Associate Principal Scientist, Engineering - Vaccine, Sterile Drug Product Commercialization

Role: Associate Principal Scientist in Vaccine Sterile Drug Product Commercialization, focusing on biologics pipeline advancement and late-stage process development. Responsibilities include leading cross-functional vaccine drug product teams, ensuring process development aligns with manufacturing robustness, managing scale-up, tech transfer, process validation, and regulatory submissions. The role involves guiding process characterization, validation activities, and supporting registration efforts such as PPQ and stability studies, with a focus on vaccines like conjugates, VLPs, and adjuvants. It requires technical expertise in sterile fill-finish operations, process transfer, and optimization for large molecules, along with experience in cGMP compliance, ICH norms, and regulatory strategy influence. The position also involves mentorship, strategic initiatives, and fostering a culture of innovation. Qualifications: Bachelor's, Master's, or Ph.D. in Chemical Engineering, Biochemistry, Microbiology, or related fields, with 4-10+ years of relevant experience in vaccine or biologics process development, scale-up, and regulatory submissions. Preferred skills include statistical methods for process analysis, data analytics, and digital applications. The role entails up to 25% travel, hybrid work setup, and reports to senior leadership within the manufacturing division, with a salary range of $142,400 to $224,100.