Biomanufacturing Operator III in Fargo, North Dakota For Sale
Position Summary:
The Biomanufacturing Operator III will work daily within Aldevron's labs performing tasks associated with Aldevron's GMP-Source (GMP-S) services. The Biomanufacturing Operator III is expected to become familiar with all of Aldevron's products and to be able to perform most tasks associated with the purification of plasmid DNA.
Essential Duties and Responsibilities:
The Biomanufacturing Operator III is primarily responsible for the following tasks:
Segregation, line clearance and cleaning of GMP-Source production areas.
Planning and preparation for production events including preparing processing plan memos, completing inventory requisitions, and coordinating with buffer preparation operators.
Execution of GMP-Source projects per Aldevron's SOPs and within all regulatory guidelines with either upstream or downstream tasks and all special considerations associated.
Upstream tasks including: Transformation, subculture, cell banking, shake flask growth and harvest, Wave growth and harvest, fermentation, final formulation, filtration and dispensing.
Downstream tasks including: Project Set up, Lysis, Anion Exchange Chromatography, and Hydrophobic Interaction Chromatography (void and enrichment), Thiophilic Absorption Chromatography, Diafiltration, and small scale processing as well as linearization.
Completion of all documentation associated with GMP-Source projects.
Equipment calibration and preventative maintenance, and assisting Metrology as needed.
Packaging of final material prior to shipment.
Coordination and sample submission with Quality Control.
Participate and support of Aldevron's internal audit program by providing requested information and responding to findings presented in the audit report.
Help maintain working inventory levels. Maintain freezer inventory system.
Complete project component lists. Assisting in writing Manufacturing Summary Reports after project completion.
Maintain of training records.
Communicate the status of operations, process issues, and safety and maintenance issues to appropriate area management.
Completing Quality Metrics Tracking.
Qualifications:
Experience:
2 years lab experience required, GMP/GLP experience preferred
Education:
Bachelor's Degree in Life Sciences (Biology, Chemistry, Biotech) preferred
Abilities:
Perform basic math (arithmetic, ratios, proportions and conversions)
Have good depth perception and steady hands for pipetting
Good organizational skills
Communicate effectively
Working Conditions:
This position works in a segregated lab setting and may come in contact with various solutions and chemicals, and will be responsible for biological processes such as bacterial growth.
Physical Requirements:
This position is required to lift 40 pounds or more on a regular basis.
This position stands for long periods of time.
This position routinely moves large pieces of equipment.
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