Manufacturing Associate, I-II(Downstream)
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 Downstream 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. The 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.
Primary responsibility will be to execute GMP operations in a class 100,000 (ISO 8) and class 10,000 (ISO 7) cleanrooms.
Perform routine manufacturing activities of purification according to Batch Records, including product operations, line clearance, equipment processing, weigh and dispense operation, wash/autoclaving parts, buffer/media preparations and sample coordination.
- Operate and maintain manufacturing equipment, which includes but is not limited to purification columns, TFF skid.
- 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.
- Address production issues and participate in technical investigations in collaboration with quality, clients and quality teams.
- 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
Education and Experience:
- Bachelor degree in Science or Engineering. 1-2 years' experience in the biotech/pharmaceutical industry. Associates degree acceptable with related experience.
- Experience with cell culture purification is a must. Preferably more than 2 years Affinity Chromatography, Size Exclusion Chromatography, Ion Exchange Chromatography, Hydrophobic Interaction, and Tangential Flow Filtration
- Pack, sanitize and test columns
- Product Filtration (sterile filtration, ultrafiltration, and viral filtration)
- Fill and Finish
- A detailed understanding of cGMP, CFR-210, and CFR-211.
- Knowledge, skills and abilities:
- Effective communication, teamwork skills and attention to details
- Proficient with Microsoft Word and Excel
- Ability to move of heavy equipment and the ability to lift ~50 pounds
- Ability to work with pressurized systems, steam, and corrosive chemicals with necessary safety precautions.