MSAT Technical Lead - Drug Substance - Biologics
Core
Technical Lead responsible for Drug Substance (DS) Biologics manufacturing, validation, and lifecycle management for Sobi's clinical and commercial products.
Role type
Senior IC Technical Lead (Biologics Manufacturing)
Builds
Validated manufacturing processes and analytical testing capabilities for biologics products
Domain
Pharmaceutical manufacturing (Biologics/DS)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
DS Biologics manufacturing expertise, Upstream Manufacturing (Cell banking, Mammalian Cell culture), regulatory guidelines knowledge, cross-functional collaboration, process validation, scale-down modeling, contract manufacturer evaluation
Preferred skills
Clinical manufacturing experience, bacterial fermentation, CMC development, technology transfer, process innovation
Technologies
Mammalian Cell culture, bacterial fermentation, scale-down models
Responsibilities
Lead DS Biologics validation projects, execute manufacturing process improvements, manage technology transfers to external manufacturers, review and approve SOPs and manufacturing instructions, support registration files and health authority requests, oversee process components of product transfers and scale-up activities
Seniority
Senior, hands-on IC