Manufacturing Associate I/II
Vista Biologicals provides highly specialized cell culture, process development, and cGMP manufacturing services for the biotechnology and biopharmaceutical industries, utilizing cell culture to support pre-clinical, Phase I - II production.
Vista Biologicals Corporation (VBC) is currently seeking a talented and innovative Manufacturing Associate to join the manufacturing department.
The Manufacturing Associate performs and documents daily manufacturing operations in a cGMP environment that involves operation of various process equipment, execution of protocols, creating/revising cGMP documents and other assignments. The candidate should be highly detail oriented with excellent documentation skills. Candidate will be trained in most or all unit operations in their area, often leading the execution of procedures, and performs with minimal supervision. The ideal candidate will have experience with aseptic technique, protein and antibody purification using various columns and filtrations.
Perform routine manufacturing activities of cell culture according to Batch Records in the 10 to 1000L bioreactor and/or protein purification using multiple TFF and chromatography columns, line clearance, equipment processing, weigh and dispense operation, parts wash and autoclaving, buffer and media preparation and sample coordination.
Operate and maintain manufacturing equipment, which includes but is not limited to bioreactors and controllers.
Demonstrate good aseptic technique.
Author and revise manufacturing batch records and SOPs as needed to accurately reflect process steps as transferred from R&D/Client. Able to write DR's, OOL's, OOS's etc. Effective communication, teamwork skills and attention to details.
Address production issues and participate in technical investigations in collaboration with quality, clients and quality teams. A detailed understanding of cGMP and CFR210 and 211.
Participate in cross functional activities to support process improvements, late-stage process characterization and process validation.
Must be able to work weekends, and flexible hours if required. Must be able to lift 50 lbs. Proficient with Microsoft Word and Excel.
Job Requirements for upstream and downstream position.
Upstream Associate Experiences:
- Cell culture
- 10L glass bioreactors, 1000L S.U.B. (single use bioreactors)
Downstream Associate Experiences:
- Cell culture purification.
- Affinity, size exclusion, and ion exchange chromatography. Hydrophobic interaction and tangential flow filtration. Pack, sanitize and test columns.
- Product filtration.