cGMP Specialist
University of Nebraska-Lincoln
- Lincoln, NE
- $60,000 per year
- Permanent
- Full-time
Department Bio Process Development Facility-7775
Requisition Number S_231131
Posting Open Date 11/21/2023
Application Review Date: (To ensure consideration, please submit all application materials before review date) 04/19/2024
Posting Close Date
Open Until Filled Yes
Description of WorkDevelopment and scale-up of purification processes to the production site for generating cGMP clinical trial material. Assist with production of cGMP material for Phase I/II clinical trials. Verify and assist with run preparations consisting of media/buffer prep, equipment calibration, and cleaning and sterilization. Monitor and troubleshoot engineering and cGMP production runs in the BPDF GMP suite. Create equipment and process validation protocols. Verify performance of equipment and process validation protocols and assist in documentation of these studies. Supervise technicians and/or students. Irregular work hours may be required.Candidates for this position must be a US Citizen, Permanent Resident, Refugee or Asylee in order to work on projects subject to Export Control regulations.The University of Nebraska-Lincoln seeks to attract and retain a high performing and diverse workforce in which employees' differences are respected and valued to better meet the varying needs of the diverse populations we serve. The university fosters a diverse and inclusive work environment that promotes collaboration so that all individuals are able to participate and contribute to their full potential. As an EO/AA employer, the University of Nebraska considers qualified applicants for employment without regard to race, color, ethnicity, national origin, sex, pregnancy, sexual orientation, gender identity, religion, disability, age, genetic information, veteran status, marital status, and/or political affiliation. See .
Minimum Required QualificationsBachelor's degree in a science or engineering related field or equivalent combination of experience and education. Protein purification experience is important. The position requires proficient knowledge of downstream processing operations typical to Pichia/E. coli expressions systems. Skilled in the operation of basic laboratory equipment and computer software. Ability to troubleshoot/problem solve effectively. Must possess excellent verbal and written communication skills and be able to follow verbal and written directions correctly. Ability to multi-task and change work priorities quickly due to the fast-paced work environment. Ability to work well with others in a team-oriented format and be willing to help other areas of the BPDF if required to meet deadlines.
Preferred QualificationsPrefer experience with fermentation and purification as well as knowledge of cGMP/cGLP's for proper record-keeping and project performance.
Pre-Placement Driving Record Review Required No
Physical Required No
Commercial Driver's License (CDL) required. Subject to DOT approved pre-employment & random testing for alcohol and controlled substances.
Criminal History Background Check Required Yes
Posted Salary $60,000/yr. minimum
How to ApplyClick on “Apply for this Job”. You will then either create an application or edit your current application that is on file. You will be required to attach your resume, cover letter and list of references as three (3) separate documents in MS Word or PDF format.
For questions or accommodations related to this position contactCathy Norquest cathy.norquest@unl.edu
Job Category (old) Managerial/Professional
Job Type Full-Time
Alternate Work Schedule (if other than 8-5)
Work Location (City, State) Lincoln, NE
Position funded by grant or other form of temporary funding? Yes
If Temporary, indicate end date
Planned Hire Date:
Appointment End DateSupplemental QuestionsRequired fields are indicated with an asterisk (*).Required DocumentsRequired Documents * Resume
- Cover Letter
- List of References