Backed by 500 Global.
About the role
The Senior Analyst 1, QC Analytical Development (AD) Chemistry works with limited direction to support the execution of analytical method transfers and validations for drug substance (DS) and drug product (DP) manufacturing into the Quality Control laboratories of FUJIFILM Biotechnologies Holly Springs. Found on 1752vc Careers, the job board for startup and VC roles.
What they're looking for
- Knowledge of cGMPs, ICH, USP, EP, JP and FDA requirements as it relates to physical and chemical analytical methods
- Working knowledge and experience in Microsoft Office products (Outlook, Word, Excel, and Power Point)
- Ability to work with minimal supervision
- Ability to effectively communicate and function in a fast-paced, highly technical environment is essential to success
- Demonstrated ability to work cross-functionally and to develop and maintain strong business partner relationships
- Excellent verbal and written communication skills and attention to detail
More about this role
The Senior Analyst 1, QC Analytical Development (AD) Chemistry works with limited direction to support the execution of analytical method transfers and validations for drug substance (DS) and drug product (DP) manufacturing into the Quality Control laboratories of FUJIFILM Biotechnologies Holly Springs. The analytical chemistry methods used in biological product manufacturing include chromatography, spectroscopy, electrophoresis, wet chemistry, glycan analysis, sub-visible particle analysis, peptide mapping, and physical appearance, etc. The Senior Analyst 1, QC AD Chemistry adheres to GMP compliant laboratory operations in accordance with regulatory guidelines. This role executes analytical method transfers from clients and authors and reviews procedures, SOPs, and technical reports.
FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. By end of 2025, we’ll open North America’s largest end-to-end CDMO biopharmaceutical manufacturing facility, offering drug substance production, fill-finish, and packaging under one roof.
We’re looking for passionate, mission-driven people to help us realize this exciting vision and deliver the next...
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