Senior Manufacturing Associate-Downstream

Company: RPMGlobal
Location: Berkeley
Posted on: May 24, 2023

Job Description:

The Senior Manufacturing Associate will have the opportunity to coordinate and collaborate with other cross-functional departments, including Quality, Facilities, Procurement, etc. This position requires independent execution of quality systems (includes initiation of critical work orders, change requests, deviations, corrective action preventative action (CAPA)). There will be times when work schedules change to accommodate the processing schedule. Contribution and participation will be required for additional assignments and projects including report writing, data analysis, experiment/validation execution, data compilation/summarization, etc. The Senior Manufacturing Associate will assist with planning and scheduling of the upstream/downstream operations. The Senior Manufacturing Associate will have more engagement and responsibility for continuous process improvement.
Roles and Responsibilities:

• 
  
• Assist CMC team with technical transfer activities.
  
• Assist in the creation of the Bill of Materials for the upstream/downstream process.
  
• Assist in development and creation of the upstream/downstream process.
  
• Monitor fermentation and purification operations (including trouble shooting and diagnosis of instruments, equipment, process, etc.)
  
• Set-up, prepare, and operate manufacturing equipment/labware/assemblies (includes filtration skid, chromatography skid, fermenter, autoclave/sterilizer, bench top meters (pH/conductivity/osmometer), 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, change requests, engineering change, deviations, corrective action preventative action (CAPA)).
  
• Create and revise standard operating procedures, batch records, specifications, etc.
  
• Weigh and prepare culture media, buffers, and solutions.
  
• Coordination and collaboration of activities with other departments, and with vendors
  
• Sample solutions and perform analytical assays (including cell counts, pH, conductivity, etc.)
  
• Perform technical training (including hands-on and class-based training)
  
• Identify and implement equipment and process improvements.
  
• Plant cleaning (including floors, benches, bioreactors, equipment, etc.) waste disposal, lean manufacturing and good manufacturing practices (GMP)/compliance.
  
  Requirements:
  
  • 
    
  • Knowledge of downstream equipment (columns, skids, flow/UV/pH/conductivity/etc. sensors), filtration equipment, solution preparation equipment (laminar air flow hood, agitator mixers, bench top meters) are essential for this position.
    
  • Knowledge of upstream equipment (laminar air flow hood, shake flask scale-up, single use bioreactors and control software, and analytical instruments for cell count, osmolality, and metabolites) are essential for this position.
    
  • Attention to detail and accuracy for record keeping and documentation is mandatory in this position
    
  • Teamwork and communication are key attributes needed for this position, as this role will be part of a small team within manufacturing. A collaborative attitude and a positive work ethic are key traits for success.
    
    Education Requirements:
    
    • 
      
    • 2 years of college science in Cell Biology, Biochemistry, Chemistry, Biology, with 2 to4 years of related experience
      
    • Or 4 to8 years of experience and/or training, or equivalent combination of education and experience.
      
      The targeted salary range for this position is $60,000 - $89,100 per year. Agenus is making a good faith effort to be transparent and accurate around our hiring ranges. The salary offered is commensurate with Agenus's compensation philosophy and considers factors including, but not limited to, education, training, experience, external market conditions, critical needs of the role, and internal equity.
      

Keywords: RPMGlobal, Berkeley , Senior Manufacturing Associate-Downstream, Other , Berkeley, California