San Diego | California | United States | 92121
Process Development Associate II (PDA II) - San Diego Pilot Plant
Under minimal supervision design and carry out fermentation /recovery experiments, recording data, maintenance/housekeeping and troubleshooting.
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
• 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.
• 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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