Senior QC Analytical Development Chemist - Method Transfers

FUJIFILM Biotechnologies; Holly Springs (NC); On-site; USD 80,000 - 110,000; Full time

Job summary

FUJIFILM Biotechnologies in Holly Springs, NC seeks a Senior Analyst 1, QC Analytical Development (AD Chemistry) to execute method transfers and validations for drug substance and drug product manufacturing. The role requires collaboration with QC, QA, and Process Science teams to ensure compliance and timely delivery.

The candidate will author and review SOPs and technical reports, work with cross-functional teams, and support regulatory responses while adhering to cGMPs in a fast-paced

Qualifications

• Requires degree with 2+ years GMP lab experience.
• Experience with analytical methods (GC/HPLC/UPLC, MS, CE-SDS).
• Ability to work with limited supervision in a fast-paced environment.

Responsibilities

• Executes verification, transfer, and validation of analytical chemistry methods including GC/HPLC/UPLC, MS, CE-SDS, UV, FTIR, glycan analysis, and other assays.
• Ensures compliance with cGMP and regulatory guidelines.
• Authors and reviews SOPs, protocols, and technical reports.
• Collaborates with CLOs, QC teams, QA, and Process Science groups to transfer methods.
• Supports regulatory requests and inspections.
• Provides training to QC Chemistry lab associates.

Skills

cGMPs knowledge

MS Office proficiency

Strong communication

Cross-functional collaboration

Technical writing

Education

Bachelor's degree in Chemistry

Master's degree in Chemistry/Biochemistry

Tools

LIMS software

Job description

FUJIFILM Biotechnologies in Holly Springs, NC seeks a Senior Analyst 1, QC Analytical Development (AD Chemistry) to execute method transfers and validations for drug substance and drug product manufacturing. The role requires collaboration with QC, QA, and Process Science teams to ensure compliance and timely delivery.

The candidate will author and review SOPs and technical reports, work with cross-functional teams, and support regulatory responses while adhering to cGMPs in a fast-paced