Drug Substance Manufacturing Associate

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 of 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

• Soft Skills: Ability to learn quickly and ability to work in a fast-paced environment
• Nice to Haves: Plus to have similar industry experience - chromatography column and bioreactor experience