Principal Scientist, Upstream Process Science

Role: Principal Scientist, Upstream Process Sciences, leading process development and characterization for GMP manufacturing of cell and immunotherapy products. Responsibilities include managing and mentoring the upstream process team, developing scalable microbial and cell culture processes (including viral vectors, monoclonal antibodies, and proteins), and supporting process transfer and validation. The role involves designing experiments, optimizing processes, ensuring compliance with quality systems, and collaborating with discovery, analytical, quality, regulatory, and manufacturing teams. Key deliverables include technical protocols, reports, and regulatory submissions. Qualifications: Ph.D. in Life Sciences with 6+ years or MSc with 9+ years or Bachelor’s with 12+ years of biopharma process development or GMP manufacturing experience, specifically in upstream operations. Supervisory experience is preferred. Skills: expertise in microbial and cell culture processes, statistical DOE, process validation, and technical writing; strong communication and collaboration skills; knowledge of biologics, vaccines, or cell/gene therapies is advantageous. Work setup: on-site in Louisville, CO, with flexibility, in a lab and cleanroom environment; travel up to 10%.