Manufacturing Associate I or 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 (Upstream) to join the manufacturing department.
The Manufacturing Associate performs and documents daily manufacturing operations in a cGMP environment that involves operations 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, cell culture in flasks and bioreactors.
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 cell culture according to Batch Records, including product operations, 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.
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 bioreactors is a must. Preferably at least 1 year with 10 L Glass bioreactors and 1000 L single use bioreactors.
An detail understanding of cGMP and CFR-210 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.