Scientist I, Bioassay Development
Research Triangle Park, North Carolina
The Bioassay Development group is seeking a Scientist I analyst with experience in cell-based, qPCR, ELISA or Enzyme/potency/binding plate-based assays. The successful candidate will primarily be responsible for the development and qualification of assays for the characterization and identity, purity, and strength assessment of recombinant protein drugs. The position will also provide sample testing support to process development, independent generation of analysis reports and other documentation. The successful candidate will also be responsible for the development and qualification of qPCR and ELISA assays for the characterization and testing of recombinant protein drugs.
The successful candidate requires the following knowledge, skills and abilities:
- Direct experience using cell based assays for protein characterization and release testing
- Independent use and application of instrumentation, computer systems and software for data acquisition and analysis
- Basic math and software skills (MS Excel, Word, PowerPoint)
- Good interpersonal skills, the ability to work individually or as part of a team, and strong problem solving capabilities. Have strong oral and written communication skills.
- Experience working in a regulated GMP environment is highly desirable
- In addition, the successful candidate must be comfortable multi-tasking in a fast-paced environment with defined deliverables and deadlines
Optional additional experience which would be beneficial to the role:
- Experience in qPCR methods for residual DNA quantitation and/or other plate based methods
- Experience in SPR/Biacore methods for protein characterization and GMP release testing
- Experience in TOC Development and/or other analytical methods to support Cleaning Validation
MS and 1+ years lab experience or equivalent; BS and 5+ years lab experience or equivalent in the Biotech/Biopharma industry.
FDBU works with technical data, technology and materials that are subject to U.S. export laws and regulations. This position will require access to technical data, technology and source code that is controlled under U.S. export laws and regulations, including but not limited to the International Traffic in Arms Regulations at 22 C.F.R. Parts 120 – 130 and Export Administration Regulations in 15 C.F.R. Part 730 – 774, as may be amended. To conform to these laws and regulations, applicants must be U.S. citizens, lawful permanent residents of the U.S., protected individuals as defined by 8 USC 1324(b)(a)(3) (i.e., asylees and refugees) or otherwise eligible for an export authorization from the U.S. Department of State or U.S. Department of Commerce. Offers of employment will be contingent on the Company’s ability to secure an export authorization.
FDBU is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation, gender identify or any other protected class.