Senior QC Chemistry Analyst – Onsite GMP Biotech

FUJIFILM Electronic Materials (Europe) N.V.; Holly Springs (NC); On-site; USD 70,000 - 95,000; Full time

Job summary

FUJIFILM Biotechnologies in Holly Springs, NC is seeking a Senior Analyst 1, QC Chemistry to execute physical and chemical analytical methods used in biological product manufacturing, including chromatography, spectroscopy, electrophoresis, glycan analysis, and peptide mapping, while upholding GMP-compliant laboratory operations.

You will generate analytical results, manage deviations and CAPAs, support method transfers and validations, train lab staff, and collaborate with Manufacturing,

Qualifications

• Bachelor’s Degree in Chemistry, Biochemistry, Biological Sciences, Engineering, or related science field with 3+ years of experience.
• 3+ years laboratory experience.
• 1-3 years GMP laboratory experience.
• Experience with physical and chemical analytical testing methods used in biological product manufacturing including chromatography (GC, HPLC, UPLC, SEC), spectroscopy (MS, GC/MS, LC-MS/MS, UV, UV-Vis, FTIR), electrophoresis (GE, non-reducing and reducing CESDS, imaged capillary isoelectric focusing (icIEF)), wet chemistry, glycan analysis, sub-visible particle analysis, peptide mapping, and physical appearance, etc.

Responsibilities

• Executes physical and chemical analytical testing methods used in biological product manufacturing, including chromatography (GC, HPLC, UPLC, SEC), spectroscopy (MS, GC/MS, LC-MS/MS, UV, UV-Vis, FTIR), electrophoresis (GE, non-reducing and reducing CESDS, imaged capillary isoelectric focusing (icIEF)), wet chemistry, glycan analysis, sub-visible particle analysis, peptide mapping, and physical appearance, etc.
• Ensures analytical testing of in-process, drug substance (DS), drug product (DP), and stability samples is performed according to appropriate GMP regulations.
• Ensures analytical testing data is captured in LIMS software and data integrity is maintained.
• Reports assay performance and assists with implementing improvements that ensure quality and efficiency within QC Chemistry.
• Identifies and follows up on excursions and deviations and initiates corrective and preventative actions (CAPAs).
• Coordinates and supports QC Chemistry lab activities as needed.
• Provides training for QC Chemistry lab associates.
• Authors and reviews SOPs and technical reports.
• Works cross-functionally with other QC departments, Manufacturing, Process Science, and Quality Assurance stakeholders to achieve customer and FUJIFILM Biotechnologies objectives.
• Performs other duties, as assigned.

Job description

FUJIFILM Biotechnologies in Holly Springs, NC is seeking a Senior Analyst 1, QC Chemistry to execute physical and chemical analytical methods used in biological product manufacturing, including chromatography, spectroscopy, electrophoresis, glycan analysis, and peptide mapping, while upholding GMP-compliant laboratory operations.

You will generate analytical results, manage deviations and CAPAs, support method transfers and validations, train lab staff, and collaborate with Manufacturing,