Senior QC Analytical Development Chemist - Method Transfers

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

Job summary

FUJIFILM Biotechnologies Holly Springs seeks a Senior Analyst 1, QC Analytical Development (AD Chemistry) to support analytical method transfers and validations for drug substance and drug product manufacturing in QC laboratories. This role ensures GMP-compliant operations and partners with CLOs, QC, QA, and Process Science to meet deadlines.

The incumbent authors and reviews SOPs, protocols, and technical reports, and collaborates with IT and LIMS teams to enhance analytical capabilities.

Qualifications

• B.A./B.S. in Chemistry, Biology, Microbiology, Biochemistry or other relevant scientific discipline with 2+ years of experience; OR,
• Masters degree in biology, Chemistry Biochemistry, Microbiology or other relevant scientific discipline with 0 years’ 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, spectroscopy, electrophoresis, wet chemistry, glycan analysis, sub-visible particle analysis, peptide mapping, and physical appearance, etc.

Responsibilities

• Executes verification, transfer, and validation of analytical chemistry methods including chromatography (GC, HPLC, UPLC, SEC), spectroscopy (MS, GC/MS, LC-MS/MS, UV, UV-Vis, FTIR).
• Authors and reviews SOPs, protocols, and technical reports.
• Works cross-functionally with CLOs, QC testing teams, QA, and Process Science groups to ensure transfer of methods according to deadlines.
• Collaborates with the LIMS team and IT department to build new analytical method functionality.
• Supports regulatory requests and inspections.

Skills

cGMPs knowledge

Regulatory knowledge

Technical writing

Communication skills

Problem solving

Cross-functional collaboration

Ability to work with minimal supervis

Education

B.A./B.S. in Chemistry or related

Master's degree in biology/chemistry/biochemistry/microbiology

Tools

LIMS

Microsoft Office

Job description

FUJIFILM Biotechnologies Holly Springs seeks a Senior Analyst 1, QC Analytical Development (AD Chemistry) to support analytical method transfers and validations for drug substance and drug product manufacturing in QC laboratories. This role ensures GMP-compliant operations and partners with CLOs, QC, QA, and Process Science to meet deadlines.

The incumbent authors and reviews SOPs, protocols, and technical reports, and collaborates with IT and LIMS teams to enhance analytical capabilities.