Analyst 1, QC Chemistry

21h21 hours ago

Fujifilm

Holly Springs, US · Full-time · $65,000 – $85,000

About this role

The Analyst 1, QC Chemistry works with direction to execute QC Analytical Chemistry methods used in biological product manufacturing, including chromatography, spectroscopy, electrophoresis, wet chemistry, glycan analysis, sub-visible particle analysis, peptide mapping, and physical appearance. This role adheres to GMP-compliant laboratory operations in accordance with regulatory guidelines and standard operating procedures. It generates analytical results and identifies laboratory exceptions, invalid assays, and deviations.

Primarily responsible for executing routine analytical methods in support of manufacturing, the role ensures physical and chemical analytical testing of in-process, drug substance, drug product, and stability samples follows standard operating procedures. Analytical testing data is captured in LIMS software while maintaining data integrity. The Analyst reports assay performance and assists with improvements for quality and efficiency within QC Chemistry.

Identifies excursions and deviations, coordinates QC Chemistry lab activities, and works cross-functionally with other QC departments, Manufacturing, Process Science, and Quality Assurance stakeholders. This supports achievement of customer and FUJIFILM Biotechnologies objectives. The role performs other duties as assigned.

FUJIFILM Biotechnologies offers a flexible work environment and cultivates a Genki culture that fuels passion, energy, and drive. The state-of-the-art biomanufacturing facility combines innovation with a dynamic location. Join to collaborate with industry leaders on vaccines, cell and gene therapies, transforming the future of medicine.

Requirements

Bachelor’s Degree in Chemistry, Biochemistry, Biological Sciences, or related science field with 1-3 years relevant experience
1+ years laboratory experience
1-3 years GMP laboratory experience
Experience with physical and chemical analytical testing methods used in biological product manufacturing including spectroscopy (UV, UV-Vis, FTIR), wet chemistry, and physical appearance
Experience with chromatography (GC, HPLC, UPLC, SEC)
Experience with electrophoresis (non-reducing and reducing CE-SDS, imaged capillary isoelectric focusing)

Responsibilities

Execute physical and chemical analytical testing methods used in biological product manufacturing, including chromatography (GC, HPLC, UPLC, SEC), spectroscopy (UV, UV-Vis), electrophoresis (non-reducing and reducing CE-SDS, imaged capillary isoelectric focusing), wet chemistry, glycan analysis, sub-visible particle analysis, peptide mapping, and physical appearance
Ensure analytical testing of in-process, drug substance (DS), drug product (DP), and stability samples is performed according to standard operating procedures
Ensure analytical testing data is captured in LIMS software and data integrity is maintained
Report assay performance and assist with implementing improvements that ensure quality and efficiency within QC Chemistry
Identify excursions and deviations
Coordinate and support QC Chemistry lab activities as needed
Work cross-functionally with other QC departments, Manufacturing, Process Science, and Quality Assurance stakeholders to achieve objectives