Senior Manager, CMC Analytical Sciences

Position Title: Senior Manager, CMC Analytical Sciences

Reports to: Director, Chemistry, Manufacturing & Controls (CMC) Analytical Sciences

Location: Remote Worker, US Only

Why Sabin:

Our mission is to make vaccines more accessible, enable innovation and expand immunization across the globe. We seek a future free from vaccine-preventable diseases. We are an innovative, collaborative, and engaged team that values accountability, teamwork, partnership and driving impact. We are vaccine champions improving lives through immunization. Sabin staff, management and the Board of Trustees are committed to ensuring that fairness, integrity, and opportunity remain at the core of how we operate.

Position Summary:

The Senior Manager, CMC Analytical Sciences is responsible for directing analytical activities conducted by external laboratories and contract development and manufacturing organizations (CDMOs) supporting Sabin’s pipeline. This role provides expert technical leadership in CMC analytical sciences, including the development, qualification, validation, and transfer of analytical methods, as well as stability program design and execution.

The individual will collaborate cross-functionally within Sabin to ensure analytical strategies and deliverables meet current regulatory expectations and support timely advancement of development programs.

Responsibilities:

• Lead the development, qualification, validation, and transfer of analytical methods (e.g., potency, purity, identity, and product-related impurities) for vaccine drug substance and drug product at Sabin’s CDMOs and external laboratories.
• Provide technical oversight and troubleshooting of analytical methods, including SME support for investigation of OOS (Out-of-Specification) and OOT (Out-of-Trend) results, deviations, CAPAs, and change controls.
• Author and review analytical and quality sections of global regulatory submissions (e.g., IND, IMPD, BLA, MAA, including Module 3 CTD sections).
• Provide analytical guidance for specification setting, CQA identification and justification, and physicochemical and biological characterization strategies.
• Partner cross-functionally across CMC to define in-process controls, release specifications, and comparability strategies to support process changes.
• Design and oversee ICH-compliant stability programs (e.g., ICH Q5), including forced degradation studies, real-time and accelerated testing, and shelf-life determination; support data compilation, review, and interpretation.
• Author analytical SOPs, templates, and guidance documents as needed.
• Compile, review, and analyze analytical data in support of development programs as required.
• Oversee the management of reference standards and sample inventories, as needed.