- Supporting experimental design, execution, data analysis and interpretation.
- Interpreting trends observed in commercial process monitoring (e.g., proactive process analysis (PPA), continued process verification (CPV), statistical process control (SPC) multivariate analyses (MVDA)), and for further technical investigations and process changes that seek to drive improvements to yield and/or robustness.
- Supporting deviation management.
- Supporting change control prioritization and implementation.
- Authoring and reviewing of batch documentation, technical reports and global regulatory submissions.
- Supporting multidisciplinary teams (manufacturing science and technology, quality, analytics, regulatory) for process improvement and troubleshooting with end-to-end product focus.
- Experience with upstream cell culture and/or downstream purification of biological molecules.
- Experience with technology transfer, regulatory filing, and commercial drug substance manufacturing of biologics is a plus.
- Bachelor's degree (or higher) in Biological Sciences/Chemical Engineering/Biological Engineering/Chemistry (or PhD without industry experience)
