Senior Specialist, Bioprocess & Technical Engineering
Core
Lead facility-fit assessments, develop process mass balances and capacity models, and drive technology identification for biologics manufacturing to ensure facilities are ready for new products and scale-up.
Role type
Senior Specialist, Bioprocess & Technical Engineering (Biologics Manufacturing)
Builds
Manufacturing readiness strategies, capacity models, and platform technology standards for biologics drug substance.
Domain
Biopharmaceuticals / Biologics Manufacturing
Required skills
Biologics drug substance manufacturing, Facility design, Process engineering, Commercial manufacturing support, GMP environments, Technology transfer, Mass balance modeling, Capacity planning, Equipment selection, Digital engineering tools
Preferred skills
Monoclonal antibody manufacturing, Upstream/downstream process engineering, PPQ, Lifecycle management, Lean Manufacturing, Six Sigma, Global regulatory requirements
Technologies
GMP, PPQ, Lean Manufacturing, Six Sigma
Responsibilities
Lead facility-fit and manufacturing readiness assessments, Develop process mass balances and capacity models, Drive technology identification and platform alignment, Establish platform technology standards, Support deployment of digital engineering tools, Provide technical leadership and mentorship, Support cross-functional technical assessments and investigations, Drive continuous improvement and innovation, Shape future manufacturing network strategies, Foster engineering excellence culture
Seniority
Senior, hands-on IC with leadership responsibilities
