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Process Development Associate - 3rd Shift (186335)San DiegoCalifornia.

Process Development Associate - 3rd Shift (186335)

San Diego | California | United States | 92121

Process Development Associate II (PDA II) - San Diego Pilot Plant 

Job Summary: 
Under minimal supervision design and carry out fermentation /recovery experiments, recording data, maintenance/housekeeping and troubleshooting. 

Job Functions: 

1. Carry out fermentation/recovery experiments 
• Read SOP s (if not clear, discuss with a senior PDA/scientist). Update SOP based on discussion. 
• Prep various types of media: Add chemicals, Adjust to correct volume according to SOP. 
• Sterilize medium/solutions using autoclave. 
• Aseptically inoculate seed flasks and place into incubator shaker according to SOP. 
• Prepare fermentors /recovery equipment for SIP or CIP sequences. 
• Calibrate probes according to SOPs. 
• Set up fermentation/recovery parameters according to SOP using HMI or Delta V interface. 
• Set up fermentors/recovery equipment-hook up all external feed bottles, adjust pH and bias, add necessary ingredients according to SOP. 
• Check the inoculum for contamination using microscopy and plating. 
• Inoculate ferment\ors - transfer seed into inoculation bottle and add to tank aseptically, start fermentation process. 
• Sample fermentors/recovery processes and perform analysis according to SOPs. 
• Prepare samples for analysis performed by external groups. 
• Adjust parameters according to SOP. 
• Perform aseptic techniques including operations utilizing a laminar flow hood. 
• Ensure identified problems are communicated to Shift Supervisor 
and/or scientists. 
• Under direction of a scientist design and carry out experiments, schedule analytical support, assist in data analysis, and present results. (PDA II) 
• Communicate recommendations to scientist on process improvements and SOP changes. (PAD II) 
2. Authoring and revising procedural SOPs (PDA II) 
• Author needed procedural SOPs to facilitate training and to ensure process standardization. 
• Revise existing procedural SOPs to reflect current practices. 
3. Recording data 
• Complete all SOPS per GMP. 
• Document any process changes or deviations. 
• Document fermentation data. 
• Gather all documents and print out trends. (if requested). 
• Submit detailed shift reports.(if required). 
• Initial the pass down log for work completed. 
• Communicate maintenance issues. 
4. Pilot plant housekeeping 
• Ensure pilot plant and equipment is kept clean. 
• Perform routine microbiological monitoring (swabs, plating). 
• Assist in checking chemical/supply inventory and notifying when items are needed. 
• Enter received chemicals in Chemical Inventory. 
• Inform supervisor of maintenance issues and submit facilities requests for needed repairs. 
5. Troubleshooting 
• Assist with scientific troubleshooting (organism problems, feeding, etc. using trend data to identify possible solutions). 
• Perform scientific troubleshooting (organism problems, feeding, etc. using trend data to identify possible solutions). (PDA II) 
• Assist YSI repairs/maintenance including calibrations and membrane changes. (PDA II) 
• Troubleshoot mechanical or software issues. (PDA II) 
6. Assist in training new PDAs. 
7. Other duties as assigned by Team Leader 

Minimum Education & Experience for PDA II 
BS/BA in life sciences and 3+ years of fermentation and/or microbial downstream processing experience. Or equivalent level of experience and education.

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