Scientist II, Bioassay Development
Research Triangle Park, North Carolina
The Bioassay Development group is seeking a Scientist II with experience in cell-based assays, ELISAs and Plate-based testing. 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 support the management/report of deliverables to internal &/or external customers, 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 cell-based methods, ELISAs and qPCR 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
- Direct experience using ELISAs for protein characterization and release testing
- Direct experience in qPCR methods for residual DNA quantitation and/or other manual and/or automated plate based methods
- Direct experience using 96-well plate-based assays for protein characterization and release testing
- Direct experience in interaction with internal and/or external customers to ensure deliverables fall within the applicable scope and budget
- 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 SPR/Biacore and /or other enzyme/protein binding methods
- Experience in Lean Six-Sigma principles and its implementation across project management and lab operations
- Experience in TOC Development and/or other analytical methods to support Cleaning Validation
The position typically requires an MS and 3+ years’ experience, BS and 7+ years’ experience and is an entry level position for a PhD degree with no prior experience.
The individual should have demonstrated proficiency in the following areas:
- Advanced knowledge of chemistry and/or biochemistry and associated techniques
- Independent planning, execution and interpretation of routing and non-routine laboratory experiments
- General knowledge of Excel, Word and PowerPoint
- Have acquired broad scientific knowledge within their own scientific discipline and applies best practices to client projects
- An understanding of instruments, computer technology, and data analysis required to successfully complete project work
- Ability to monitor on-going experiments and suggest alternates or solutions to unusual occurrences
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 identity or any other protected class.