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.

The Analytical Development (AD) group in our Morrisville, NC location is seeking a dynamic Senior Scientist to manage the team-based execution of assay establishment and qualification activities for client programs, as well as ensuring long term success of the methods entering into QC.

The successful candidate will focus on evaluating client methods to ensure that they adhere to FDB best practices, identifying any equipment or procedural gaps, generating qualification protocols, managing qualification execution, and generating qualification summary reports.. The role will oversee individuals executing protocols, review data, ensure a seamless transition to the QC group in a manner that sets them up for “right first time” and prolonged execution success, troubleshoot issues/spearhead investigations, and work closely with the QA group and client SMEs throughout. The candidate will also be expected to follow cGMP documentation practices and initiate deviations, lab investigations, method revisions and other related activities within the quality system. 

The successful candidate requires the following knowledge, skills and abilities:

• Project management expertisefor analytical activities (planning, timeline creation, team management, effective escalation, drive for success and on-time completion of activities)
• Technical expertisein several of the following fields, specifically in the analysis of proteins: plate based assays (SoftMax Pro), mass spectrometry, H/UPLC (Empower), and electrophoresis. As a senior scientist, you must have demonstrated problem solving capabilities for standard biopharmaceutical laboratory techniques.
• Designing, managing and executing protocolsfor the Qualification of recombinant biopharmaceutical protein analytical methods. Experience with Master Control for document management is desired.
• Managing a team of scientistsin a direct or matrix environment with an eye towards team development with high performing scientists.
• Regulated GMP experience, with knowledge of ICH guidelines for methods, positive working relationships with Quality groups and experience with opening, executing and closing protocol events, investigations and change controls within Trackwise. Regulatory audit experience is a plus.
• Strong oral and written communication skills. Experience working in a contract manufacturing or testing organization is preferred (demonstrated ability to engage with clients). The optimal candidate will have a keen eye for detail, excellent writing skills, and desire to engage in a positive manner with clients.
• Continuous improvementinitiatives (initiating and completing).
• Excellent interpersonal skills, the ability to work individually or as part of a team; a person who highly values collaboration.
• Comfortable multi-taskingin a fast-paced environment with defined deliverables and deadlines.

Required education and experience:

The position typically requires at a minimum a PhD and 1+ year experience, MS and 6+ years’ experience or BS and 10+ years’ experience in the biopharmaceutical 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.