Principal Research Associate, Analytical Development

Role: Analytical Program Lead (APL) partner within Analytical Development, focusing on regulatory execution and scientific support for vaccine programs. Responsibilities: support analytical control strategies, prepare and review regulatory CMC documentation, respond to health-authority queries, coordinate Annual Strain Update activities, maintain trackers for deliverables, synthesize complex analytical data into regulatory narratives, and ensure compliance with GxP and global regulatory standards. Collaborate across cross-functional teams, including Analytical Sciences, Product Characterization, QC, and Regulatory CMC, to facilitate regulatory filings and lifecycle activities. Requirements: MS with 5+ years or BA/BS with 8+ years in biotech/pharma, with expertise in analytical chemistry, biopharma development, and regulatory submissions. Preferred: hands-on experience supporting vaccine analytical development, CMC documentation, and knowledge of global regulatory guidance (FDA, EMA, ICH). High-value specifics: vaccine lifecycle support, regulatory filings, analytical method and stability data, GMP and data integrity adherence. Work setup: 100% onsite with an emphasis on close collaboration and in-person work.