GMP Biomanufacturing Operator I (Mon-Fri 7:30am - 4:00pm)

Danaher•Fargo, ND

4d•Onsite

About The Position

The GMP Biomanufacturing Operator I is an onsite role in the GMP Manufacturing department in Fargo, North Dakota. As part of the GMP Biomanufacturing Team, the operator executes production events in a GMP manufacturing environment supporting pDNA, mRNA, and protein products. The position reports to the GMP Supervisor. The operator follows safety, quality, and regulatory expectations; maintains manufacturing areas in an audit-ready condition; and follows gowning protocols, standard operating procedures, and good documentation practices. The stated schedule is Monday through Friday, 7:30 a.m. to 4:00 p.m. Schedule flexibility, including weekend work or extended or altered schedules, may occasionally be required depending on production needs.

Requirements

High school diploma or GED.
Ability to read, write, and understand English and apply basic math.
Good communication skills for reporting, documentation, and scheduling.
Ability to use hands; stand and/or sit for extended periods; bend; and lift up to 50 pounds.
Ability to stand, sit, stoop, bend, walk, reach, squat, kneel, push, and pull for long periods; climb a ladder; and flex the upper and lower body.

Nice To Haves

Previous experience working in a manufacturing or GMP biomanufacturing setting.
Previous experience following standard operating procedures.
Schedule flexibility for weekend work or extended or altered schedules, as production needs require.

Responsibilities

Execute manufacturing processes including transformations, cell banking, fermentation, lysis, chromatography, diafiltration, and final fill for pDNA, mRNA, and protein products.
Maintain a safety-first and audit-ready mindset and manage the environment within manufacturing areas.
Follow gowning protocols, standard operating procedures, good documentation practices, and regulatory expectations to maintain a quality-first approach.