Process Expert, Drug Product 80-100%
Core
Lead technical troubleshooting and process improvements on an aseptic filling and lyophilization line for antibody drug conjugate (ADC) manufacturing.
Role type
Process Expert (Drug Product)
Builds
Aseptic filling and lyophilization lines for ADC therapies
Domain
Biopharmaceutical manufacturing (ADC)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
aseptic filling, aseptic manufacturing, GMP environment, lyophilization processes, cleanroom management, technical troubleshooting, process qualification
Preferred skills
equipment qualification, lyophilization processes
Technologies
aseptic filling lines, lyophilization equipment
Responsibilities
Lead technical troubleshooting on the production line, drive process improvements, coordinate line qualification, establish cleanroom management practices, manage deviations and technical changes
Seniority
Mid-Senior, hands-on IC