Downstream Production Technician
Research Triangle Park, North Carolina
The work we do at FUJIFILM Diosynth Biotechnologies has never been more important—and we are looking for talented candidates to join us. We’re 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. Here, you’ll work alongside and learn from some of the most dedicated scientists, engineers, and manufacturers in the industry. We’re proud to cultivate a culture that will fuel your passion, energy, and drive—what FDB calls Genki. Join us and discover a community that thrives on diversity and never scares away from a complex challenge. At FDB, you determine what’s possible.
Fujifilm Diosynth Biotechnologies, U.S.A., Inc. is seeking Downstream Production Technicians (all levels) to work in our Downstream Manufacturing group. The successful candidate will execute Development and Production processes as well as the accompanying documentation. This position could either be a day shift position (7:00 am – 7:00 pm) or a night shift position (7:00 pm – 7:00 am). The candidate hired will be working on day shift for the first six months for training, and then transition to the night shift.
Main areas of responsibilities include:
- Executing development and production processes as well as process documentation
- Understanding processing principles and scientific theory behind operations steps
- Demonstrating proficiency at the advanced skill level
- Troubleshooting of equipment/processes
- Authorizing and routing SOPs for approval
- Assisting in the execution of validation protocols
- Initiating deviations as needed
- Independently executing cGMP biotechnology production processes, training and directing lesser skilled employees to execute production process steps
- Assisting with lean continuous improvement projects
- Leading others in application of cGMPs for manufacturing documentation, facilities, and equipment in a biotechnology environment
- Demonstrating a commitment and leading others to maintain high standards of quality, cleanliness, and organization within the manufacturing environment
Required Education, Experience and Skills – Minimum Requirements:
- HS diploma and 1+ years cGMP biotechnology production experience or BS/BA required
- Ultrafiltration, Chromatography and or Centrifugation experience required
- Ability to work any shift
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.