Senior QC Analytical Development Chemist

FUJIFILM Electronic Materials (Europe) N.V.; Holly Springs (NC); On-site; USD 80,000 - 110,000; Full time

Job summary

FUJIFILM Biotechnologies Holly Springs seeks a Senior Analyst 1, QC AD Chemistry to support analytical method transfers and validations for DS/DP manufacturing in QC labs. You will work with chromatography, spectroscopy, electrophoresis, glycan analysis, and other analytical techniques, ensuring GMP compliance and timely delivery of technical reports.

The role requires collaboration with QA, IT, CLOs, and Process Science teams to transfer methods, author SOPs, and support regulatory inspections.

Qualifications

• Minimum 2+ years in GMP laboratory settings.
• Experience with analytical methods used in biotech.
• Strong written and verbal communication.

Responsibilities

• Execute transfers, verifications, and validations of analytical methods.
• Authors/reviews SOPs, protocols, and technical reports.
• Collaborate across QA, QC, and IT for method improvements.
• Ensure adherence to ICH/FDA guidelines and GMP.
• Support regulatory inquiries and inspections.

Skills

Communication

Cross-functional

Attention to detail

Technical writing

Problem solving

Education

BS in Chemistry/Biology

MS in Biochemistry/Chemistry

Tools

LIMS software

Job description

FUJIFILM Biotechnologies Holly Springs seeks a Senior Analyst 1, QC AD Chemistry to support analytical method transfers and validations for DS/DP manufacturing in QC labs. You will work with chromatography, spectroscopy, electrophoresis, glycan analysis, and other analytical techniques, ensuring GMP compliance and timely delivery of technical reports.

The role requires collaboration with QA, IT, CLOs, and Process Science teams to transfer methods, author SOPs, and support regulatory inspections.