PROCESS KNOWLEDGE:
• Understood process theory and equipment operation.
• Learned biopharmaceutical manufacturing processes including mammalian cell culture, depth filtration, tangential flow filtration, column chromatography, protein purification and the formulation of bulk drug substance.
• Supported initiatives for process optimization.
• Identified and elevated processing issues and support solutions.
• Demonstrated proficiency with automation systems (LIMS, MES, PI).
TECHNICAL DOCUMENTATION:
• Provided feedback and/or suggested changes to operational procedures.
• Assisted in the incorporation of new technologies, practices and standards into procedures.
• Wrote and reviewed process documents.
QUALITY AND COMPLIANCE:
• Understood cGMPs as related to Commercial Operations.
• Utilized Quality systems (Deviations, CAPAs, Change Requests, Action/Alert Reports).
BUSINESS:
• Participated on projects and contributed to outcomes.
• Support new business systems (Track wise, ERP).