QC Chemistry Scientist I: GMP Analytics & Methods

FUJIFILM Biotechnologies; Holly Springs (NC); On-site; USD 90,000 - 120,000; Full time

Job summary

FUJIFILM Biotechnologies seeks a Scientist 1, QC Chemistry to perform QC analytical testing for biologics and support tech transfer in a GMP regime. You will work with GC, HPLC, UPLC, SEC, MS, UV/Vis, FTIR, icIEF, and other methods to ensure compliant results.

The role includes method qualification/validation support, deviation investigations, and collaborating with QA, Manufacturing, and Process Science teams to meet regulatory expectations.

Qualifications

• Bachelor’s degree with 5+ years of GMP analytical lab experience.
• Experience with chromatography and spectroscopy for biological products.
• Knowledge of validation, method transfer, and QC data review.

Responsibilities

• Perform QC analytical testing for biologics using GC/HPLC/UPLC/SEC and MS/UV/FTIR.
• Ensure GMP-compliant operation and data integrity.
• Review and approve analytical results, investigations, and CAPAs.

Skills

GMP compliance

Analytical chemistry

Chromatography

Spectroscopy

Documentation

Cross-functional collaboration

Education

Bachelor's in Chemistry or related field

Master's in Chemistry or related field

Ph.D. in Chemistry or related field

Job description

FUJIFILM Biotechnologies seeks a Scientist 1, QC Chemistry to perform QC analytical testing for biologics and support tech transfer in a GMP regime. You will work with GC, HPLC, UPLC, SEC, MS, UV/Vis, FTIR, icIEF, and other methods to ensure compliant results.

The role includes method qualification/validation support, deviation investigations, and collaborating with QA, Manufacturing, and Process Science teams to meet regulatory expectations.