Role Summary
The candidate will work in a manufacturing laboratory setting in Lincoln, NE, supporting a large-scale biological production campaign. The candidate will use mammalian cell culture techniques as well as purification techniques (centrifugation, chromatography, ultrafiltration, and nanofiltration). The candidate will follow and complete process documentation in support of good manufacturing practices (GMP). The candidate will also understand and follow safety policies as they relate to biological components, chemical components, and equipment to protect personnel and maintain product quality. Hours: Swing Shift, 10:30am - 7:00pm; 8-hour days (M-F) and rotating weekends. Holidays may be required.
Responsibilities
- Perform processes and operate equipment required for large-scale monoclonal antibody (mAb) production campaigns.
- Support large-scale biological production campaigns for GMP by performing:
- Aseptic inoculation and growth of mammalian cultures of various sizes
- Operation of bioreactors/fermenters, Tangential flow filtration (TFF), centrifugation, chromatography, and ultra-purification processes
- Cleaning and steam-in-place activities for equipment
- Maintain equipment and problem solve as needed.
- Understand, follow, and accurately complete process documentation to maintain a high level of product quality.
- Understand and follow safety policies.
- Work collaboratively with members of other departments.
Qualifications
- Required: High school degree or equivalent.
- Preferred: BS in Biological sciences or a related field.
- Preferred: Previous experience in large-scale production or laboratory scale.
- Preferred: Excellent communication skills and attention to detail.
- Preferred: Ability to prioritize work, think critically, and take initiative.
- Preferred: Ability to work well in a team environment as well as work independently with minimal supervision when needed.
- Preferred: Experience in biological production, aseptic manufacturing, or in a regulated environment.
Skills
- Functional: Ability to read and follow written directions.
- Functional: Ability to complete basic calculations.
- Functional: Ability to think critically.
- Technical: Basic mechanical skills.
- Technical: Ability to troubleshoot.
- Technical: Knowledge of the metric system.
- Desirable: Mammalian cell culture practices and techniques.
- Desirable: Fundamental understanding of bioreactors/fermenters or downstream purification techniques.
- Desirable: Basic understanding of biological and chemical principles.
- Desirable: Experience with computers.
- Desirable: Experience within a regulated environment.
Education
- High school diploma or equivalent is required.
Additional Requirements
- Exposure to chemicals, fumes, odors, noise, live steam, temperature fluctuations, biohazards; continuous standing and lifting to a maximum of 50 lbs.