Senior QC Chemistry Analyst — GMP Lab Excellence

Merck & Co.; 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 analytical methods across chromatography, spectroscopy, electrophoresis and other QC testing, ensuring GMP compliant operations. You will generate results, manage CAPAs, support analytical method transfers and validations, and train QC Chemistry staff.

Collaboration with Manufacturing, Process Science and QA is essential, with cross-functional objectives.

Qualifications

• Bachelor's Degree in Chemistry, Biochemistry, Biological Sciences, Engineering, or related science field.
• 3+ years of laboratory experience.
• 1-3 years GMP laboratory experience.

Responsibilities

• Execute physical and chemical analytical testing methods used in biological product manufacturing (chromatography, spectroscopy, electrophoresis, wet chemistry, glycan analysis, sub-visible particle analysis, peptide mapping, physical appearance).
• Ensure testing is performed according to GMP regulations and data is captured in LIMS with data integrity.
• Report assay performance and participate in CAPAs and improvements to quality and efficiency in QC Chemistry.

Skills

GMP experience

Analytical chemistry

Laboratory techniques

Education

Bachelor's in Chemistry or related field

Tools

LIMS software

Mass spectrometry

Job description

Fujifilm Biotechnologies in Holly Springs, NC is seeking a Senior Analyst 1, QC Chemistry to execute analytical methods across chromatography, spectroscopy, electrophoresis and other QC testing, ensuring GMP compliant operations. You will generate results, manage CAPAs, support analytical method transfers and validations, and train QC Chemistry staff.

Collaboration with Manufacturing, Process Science and QA is essential, with cross-functional objectives.