• Develop and deliver phase-appropriate product understanding and control strategies using QbD framework and risk assessment • Support manufacture of clinical and commercial GMP DS throughout product lifecycle, including tech transfer, campaign analysis, and diagnostics • Author and review technical reports, master and executed batch records, working across internal team and with CDMO partners • Work closely with CDMO partners, providing technical oversight (including onsite Person in Plant support when required), and taking the lead in supporting investigations and resolving deviations • Analyze process and manufacturing data to understand and optimize process performance • Develop process characterization and PPQ strategies and documentation • Support regulatory activities including submissions and site inspections from preparation through execution • Liaise with DP, device development, and clinical supply chain as needed to ensure seamless end to end product delivery and robustness • Develop and maintain cost of good models that describe process and enable sensitivity analyses for process improvements • Collaborate closely with colleagues to ensure a seamless, highly integrated TechOps team • Author and review internal procedures, reports, and presentations, as needed