Execute daily production operations within a cleanroom environment. The activities will include but are not limited to cell expansion in an aseptic environment, bioreactor operations, depth filtration, purification through TFF (Tangential Flow Titration), chromatography and various filtration techniques, and product filling via manual, semi-automated, or automated filling.Ensure cleanrooms are cleaned, organized, maintained, and audit ready at all times. Maintain department inventory and ensure all materials are kitted for upcoming cleanroom operations.Maintain individual training plan and ensure your training profile remains up to date with training readiness at all times.Attend meetings, send/receive emails, participate in continuous improvement projects. When necessary, demonstrate strong technical writing abilities (deviation initiations, SOP creation, etc.).
1-4 years
Any combination to include but not limited to Monday through Friday, alternating days, 8, 10, and 12 hour shifts. Ability to work nights, weekends, and holidays.Must know the following job safety procedures, attend required health and safety training, proactively promote safety at work, and promptly report actual and potential accidents and injuries. Must comply with safety policies of the company.Adherence to cGMPs (and/or ISO standards) is required at all times during the manufacture of APIs, drug products, media, buffers, and research products. All personnel own the quality of what they deliver and are responsible for notifying responsible management in a timely manner of regulatory inspections, serious GMP deficiencies, process deviations, product defects, and related actions.
AS/BS in Biotechnology, Biology, Chemistry, or equivalent.Preferred area of study: Science related discipline. High school diploma or equivalent may be considered with relevant experience.0-2 years of experience in manufacturing (minimum 2 years experience without AS/BS); GMP setting preferred, previous upstream and/or downstream experience preferred.
High School
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