Principle Process Engineer, Viral Vector Process Characterization and Commercialization

Role: Principal Process Engineer specializing in late-phase process development, validation, and commercialization of viral vector biologics. Objectives include ensuring process robustness, readiness for BLA submissions, and lifecycle management post-approval. Responsibilities: lead or support process characterization, validation studies, and technical oversight across manufacturing operations; author and coordinate CMC sections for regulatory filings; support technology transfer, PPQ, and manufacturing readiness; collaborate with cross-functional teams including Regulatory, Quality, Analytical Sciences, and external CMOs/CDMOs; and contribute to inspection readiness and technical troubleshooting. Qualifications: BS in Chemical/Biochemical Engineering or related with 14+ years (MS with 10+ years, PhD with 7+ years) of relevant experience; proven experience in late-stage biologics process development, validation, and regulatory submission authoring; deep understanding of biologics manufacturing platforms (upstream/downstream/formulation); GMP, validation, and lifecycle management expertise. Preferred: direct viral vector manufacturing experience, prior authorship of approved regulatory submissions, and experience working with CMOs/CDMOs. High-value: biologics, viral vectors, late-stage development (pre-approval), regulatory filings (BLA/MAA), process validation, and manufacturing support. Collaboration involves internal cross-functional teams and external partners. Work setup is not specified, but the role entails technical leadership, with a focus on process excellence in biologics manufacturing.