Drug Substance Manufacturing Associate (Hiring Event)

Essential Duties & Responsibilities

Will be assigned to the daily operations, working with:

• Weighing and dispensing of material
• Filtration systems
• Inoculation of mammalian or cytokines cells
• Fermentation and harvest
• Chromatography columns and TFF operations
• Responsible for in-process testing, such as: pH, Conductivity, Spectrophotometer, Osmometer, Cell count, etc.
• Prepares media and buffer solutions.
• Completes Batch Records and other cGMP documentation accurately and in a timely manner.
• Remove and dispose soiled materials from the manufacturing area.
• Will assure that the manufacturing areas are maintained within the required conditions for clean room manufacturing.
• Will report all nonconformance or events that arise during the shift to the Supervisor.
• Assists in the transfer of technology from Process Development to cGMP Manufacturing.
• Complies with all safety, cGMP and Company policies, practices and procedures.
• Performs other functions as required or assigned
• Complies with all company policies and standards

Education:

• Associate degree or higher in Biology, Chemistry, Biotechnology or related preferred
• An equivalent of 1+ years of biologics and/or pharmaceutical industry experience required