Specialist Upstream Operations (m/f/d)
Core
Full-time physical presence at the Schachen Biotech site to support GMP manufacturing of early-phase clinical biologics drug substance via upstream operations.
Role type
Specialist Upstream Operations (Manufacturing)
Builds
Early-phase clinical supply for biologics therapies
Domain
Biopharmaceuticals / Biologics Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Upstream processing of biologics, GMP compliance, EHS standards, Process execution (fed-batch), Deviation management, CAPA development, SOP creation, Material management (SAP), Mentoring
Preferred skills
Continuous manufacturing, Automated systems (DeltaV), Electronic batch records (PAS-X), Quality management systems (SAP QM/VeevaVault)
Technologies
SAP, DeltaV, PAS-X, VeevaVault
Responsibilities
Set up and troubleshoot upstream fed-batch processes, Manage process documentation and deviations, Create and update SOPs and master batch records, Perform material management, Mentor junior team members, Participate in sampling and on-call duties
Seniority
Mid-level (2-5 years experience)
