Principal Engineer, MS&T
Core
Lead upstream gene therapy manufacturing processes, troubleshoot complex scientific challenges, and drive continuous improvement for life-changing therapies.
Role type
Principal Engineer, MS&T (Upstream Manufacturing)
Builds
Gene therapy products via upstream manufacturing processes
Domain
Biopharmaceuticals / Gene Therapy / Upstream Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Mammalian cell culture, Bioreactor systems (suspension and adherent), Upstream processing, Triple transfection, GMP requirements, Process validation, Technical troubleshooting, Technology transfer, Operational excellence
Preferred skills
Applied statistics, Data analytics, Change controls, Regulatory compliance, Process control
Technologies
Bioreactor systems, Upstream processing platforms
Responsibilities
Provide technical leadership for complex scientific investigations and regulatory submissions; Lead analysis of process verification data to drive continuous improvement; Troubleshoot and resolve complex manufacturing issues across internal operations and external partners; Mentor staff in upstream processing and complex platforms; Lead product technology transfers into GMP environments; Partner cross-functionally to ensure reliable production execution; Monitor critical quality attributes and process parameters; Define and implement process improvements; Support startup, qualification, and lifecycle management of manufacturing equipment; Author and approve technical documentation for regulatory defensibility; Drive operational excellence and regulatory compliance initiatives
Seniority
Principal, scientific and technical leader
