• Guide process development of protein production from lab-scale to tech transfer and GMP manufacture at CDMOs (including onsite support when required, such as Person in Plant, inspection support, etc.) • Analyze process and manufacturing data to understand and optimize process performance • Troubleshoot processes to identify root causes, propose corrective actions, and support resolution of deviations • Review and approve master and executed batch records; assist with investigations • Author and review internal procedures, reports, and presentations • Develop process characterization and validation strategies and documentation • Liaise with DP, device development, and clinical supply chain as needed to ensure seamless end to end product delivery and robustness • Collaborate cross-functionally with Regulatory to author and support regulatory submissions (IND, IMPD, amendments, IB, BLA, etc.) • Develop phase-appropriate product understanding and control strategies using QbD framework • Create late-phase development strategy to support potential commercialization • Collaborate closely with colleagues to ensure a seamless, highly integrated TechOps team • Along with other TechOps team members, help shape goals and strategic vision for the TechOps organization