Senior QC Chemistry Analyst: GMP Lab Execution

FUJIFILM Biotechnologies; Holly Springs (NC); On-site; USD 70,000 - 100,000; Full time

Job summary

FUJIFILM Biotechnologies in North Carolina seeks a Senior Analyst 1, QC Chemistry to execute analytical methods for biological product manufacturing, including chromatography, spectroscopy, and electrophoresis, under GMP conditions.

You will ensure data integrity in LIMS, report assay performance, and assist CAPAs while training lab associates and contributing to method transfers and validations with cross-functional teams.

Qualifications

• Bachelor’s degree in chemistry, biochemistry, biological sciences, engineering, or related field with 3+ years of experience.
• 3+ years of laboratory experience in GMP environment.
• Experience with analytical testing methods including chromatography, spectroscopy, electrophoresis, glycan analysis, etc.
• Experience with data capture in LIMS and maintaining data integrity.

Responsibilities

• Execute analytical testing methods used in biological product manufacturing (chromatography, spectroscopy, electrophoresis, etc.).
• Ensure testing of in-process, DS, DP, and stability samples complies with GMP.
• Capture analytical data in LIMS and ensure data integrity.
• Report assay performance and support improvements for quality and efficiency.
• Identify excursions and deviations and initiate CAPAs.
• Coordinate and support QC Chemistry lab activities.
• Provide training for QC Chemistry lab associates.
• Authors and reviews SOPs and technical reports.
• Collaborate with QC, Manufacturing, Process Science, QA to meet objectives.

Skills

Laboratory experience

GMP knowledge

Data integrity

Education

Bachelor’s degree in Chemistry/Biochem/Biology/Engineering

Master’s degree preferred

Tools

LIMS software

GMP laboratory equipment

Job description

FUJIFILM Biotechnologies in North Carolina seeks a Senior Analyst 1, QC Chemistry to execute analytical methods for biological product manufacturing, including chromatography, spectroscopy, and electrophoresis, under GMP conditions.

You will ensure data integrity in LIMS, report assay performance, and assist CAPAs while training lab associates and contributing to method transfers and validations with cross-functional teams.