Manager MS&T Biologics
Core
Lead lifecycle management of biologics manufacturing processes (fermentation, purification, formulation, aseptic processing) to ensure product quality, regulatory compliance, and patient safety.
Role type
Manager, Manufacturing Science & Technology (Biologics)
Builds
Commercial manufacturing operations for biologics drug substance and drug product
Domain
Biopharmaceuticals / Biologics Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
biologics manufacturing process expertise, GMP-regulated environment knowledge, process validation, technology transfer, scale-up, continuous process verification, troubleshooting, root cause analysis, team leadership, cross-functional stakeholder management
Preferred skills
aseptic manufacturing, sterile production, toxins, advanced biologics manufacturing technologies
Technologies
fermentation, purification, formulation, aseptic processing, filling
Responsibilities
Provide leadership and technical oversight for biologics drug substance and drug product manufacturing processes; lead team in supporting commercial manufacturing operations and troubleshooting complex technical challenges; drive lifecycle management activities including process validation, CPV, process trending, optimization, and technology transfers; oversee validation strategies and qualification activities ensuring compliance with EU GMP, FDA, and ICH guidelines; build, develop, and coach a high-performing team; act as key cross-functional partner facilitating alignment across Manufacturing, Quality, Engineering, Regulatory Affairs, and Supply Chain
Seniority
Manager, hands-on technical leader with people management responsibilities