Senior Principal Scientist - Process Development
Core
Provide scientific leadership in the development and manufacture of therapeutic proteins using mammalian cell culture, focusing on process characterization and validation for late-stage clinical or commercial biologics programs.
Role type
Senior Principal Scientist (Process Development)
Builds
Therapeutic proteins via mammalian cell culture for late-stage clinical and commercial biologics programs
Domain
Biologics manufacturing / Process Development
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Mammalian cell culture process development, Process characterization (PC), Process validation (PV), BLA-enabling studies, Quality by Design (QbD), Design of Experiments (DoE), Risk-based methodologies, Regulatory compliance, Cross-functional technical leadership
Preferred skills
Experience with USP or DSP, Lifecycle management, Emerging technology evaluation
Technologies
None explicitly listed beyond methodologies
Responsibilities
Lead late-stage process characterization and validation strategy development, Apply data-driven approaches to resolve complex technical challenges, Collaborate with R&D, Manufacturing, and Quality teams, Provide technical guidance to customers and internal stakeholders, Identify and share emerging scientific trends, Support customer interactions through technical presentations
Seniority
Principal, hands-on IC with strategic leadership
