We are ‘Advancing tomorrow’s medicines’ and making a real difference to the world in which we live. At Fujifilm Diosynth Biotechnologies, we partner with our clients to deliver recombinant proteins, viral vaccines and gene therapies to patients. As a Contract Development & Manufacturing Organization (CDMO), our focus is to combine technical leadership in cell culture, microbial fermentation and viral vectors with world class GMP manufacturing facilities to advance tomorrow’s medicines. We seek candidates with proven ability to work independently and collaboratively to achieve optimized strategies, and execution programs with the ultimate goal of delivering products that transform the lives of patients.
Develop and qualify assays for the characterization and identity, purity, and strength assessment of recombinant protein drugs. Provide sample testing support, independent generation of analysis reports, and other documentation. Plan, conduct, evaluate, and interpret lab experiments. Execute complex analytics (ie, microbiology testing, N-glycans, peptide map, robotics, Biacore, Octet). Assist with method troubleshooting and investigations. Maintain lab equipment, supplies and records. Identify opportunities to improve quality of work. Evaluate completeness and accuracy of data collected by other scientists to ensure integrity of data. Train junior scientists. Participate on project teams to provide scientific expertise. Lead OpEx initiatives. Create Standard Work Elements. Write reference material qualification documentation. Develop new analytical methods using a statistical approach. Support technology transfer into Quality Control. Participate in regulatory audit support.
Requirementsts: Master’s degree or equivalent in Pharmaceutical Sciences, Biotechnology, or related, and 1 year of work experience in a protein analytical position or related, including 1 year of experience with: Applying instrumentation, computer systems and software for data acquisition and analysis, including Empower, SoftMax Pro, or Empower Method Validation Manager; Performing statistical analysis using software, including SAS JMP, Fusion QbD, or Excel; Working in a regulated GMP environment; Analyzing proteins, troubleshooting protein-based analytics, and method qualification and/or validation in 3 of the following fields: UPLC/HPLC (using Empower 3), peptide map, N-glycan analysis, capillary electrophoresis (using Maurice or PA800 systems), gel electrophoresis, western blot, or spectrophotometry; Transferring methods into a QC environment.
Mail resume to FUJIFILM Diosynth Biotechnologies U.S.A. Inc., ATTN: Human Resources, 101 J. Morris Commons Lane, Morrisville, NC 27560.
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.