Analytical Method Transfer Scientist I — QC Chemistry

FUJIFILM Biotechnologies; Holly Springs (NC); On-site; USD 90,000 - 140,000; Full time

Job summary

FUJIFILM Biotechnologies in Holly Springs, NC, is seeking a Scientist 1, QC Analytical Development Chemistry to support GMP-compliant transfer of analytical methods for DS/DP into QC laboratories. You will author transfer documents, perform method transfers, and ensure compliance with ICH/FDA guidelines.

You will collaborate with QA, QC, and IT teams, prepare documentation, and support regulatory requests and inspections as part of TT/PPQ strategies globally.

Qualifications

• B.S. in Chemistry, Biochemistry, Biological Sciences, Engineering, or related field with 5+ years of analytical laboratory experience in biotech/pharma/CRO/CLO.
• M.S. in Chemistry, Biochemistry, Biological Sciences, Engineering, or related field with 3+ years of experience.
• Ph.D. in Chemistry, Biochemistry, Biological Sciences, Engineering, or related field with 1+ year 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 during project scoping.
• Participates in TT program meetings with cross-functional teams and stakeholders.
• Authors transfer and validation protocols/reports.
• Communicates with QC testing teams, QA, and Process Science to prioritize transfer activities by deadlines.
• Collaborates with LIMS and IT to build new analytical method functionality.

Skills

Analytical Chemistry

ICH Guidelines

Communication

Team Collaboration

Excel/Office Proficiency

GMP Knowledge

Education

B.S. in Chemistry/Biochemistry/Biological Sciences/Engineering or related field

M.S. in Chemistry/Biochemistry/Biological Sciences/Engineering or related field

Ph.D. in Chemistry/Biochemistry/Biological Sciences/Engineering or related field

Tools

LIMS

Job description

FUJIFILM Biotechnologies in Holly Springs, NC, is seeking a Scientist 1, QC Analytical Development Chemistry to support GMP-compliant transfer of analytical methods for DS/DP into QC laboratories. You will author transfer documents, perform method transfers, and ensure compliance with ICH/FDA guidelines.

You will collaborate with QA, QC, and IT teams, prepare documentation, and support regulatory requests and inspections as part of TT/PPQ strategies globally.