QC Chemistry Specialist – GMP & Method Expert

FUJIFILM; Holly Springs (AL); On-site; USD 95,000 - 125,000; Full time

Job summary

FUJIFILM Biotechnologies in Holly Springs, NC, seeks a Scientist 1, QC Chemistry to perform QC analytical testing on biological products, including chromatography (GC, HPLC, UPLC, SEC), spectroscopy (MS, LC-MS/MS, UV), icIEF, glycan analysis, and particle analysis. Ensure GMP-compliant operations and approve results.

You will develop and review SOPs, support tech transfer and routine manufacturing, provide training, and collaborate across QC, Manufacturing, Process Science, and QA.

Qualifications

• Bachelor’s in Chemistry, Biochemistry, Biological Sciences, Engineering, or related science field with 5+ years of experience; OR Master’s with 3+ years; OR PhD with 1+ year.
• GMP-regulated laboratory experience in biotechnology, pharma, CRO or CLO.
• Experience with physical/chemical analytical methods (GC, HPLC, UPLC, SEC; MS; UV/Vis; FTIR; icIEF; etc.).

Responsibilities

• Perform physical and chemical analytical testing for biological products per GMP.
• Ensure testing of DS/DP/stability samples per GMP regulations.
• Peer review analytical data and support tech transfer and manufacturing.
• Validate methods and maintain laboratory equipment.
• Draft and review SOPs, CAPAs, deviations, and change controls.
• Collaborate across QC, Manufacturing, Process Science and QA.

Skills

English communication

Oral and written communication

Project leadership

Data analysis

Cross-functional collaboration

Attention to detail

Independent work

Education

Bachelor’s in Chemistry or related field

Master’s in Chemistry or related field

PhD in Chemistry or related field

Tools

LIMS

TrackWise

Job description

FUJIFILM Biotechnologies in Holly Springs, NC, seeks a Scientist 1, QC Chemistry to perform QC analytical testing on biological products, including chromatography (GC, HPLC, UPLC, SEC), spectroscopy (MS, LC-MS/MS, UV), icIEF, glycan analysis, and particle analysis. Ensure GMP-compliant operations and approve results.

You will develop and review SOPs, support tech transfer and routine manufacturing, provide training, and collaborate across QC, Manufacturing, Process Science, and QA.