Manager, CMC Drug Substance

🕒 Agosto 7

🇺🇸 Estados Unidos – Remoto (EUA)

💵 $109.000 - $130.000 / ano

⏰ Tempo Integral

🟠 Sênior

🔴 Especialista

👔 Gerente

👻 Score fantasma 3%

O que significa: quão provável esta vaga está aberta sem contratação ativa.Como ler: 60% ou mais significa que achamos que é uma vaga fantasma. Pontuações mais baixas preocupam menos.Como pontuamos: tempo em aberto, republicações, vagas abertas vs tamanho do time, rapidez para fechar vagas, e se o salário está divulgado.Observação: é uma estimativa de dados públicos, não um julgamento da empresa. Vagas reais podem ter pontuação alta, então use como uma dica, não como um fato.

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Sabin Vaccine Institute

SiteLinkedInTodas as Vagas

51 - 200 funcionários

Fundada em 1993

🏥 Saúde

💼 Consultoria

🍽️ Alimentos e Bebidas

💰 $35.000.000 Grant em 2023-01

Healthcare • Consulting • Food & Beverage

O Instituto de Vacinas Sabin se dedica a melhorar a saúde global, garantindo o acesso a vacinas que salvam vidas. O instituto foca em pesquisa e desenvolvimento de novas vacinas para algumas das doenças mais urgentes do mundo, incluindo cólera, HPV, malária, Marburg e Ebola. Através de programas e parcerias inovadoras, a Sabin busca melhorar as capacidades de imunização e a aceitação de vacinas dentro das comunidades, esforçando-se para tornar a vacinação acessível a todos, especialmente às populações vulneráveis.

Descrição

• Support planning, coordination, and execution of vaccine development programs from late-stage clinical development through regulatory submission and commercial supply • Support site selection and onboarding of a new Drug Substance Site • Lead technology transfer of a Phase 3 vaccine manufacturing process to external Drug Substance manufacturing partners • Execute technology transfer strategies, project plans, governance structures, and risk mitigation plans • Lead process characterization, comparability assessments, scale-up/scale-down studies, and process validation activities • Develop and maintain the Drug Substance process control strategy, including CPP identification, cIPC definition, and CPV strategy contributions • Author, review, and approve CMC technical documentation and regulatory submission content • Manage technical deliverables, timelines, risks, and cross-functional dependencies • Ensure compliance with cGMP, regulatory expectations, quality standards, and organizational procedures • Contribute to funding proposals, grant reporting, and strategic planning to advance vaccine access and equity

🎯 Requisitos

• Bachelor’s degree in biochemistry, chemistry, biology, chemical engineering, or related pharmaceutical science • Minimum of 7+ years of experience in biopharmaceutical CMC, manufacturing, process development, and technology transfer • Experience in biopharmaceutical manufacturing, MS&T, and/or process development environments • Hands-on experience with mammalian or viral cell culture, upstream and downstream processing, and purification operations • Experience with chromatography, filtration/ultrafiltration, and viral clearance • Prior technology transfer experience, including site-to-site, scale-up, or CDMO transfers • Experience with adenovirus-vectored vaccines or other viral vector platforms is strongly preferred; comparable complex biologics manufacturing experience considered • Strong analytical, problem-solving, organizational, communication, and interpersonal skills • Direct experience in cGMP-regulated environments, including non-conformance investigations, root cause analysis, change control, and CAPA implementation • Working knowledge of ICH guidelines and global regulatory requirements, including FDA, EMA, and MHRA • Experience supporting late-stage development programs, regulatory submissions such as BLA/NDA, and commercial supply activities • Experience working with external manufacturing partners • Commitment to health equity and improving immunization access in underserved populations • Subject to a criminal background investigation • Request for three professional references • Verification of education/degrees

🏖️ Benefícios

• Travel up to 25%