Manufacturing Associate
PROCESS KNOWLEDGE:
- Understanding of process theory and equipment operation
- Ability to learn biopharmaceutical manufacturing processes including mammalian cell culture, depth filtration, tangential flow filtration, column chromatography, protein purification and formulation of bulk drug substance
- Support initiatives for process optimization
- Identify and elevate processing issues and support solutions
- Demonstrated proficiency Gain experience with automation systems (LIMS, MES, PI, etc.)
- Provide feedback and/or suggested changes to operational procedures
- Assist in the incorporation of new technologies, practices and standards into procedures
- Capable of writing and reviewing process documents
- Understanding of cGMPs as related to Commercial Operations
- Ability to utilize Quality systems (Deviations, CAPAs, Change Requests, Action/Alert Reports, etc.)
- Ability to participate on projects and contribute to outcomes
- Capability to learn and support new business systems (Track wise, ERP, etc.)
- Support trending of defined department metrics
- TECHNICAL DOCUMENTATION
- METRICS
- ERP
- MANUFACTURING PROCESSES
- LIMS
- FILTRATION
- COLUMN CHROMATOGRAPHY
- CELL CULTURE
- PROTEIN PURIFICATION
- CGMPS
- OPERATIONS
- BIOPHARMACEUTICAL
- ENTERPRISE RESOURCE PLANNING
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