Principal Scientist, Manufacturing Technology
Core
Lead commercial technical transfers, process validations, and project portfolios for biologics drug substance manufacturing to ensure cGMP compliance and regulatory approval.
Role type
Principal Scientist, Manufacturing Technology
Builds
Commercial biologics drug substance products
Domain
Biopharmaceuticals / Biologics Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Biologics process design and validation, Technology transfer leadership, Quality by Design (QbD), Regulatory package authoring (CMC), Stakeholder management, Project management, Process control fundamentals
Preferred skills
CMC filing experience, Global regulatory requirements knowledge, Project management tools proficiency
Technologies
cGMP systems, Quality management systems, Project management tools
Responsibilities
Lead complex technical transfers for biologics drug substance; Influence technical direction across media/buffer, cell culture, purification, and formulation; Drive process validation protocols and reports; Support site regulatory inspections (PAI); Manage project portfolio for technical transfer and post-approval changes; Collaborate with cross-functional teams (Quality, Engineering, Operations)
Seniority
Principal, hands-on IC with strategic oversight
