Associate, Manufacturing (Night Shift)

Key Responsibilities

• Understanding of process theory and equipment operation
• Ability to learn and operate in biopharmaceutical manufacturing processes including cell culture, cell production and protein harvest, depth filtration, tangential flow filtration, column chromatography, protein purification and formulation of bulk drug substance
• Perform all aspects with a broad understanding of scientific, compliance, and technical components
• Support initiatives for process optimization
• Identify and elevate processing issues and support solutions
• Demonstrated experience with automation systems (LIMS, MES, PI, etc.)

Technical Documentation

• Provide feedback and/or suggested changes to operational procedures
• Absorb and incorporate new technologies, practices and standards into procedures
• Capable of writing and reviewing process documents

Quality and Compliance

• Understanding of cGMPs as related to Clinical and/or Commercial Operations
• Utilize Quality systems (Deviations, CAPAs, Change Requests, Action/Alert Reports, etc.)

Business

• 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