Manufacturing Associate (586E)
The primary focus of the Manufacturing Associate role will be cellular therapeutic manufacturing at JuMP during process transfers, routine production, and technology improvements.
The key deliverables for this role are (1) helping to establish the JuMP manufacturing operations and (2) completing production assignments with a high quality and timely output.
- Performing patient process unit operations and support operations described in standard operating procedures and batch records.
- Completing documentation required by process transfer protocols, validation protocols, standard operating procedures, and batch records.
- Performing tasks in a manner consistent with the safety policies, quality systems, and GMP requirements.
- Completing training assignments to ensure the necessary technical skills and knowledge.
- Assisting in setting up manufacturing areas and equipment/fixtures. Perform facility and equipment commissioning activities.
- Writing manufacturing operating procedures that are technically sound, promote effective and efficient operations, and comply with cGMP requirements
- Working with production planning, Sr. Manufacturing Manager, and lead associates to establish daily unit operations schedule that includes people, product, and material flow across multiple shifts.
- 0-2 years of experience in cGMP biologics cell culture manufacturing, experience in cell therapy manufacturing preferred.
- Experience in the following preferred:
- Aseptic processing in ISO 5 biosafety cabinets.
- Universal precautions for handling human derived materials in BSL-2 containment areas.
- Cell expansion using incubators and single use bioreactors.
- Cell washing processes and automated equipment.
- Cell separation techniques and automated equipment.
- Cryopreservation processes and equipment.
- Knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing.
- Bachelors in relevant science or engineering discipline, or equivalent in work experience.
Our headquarters, situated in the bustling South Lake Union district of Seattle, sits among some of the most visible organizations in the world. Seattle offers award-winning restaurants, a vibrant, hip music scene and spectacular views of water and mountains. Within an hour’s drive of Seattle, you can be fishing, skiing, hiking or tasting world-class Washington wines.
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