Senior Manufacturing Associate, Upstream - 3rd Shift

Description

• Assist in the creation of the Bill of Materials for the upstream process.
• Assist in development and creation of the upstream process.
• Monitor upstream operations (including trouble shooting and diagnosis of instruments, equipment, process, etc.)
• Set-up, prepare, and operate manufacturing equipment/labware/assemblies (includes scaleup, bioreactors, harvest filtration including centrifugation, autoclave/sterilizer, bench top meters (pH/conductivity/osmometer), etc.) in accordance with current good manufacturing practices (cGMP).
• Based on business needs there will be some cross training to support upstream operations (includes filtration skid, chromatography skid, viral filtration skid, TFF skid, Bulk fill, Freeze/Thaw, etc.) in accordance with current good manufacturing practices (cGMP).
• Record and document procedures with detail and accuracy. This includes batch records, training records, logbooks, standard operating procedures (SOPs) and validation protocols.
• Execute quality systems (including critical work orders, document change requests, change control, deviations, corrective action preventative action (CAPA)).
• Create and revise standard operating procedures, batch records, part numbers, specifications, etc.
• Weigh and prepare culture media, feeds, buffers, and solutions.
• Coordination and collaboration of activities with other departments, and with external vendors.
• Sample solutions and perform analytical assays (including cell counts, pH, conductivity, etc.)
• Perform technical training for staff (including hands-on and class-based training)
• Assist CMC team with technical transfer activities.
• Identify and implement equipment and process improvements.
• Maintain clean room work areas (including floors, benches, bioreactors, chromatography skids, etc.) waste disposal, lean manufacturing and good manufacturing practices (GMP)/compliance.

Requirements

• 4 years of college science in Cell Biology, Biochemistry, Chemistry, Biology, with 2 to 4 years of related experience.
• Or 4 to 8 years of experience and/or training, or equivalent combination of education and experience.
• Proficiency of upstream equipment (scaleup, bioreactors, harvest filtration, flow/UV/pH/conductivity/etc. sensors), filtration equipment, solution preparation equipment (laminar air flow hood, agitator mixers, bench top instruments) are essential for this position.
• Attention to detail and accurate record keeping and documentation is mandatory in this position.
• Teamwork and communication are key attributes needed for this position. A collaborative attitude and a positive work ethic are key traits for success.
• Flexible work hours as business requires.