GMP Biomanufacturing Operator I

Danaher•Fargo, ND

2d•Onsite

About The Position

The GMP Biomanufacturing Operator I works in Aldevron’s GMP Manufacturing department in Fargo, North Dakota, onsite, as part of the GMP Biomanufacturing Team. The role executes production events in a GMP manufacturing environment supporting pDNA, mRNA, and protein products. It requires consistent use of aseptic techniques and a safety- and quality-first approach, including adherence to gowning protocols, standard operating procedures, good documentation practices, and regulatory expectations. The operator collaborates with the team to improve and standardize manufacturing processes using Danaher Business System (DBS) tools and techniques, continuous improvement, customer focus, and collaboration.

Requirements

High school diploma or GED.
Ability to read, write, and understand English.
Good communication skills for reporting, documentation, and scheduling.
Ability to apply basic math, including calculations, arithmetic, ratios, proportions, and conversions.
Ability to use hands, stand and/or sit for extended periods, bend, and lift up to 50 pounds.
Ability to work weekends or extended/altered schedules when production needs require.

Nice To Haves

Previous experience in a manufacturing or GMP biomanufacturing setting.
Experience following standard operating procedures.

Responsibilities

Execute manufacturing processes including transformations, cell banking, fermentation, lysis, chromatography, diafiltration, and final fill for pDNA, mRNA, and protein products.
Consistently practice aseptic techniques to minimize contamination in manufacturing areas.
Follow gowning protocols, standard operating procedures, good documentation practices, and regulatory expectations while maintaining a safety- and quality-first mindset.
Work with the team to improve and standardize manufacturing processes using DBS tools and techniques, continuous improvement, customer focus, and collaboration.
Report and document information and support scheduling as needed.
Self-report mistakes or concerns to the manager.