Senior Manager, CMC Analytical Sciences

🕒 4 dias atrás

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Sabin Vaccine Institute

SiteLinkedInTodas as Vagas

51 - 200 funcionários

Fundada em 1993

⚕️ Seguro de Saúde

🧬 Biotecnologia

🤝 Sem Fins Lucrativos

💰 $35.000.000 Grant em 2023-01

Healthcare Insurance • Biotechnology • Non-profit

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

• Direct analytical activities conducted by external laboratories and contract development and manufacturing organizations (CDMOs) • Provide expert technical leadership in CMC analytical sciences including development, qualification, validation, and transfer of analytical methods • Collaborate cross-functionally to ensure analytical strategies meet regulatory expectations • Lead and oversee ICH-compliant stability programs including forced degradation studies • Compile, review, and analyze analytical data in support of development programs

🎯 Requisitos

• Bachelor’s degree in biochemistry, chemistry, biology, chemical engineering, or related pharmaceutical science required; advanced degree preferred • 9+ years of experience in biopharmaceutical product development, including management of CMC analytical activities • Experience in vaccines, cell therapy, or gene therapy strongly preferred • Demonstrated experience overseeing CDMOs and/or managing remote external analytical activities • Strong technical expertise in biologics and/or vaccine development • Hands-on experience with analytical techniques such as qPCR/RT-PCR, HPLC, ELISA, mass spectrometry, light scattering, and cell-based potency assays • Proven ability to define and justify Critical Quality Attributes (CQAs) • Experience supporting GMP manufacturing process characterization strongly preferred • In-depth understanding of US and EU CMC regulatory requirements • Comprehensive working knowledge of current Good Manufacturing Practices (cGMPs) • Experience authoring CMC sections for INDs, NDAs, BLAs, and ex-US regulatory submissions • Strong attention to detail with excellent organizational and problem-solving skills • Willingness to travel domestically and internationally as needed

🏖️ Benefícios

• Comprehensive benefits package including medical, dental, and vision coverage • Flexible spending accounts • Flexible vacation and sick leave • Employer-paid life and disability insurance • Observance of 11 federal holidays • End-of-year winter break • Employer-matching 401(k) plan