Join us
We are growing our locations and are investing more than $2 billion into establishing a new large-scale manufacturing site for biopharmaceuticals in the United States to accelerate the growth of our Bio CDMO (Contract and Development Manufacturing Organization) business. This will be the largest end-to-end cell culture CDMO provider in North America.
The new site will offer end-to-end solutions to our customers looking to manufacture biopharmaceuticals in the US. In addition to drug substance manufacture, it will also provide automated fill-finish and assembly, packaging, and labeling services. The new state-of-the-art facility is located in Holly Springs, North Carolina, United States.
About This Role
The QC Raw Materials (RM) Scientist 1 will be responsible for participating in the Technology Transfer of raw material methods into FDBN Quality Control Laboratory, with limited supervision. This includes onboarding of new and generic raw materials as part of new customers/programs. Providing assessments, QC raw materials requirements and executing action items for change controls for the onboarding of these materials based on vendor documentation. Identifying materials together with customers in a cross functional team. Planning and tracking QC readiness for clinical and commercial manufacturing. Provide technical knowledge to assess testing approach, verification and validation needs both internally and at external contract labs. Performs QC RM review of Specification Justification Reports (SJR). Provide technical support for troubleshooting of investigations related to testing of new materials. Authoring specifications according to the SJR's and requesting creation of LIMS builds for the new material. All documentation is in accordance with GMP and ensure all reported results are accurate. Following Tech-Transfer Activities, the position will be responsible for performing release testing using the established analytical methods.
Minimum Requirements
Preferred Requirements
PHYSICAL DEMANDS
ENVIRONMENTAL CONDITIONS
FDBN 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 email FDBN_PNC@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.
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