Scientist II
Core
Resolve manufacturing process problems and improve efficiency in a bioprocess manufacturing setting using scientific analysis and problem-solving tools.
Role type
Manufacturing Scientist II
Builds
Bioprocess manufacturing operations for medical devices and pharmaceutical products
Domain
Life Sciences / Bioprocessing / Medical Technology
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP compliance, process troubleshooting, root cause analysis, experimental design, statistical analysis, SOP development, validation support, data interpretation, process optimization
Preferred skills
Flow cytometry, infectious biological sample handling, Minitab or statistical software, value stream mapping
Technologies
MS Office suite, Minitab, laboratory instruments and equipment
Responsibilities
Analyze and resolve manufacturing process issues with minimal guidance; Support Manufacturing and Quality Control investigations; Evaluate production process failures and support NCRs and CAPR; Perform complaint investigations; Assess changes to manufacturing processes and protocols; Collect, analyze, and interpret experimental data; Develop experimental test methods and protocols; Support new product transfer and sustaining projects; Prepare and submit SOPs, BOMs, and routings; Assist validation department in developing protocols and writing reports; Lead continuous improvement activities for process efficiency and waste reduction.
Seniority
Mid-level, hands-on IC
