QC Chemistry Analyst — GMP Biotech

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

Job summary

FUJIFILM Biotechnologies in Holly Springs, NC, seeks a Scientist 1, QC Chemistry to execute analytical methods (GC/HPLC/UPLC, MS, icIEF, glycan analysis) and ensure GMP-compliant operations in support of biological product manufacturing.

You will review data, contribute to transfers, SOPs, CAPAs, and cross-functional collaborations, while training team members and supporting audits and regulatory inspections.

Qualifications

• Bachelor’s in Chemistry, Biochemistry, Biological Sciences, Engineering, or related science with 5+ years in GMP environment.
• Analytical lab experience in biotechnology, Pharma, CRO, or CLO.

Responsibilities

• Perform physical and chemical analytical testing for biological products using GC/HPLC/UPLC/SEC and MS/UV/FTIR.
• Ensure testing conforms to GMP regulations for in-process, DS, DP, and stability samples.
• Review analytical data and support tech transfer and routine manufacturing.
• Participate in method qualification/validation and maintain lab equipment.
• Collaborate cross-functionally with QC, Manufacturing, Process Science, and QA.

Skills

Communication

English fluency

Analytical thinking

Project leadership

Data presentation

Team mentoring

Cross-functional collaboration

Detail oriented

Problem solving

Adaptability

Education

Bachelor’s in Chemistry or related field

Master’s in Chemistry or related field

PhD in Chemistry or related field

Tools

LIMS

Document management

CAPA system

Change control

Quality systems

Job description

FUJIFILM Biotechnologies in Holly Springs, NC, seeks a Scientist 1, QC Chemistry to execute analytical methods (GC/HPLC/UPLC, MS, icIEF, glycan analysis) and ensure GMP-compliant operations in support of biological product manufacturing.

You will review data, contribute to transfers, SOPs, CAPAs, and cross-functional collaborations, while training team members and supporting audits and regulatory inspections.