Scientist I, Bioassay Development

The Bioassay Development at FUJIFILM Diosynth Biotechnologies U.S.A., Inc. in RTP, North Carolina, group is seeking a Scientist I analyst with experience in cell-based, TOC development, 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.

External US

The work we do at FDB has never been more important—and we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people's lives. Join FDB and help create the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe. We are proud to cultivate a culture that will fuel your passion, energy and drive - what FDB call Genki.

The Bioassay Development at FUJIFILM Diosynth Biotechnologies U.S.A., Inc. in RTP, North Carolina, group is seeking a Scientist I analyst with experience in cell-based, TOC development, 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
• Direct experience in TOC Development and/or other analytical methods to support Cleaning Validation
• 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.
• Direct 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

Preferred Experience
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. If an accommodation to the application process is needed, please e-mail FDBUHR@fujifilm.com.

To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.