Scientist, Viral Vector Process Development (Downstream)

Role: Scientist, Viral Vector Process Development (Downstream) at AstraZeneca, focusing on scalable purification processes for Lentiviral Vectors (LVV) in cell therapy applications. Responsibilities: design, execute, and optimize downstream purification steps—including clarification, chromatography, UF/DF, sterile filtration, and formulation—targeting yield, purity, potency, and process robustness; perform process characterization and data analysis to define CPPs/CMAs and establish control strategies; support scale-up, tech transfer, and implementation at clinical and commercial scales; evaluate innovative technologies for continuous improvement; author regulatory documents and ensure cGMP compliance; collaborate closely with upstream, analytical, manufacturing, and quality teams. Qualifications: Ph.D. in Chemical/Biochemical Engineering, Biotechnology, or related field with 0-2 years (Ph.D.) or M.S. with 4-6 years industry experience; hands-on development experience with viral vectors or biologics, familiar with clinical and commercial scale considerations; proficiency in downstream unit operations and understanding of viral impurity profiles; knowledge of QbD, DOE, and risk assessment tools; working knowledge of GMP and familiarity with FDA/EMA guidance for gene and cell therapy. Preferred: experience scaling LVV processes, supporting tech transfer, use of PAT/digital tools, and evaluating next-gen purification technologies. Location: Gaithersburg, MD, with some in-person collaboration. The role emphasizes cross-functional teamwork within a regulated biopharma setting, supporting AstraZeneca’s cell therapy portfolio.