, Manufacturing

🕒 Julho 27

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SAB BIO

SiteLinkedInTodas as Vagas

51 - 200 funcionários

Fundada em 2014

🧬 Biotecnologia

💊 Farmacêutico

🏥 Saúde

Biotechnology • Pharmaceuticals • Healthcare

A SAB BIO é uma empresa biofarmacêutica em estágio clínico focada no desenvolvimento de terapias multi-específicas e de alta potência de imunoglobulina G humana (hIgG) para tratar e prevenir distúrbios imunológicos e autoimunes, com a missão declarada de redefinir o diagnóstico e tratamento do diabetes tipo 1 (T1D) através de medicamentos modificadores da doença. Fundada em 2014 e listada na Nasdaq (SABS) desde 2021, a SAB BIO utiliza engenharia genética proprietária e tecnologias de anticorpos para gerar candidatos terapêuticos sem depender de doadores humanos ou plasma convalescente. A empresa realizou sete ensaios clínicos envolvendo cerca de 700 indivíduos em diversas áreas terapêuticas, sem relatos de pacientes com doença do soro ou anticorpos anti-fármacos neutralizantes em seu banco de dados de segurança e imunogenicidade. Seu principal candidato, o SAB-142, visa retardar o início e potencialmente prevenir a progressão do estágio 3 do T1D.

Descrição

• Provide strategic, operational, and technical leadership for the company’s manufacturing activities. • Establish scalable, compliant, and cost-effective manufacturing capabilities. • Lead manufacturing network strategy, CDMO management, technology transfer, scale-up, process validation, operational readiness, and reliable commercial supply. • Ensure that manufacturing operations meet global regulatory expectations and maintain a strong culture of safety, quality, compliance, and continuous improvement. • Develop and execute the overall manufacturing strategy supporting late-stage clinical development and commercial launch readiness. • Provide executive leadership and oversight of CDMO partners supporting bulk process intermediates and drug product manufacturing activities. • Oversee technology transfer of manufacturing processes to external partners and support scale-up from development through commercial production. • Ensure successful execution of cGMP manufacturing campaigns supporting clinical supply and future commercial supply.

🎯 Requisitos

• Ph.D. in Chemical Engineering, Biochemistry, Pharmaceutical Sciences, or a related discipline preferred. • Advanced scientific degree strongly preferred. • 15+ years of progressive experience in biologics manufacturing, technical operations, CMC, or pharmaceutical operations. • Significant experience leading GMP manufacturing operations and managing outsourced biologics manufacturing through CDMOs. • Demonstrated success supporting late-stage clinical programs. • Experience leading technology transfer, process validation, scale-up, and commercial readiness for immunoglobulin-based or protein-based products. • Expertise in plasma fractionation, plasma-derived therapeutics, high-purity protein purification, or analogous large-scale separation and purification processes is desired. • Proven track record contributing to global regulatory filings and CMC documentation. • Experience supporting BLA submissions, pre-approval inspections, regulatory inspections, and commercial launch readiness activities strongly preferred. • Strong experience building and leading high-performing technical teams.

🏖️ Benefícios

• Health insurance • Retirement plans • Paid time off • Flexible work arrangements • Professional development