Senior Manager, CMC Analytical Sciences

🕒 June 12

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Sabin Vaccine Institute

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 1993

🏥 Healthcare

💼 Consulting

🍽️ Food & Beverage

💰 $35M Grant on 2023-01

Healthcare • Consulting • Food & Beverage

Sabin Vaccine Institute is dedicated to improving global health by ensuring access to life-saving vaccines. The institute focuses on research and development of new vaccines for some of the world’s most pressing diseases, including cholera, HPV, malaria, Marburg, and Ebola. Through innovative programs and partnerships, Sabin aims to enhance immunization capacities and vaccine acceptance within communities, ultimately striving to make vaccination accessible to all, especially vulnerable populations.

📋 Description

• 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

🎯 Requirements

• 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

🏖️ Benefits

• 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