Process Engineer - Drug Substance

Role: Process Engineer supporting gene therapy Drug Substance manufacturing from clinical to commercial stages. Objectives: ensure technical excellence in manufacturing, process transfer, validation, and facility startup for Adenovector products. Responsibilities: provide end-to-end process engineering support, collaborate across departments (Process Development, QC, QA, Supply Chain, CMOs), oversee process data trending and continuous improvement, author technical reports and protocols, troubleshoot production issues, and assist regulatory documentation. Qualifications: B.Sc or M.Sc in Chemical Engineering, Bioengineering, Biotechnology, or related; 3-4 years biopharma manufacturing experience with process development, technology transfer, and process support; skilled in data analysis, technical report writing, and process optimization. Preferred Skills: experience with viral vectors/vaccines, facility design, operational excellence, and mentoring. HighValue: gene therapy (Adenovector), viral vector manufacturing, process validation, process transfer, regulatory support, cGMP environment, clinical to commercial phases. WorkSetup: not specified; likely on-site with cross-functional collaboration.