QC Analytical Development Chemist – Method Transfer

FUJIFILM Holdings America Corporation; Holly Springs (NC); On-site; USD 90,000 - 130,000; Full time

Job summary

FUJIFILM Biotechnologies in Holly Springs, NC seeks a Scientist 1 in QC Analytical Development Chemistry to support transfer of analytical methods for DS/DP into QC laboratories. The role ensures GMP-aligned lab operations and authors transfer documents, executing testing as part of transfers for HPLC/UPLC, UVA280, CE-SDS, icIEF and other methods.

The candidate should have strong knowledge of analytical chemistry, ICH guidelines, and experience in GMP environments, with ability to communicate

Qualifications

• S. in Chemistry, Biochemistry, Biological Sciences, Engineering, or related science field with 5+ years of analytical laboratory experience preferably in biotechnology, Pharma, CRO, or CLO; OR,
• S. in Chemistry, Biochemistry, Biological Sciences, Engineering, or related science field with 3+ years of experience; OR,
• D. in Chemistry, Biochemistry, Biological Sciences, Engineering, or related science field with 1+ years of experience.

Responsibilities

• Supports analytical chemistry method tech transfer and execution through verification, transfer, and validation.
• Interfaces with customers and program management to identify analytical needs and method gaps.
• Participates in TT program meetings with cross-functional teams and key stakeholders.
• Authors technical documents including transfer and validation protocols/reports.
• Communicates with QC testing teams, QA, and Process Science groups to ensure prioritization of method transfer activities.
• Collaborates with the LIMS team and IT department to build new analytical method functionality.
• Ensures compendial method oversight and scientific guidelines (ICH, EMA, FDA).
• Supports regulatory requests and inspections.

Skills

Analytical Chemistry

GMP knowledge

Data analysis

Communication skills

Office software

Education

BS/MS/PhD in Chemistry/Biochemistry/Biology/Engineering or related science

5+ years analytical lab experience

1–3+ years in GMP environment (varies)

Tools

LIMS

IT systems

HPLC/UPLC instruments

Job description

FUJIFILM Biotechnologies in Holly Springs, NC seeks a Scientist 1 in QC Analytical Development Chemistry to support transfer of analytical methods for DS/DP into QC laboratories. The role ensures GMP-aligned lab operations and authors transfer documents, executing testing as part of transfers for HPLC/UPLC, UVA280, CE-SDS, icIEF and other methods.

The candidate should have strong knowledge of analytical chemistry, ICH guidelines, and experience in GMP environments, with ability to communicate