Primary responsibility: Operate general manufacturing equipment under close supervision in accordance with quality standards/SOPs and safety guidelines in the production of Flublok Drug Substance (downstream processing: clarification/purification) and buffer preparation in a cGMP commercial facility.
Responsibilities:
- Operate, maintain, clean, and sanitize downstream processing equipment (stainless-steel vessels/transfer lines; tube welders/sealers; peristaltic pumps; WFI point-of-use taps).
- Execute centrifugation, depth filtration, chromatography (column purification/packing), tangential flow filtration; perform CIP/SIP of process equipment.
- Clean and prepare workspaces and biosafety cabinets; use aseptic technique; perform preventive maintenance and changeovers (biosafety cabinets, magnetic mixers, in-process testing equipment).
- Support troubleshooting; perform database entry and cross-training/coverage in flex areas as needed.
- Ensure GDP and cGMP documentation and records; complete required cGMP training.
- Follow SOPs for flow of materials/personnel/equipment in/out of cGMP facility; participate in facility cleaning.
- Work flexible schedules (weekends/holidays as required) and coordinate deviations/CAPAs with Compliance.
Qualifications/Skills:
- High School Diploma + at least 1 year work experience OR Bachelorβs degree (no prior experience).
- Preferred: cGMP manufacturing environment training.
- General knowledge of cGMP, GDP, and SOPs; fluent English (written/spoken); good communication.
- Preferred/desired: basic BEVS manufacturing process understanding.
Benefits (if applicable): high-quality healthcare, prevention/wellness programs, and at least 14 weeks gender-neutral parental leave.