Manager, CMC Drug Substance

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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

• 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

🎯 Requirements

• 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

🏖️ Benefits

• Travel up to 25%