QC Compendial Testing Scientist – Tech Transfer & Release

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

Job summary

FUJIFILM Biotechnologies in Holly Springs seeks a Scientist 1 for QC Compendial Testing to support technology transfer and the onboarding of materials. The role includes evaluating vendor documentation, performing material assessments, and ensuring testing aligns with cGMP and GDP practices.

You will lead material transfer activities, author procedures, and support TT timelines while maintaining an integrity of laboratory results and documentation across transfers and validation efforts.

Qualifications

• Bachelor’s degree in Chemistry, Biology, Microbiology, Biochemistry or other relevant scientific discipline with 5 years of applicable industry experience; OR, Master’s degree with 3+ years; OR, Ph.D. with no years of experience.
• Experience with compendial testing methodology as it pertains to cGMP.
• Experience with method transfers.

Responsibilities

• Performs as SME in designated methods transferred into FUJIFILM Biotechnologies, Holly Springs.
• Coordinates release/sampling and chemical analysis of materials; prepares monthly metrics.
• Represents QC Compendial Testing in TT meetings for new products and changes.

Skills

Analytical skills

GMP/GLP knowledge

Project management

Team collaboration

Documentation

Education

Bachelor’s degree in Chemistry or related science

Master’s degree in Chemistry or related science

Ph.D. in Chemistry or related field

Job description

FUJIFILM Biotechnologies in Holly Springs seeks a Scientist 1 for QC Compendial Testing to support technology transfer and the onboarding of materials. The role includes evaluating vendor documentation, performing material assessments, and ensuring testing aligns with cGMP and GDP practices.

You will lead material transfer activities, author procedures, and support TT timelines while maintaining an integrity of laboratory results and documentation across transfers and validation efforts.