The Fujifilm Diosynth Biotechnologies, USA Analytical Development group is seeking a skilled scientist to fill an exciting technical leadership role as Senior Scientist located at the Bioprocess Innovation Center in Morrisville, North Carolina.
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.
The successful candidate will lead the matrix team execution of client-based projects within the Analytical Development group. The individual will have demonstrated expertise in the development and application of analytical methods for the release and characterization of recombinant biopharmaceutical products. The candidate will have demonstrated success in technical proficiency, scientific creativity, collaboration with others and independent thought. This position will contribute to the success of projects in various stages of cross-functional development and tech transfer by designing and planning all analytical aspects of the project, monitoring timeline adherence, reviewing scientific data, writing protocols and reports, representing the analytical development group in client interactions and managing project deliverables internally and externally.
Experience working in or interfacing with a regulated GMP environment is desirable
Experience managing scientists in a direct or matrix environment
Experience working in a contract manufacturing or testing organization is preferred (demonstrated ability to work with clients)
This position typically requires a Ph.D. and 2+ year experience in the biotechnology/biopharmaceutical industry or;
MS and 6+ years' experience in the biotechnology/biopharmaceutical industry or
BS and 10+ years' experience in the biotechnology/biopharmaceutical industry.
Demonstrated ability designing, managing, and executing analytical studies to support the development and cGMP manufacturing of recombinant biopharmaceutical proteins
Experience with the development and application of state of the art methods for release and characterization of recombinant biopharmaceutical protein-based products. The successful candidate must have extensive experience with at least two of the following: liquid chromatography (HPLC/UPLC), capillary electrophoresis, isoelectric focusing, and mass spectrometry
Ability to comfortably and effectively multi-task in a dynamic and fast-paced environment with defined milestones and deadlines
Excellent interpersonal skills including the ability to work as an individual contributor, with internal customers as part of a cross-functional team, and with external clients
Ability to apply problem-solving skills independently to analytical issues, as well as within the context of cross-functional teams for larger project issues
Written communication skills including experience writing protocols, summary reports, and test methods
Oral communication skills including experience presenting technical project status and data-driven updates to internal and/or external customers.