QC Chemistry Scientist I - GMP Analytics & Tech Transfer

FUJIFILM Electronic Materials (Europe) N.V.; Holly Springs (NC); On-site; USD 85,000 - 110,000; Full time

Job summary

FUJIFILM Biotechnologies in Holly Springs, NC is seeking a Scientist 1, QC Chemistry to perform analytical testing (GC, HPLC, LC-MS, icIEF, UV/Vis) on biologics, ensure GMP compliance, and review results.

You will participate in tech transfer, method qualification, CAPA investigations, and cross-functional QA/Manufacturing collaborations, while mentoring junior staff and supporting 24/7 operations.

Qualifications

• Bachelor’s degree with 5+ years of analytical lab experience or higher degrees with applicable experience in GMP environments.
• Experience with analytical testing methods common to biotech/pharma and regulated labs.
• Knowledge of GMP, quality systems, and method qualification/validation.

Responsibilities

• Performs physical and chemical analytical testing for biological products using GC, HPLC, UPLC, SEC, MS, GC/MS, LC-MS/MS, UV, UV-Vis, FTIR.
• Ensures GMP-compliant testing of in-process samples, DS/DP, and stability studies.
• Performs data reviews and peer reviews of analytical results for tech transfer and manufacturing.
• Executes method qualification/validation and maintains lab equipment.
• Monitors assay performance and implements quality improvements.
• Investigates deviations, invalid assays, OOS/OOT, and CAPAs.
• Authors/reviews SOPs, change controls, Trackwise items, and CAPA documentation.
• Collaborates with QC, Manufacturing, Process Science, and QA to meet objectives.
• Provides training and SME support during audits and customer visits.
• Supports risk assessments and cross-functional projects as needed.

Skills

English fluency

Communication skills

Detail oriented

Project leadership

Data analysis

Cross functional collaboration

Independent work

Mentor others

Problem solving

Planning skills

Education

Bachelor’s in Chemistry or related

Master’s in Chemistry or related

PhD in Chemistry or related

Job description

FUJIFILM Biotechnologies in Holly Springs, NC is seeking a Scientist 1, QC Chemistry to perform analytical testing (GC, HPLC, LC-MS, icIEF, UV/Vis) on biologics, ensure GMP compliance, and review results.

You will participate in tech transfer, method qualification, CAPA investigations, and cross-functional QA/Manufacturing collaborations, while mentoring junior staff and supporting 24/7 operations.