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Senior Manufacturing Associate, Upstream - 3rd Shift

icon building Company : Zylidac Bio Llc
icon briefcase Job Type : Full Time
icon geo-alt Emeryville, United States

Job Description - Senior Manufacturing Associate, Upstream - 3rd Shift



Full-time


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.

Salary Description

35.00 - 50.00

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