Shift Timing: Flexible (Monday to Friday)
Shift time could vary depending on business need. The team rotates shifts, from Day to Swing to Grave, on a 1–2-month bases to monitor upstream/downstream process.
Description:
Responsibilities (including, but are not limited to):
- Execute manufacturing processes on the floor under supervision, while rigorously following batch records, standard operating procedures (SOPs), and Current Good Manufacturing Practice (cGMP) regulations to ensure manufacturing operations are safe and compliant.
- Ensure right-the-first-time performance of all process steps specific to the phase or stage of operation, as well as help drive the safety-first culture at Client Oceanside.
- Work as part of a team to execute Good Manufacturing Practice (GMP) runs in close collaboration with, Manufacturing Science and Technology (MSAT), Facilities and Engineering (F&E) and Quality departments.
- Under supervision, perform weighing of raw materials, as well as electronic inventory transactions utilizing Manufacturing Execution Systems (MES) and Enterprise Business system (EBS).
- Under supervision, perform cell culture and filling unit operations for the manufacturing of viral vector products in a cGMP environment using proper aseptic technique, proper laboratory etiquette, Good Documentation Practices (GDP), and sound scientific methods.
- Prepare and use single use systems to support solution formulation and filter integrity testing.
- Maintain mammalian cell culture in flasks, CellSTACK chambers and single use bioreactor systems.
- Assist with transfection of cells and harvest of viral vectors.
- Assist with manual and/or automated fill of harvested viral vector material.
- Escalate processing and equipment issues as needed.
- Assist with revisions of SOPs, Manufacturing Production Record (MPRs), and other controlled documents.
- Assist in the review of in-process cGMP documentation for completeness, accuracy, and compliance.
- Ability to work effectively in an inclusive, cross-functional, team-based environment.
- Able to work off shift hours and weekend.
- Additional duties as assigned.
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