QC Analytical Development Chemist – Method Transfer & GMP

Merck & Co.; 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 for QC Analytical Development Chemistry to support transfer of analytical methods into QC labs. You will ensure GMP-compliant operations and author transfer documents for methods such as HPLC/UPLC, CE-SDS, icIEF, and UVA280.

The role requires collaboration with program management, QC, QA, and IT teams to meet TT/PPQ milestones, and to support regulatory requests and inspections.

Qualifications

• Bachelor’s or higher in chemistry/biochemistry/biological sciences with 5+ years of analytical lab experience.
• Experience with analytical method transfers.
• 3+ years in a regulated GMP environment; method development, transfer, and validation.

Responsibilities

• Support TT method transfer, verification, and validation.
• Interface with customers and program management to identify analytical needs and method gaps.
• Authors technical documents including transfer and validation protocols/reports.
• Collaborate with QC, QA, and Process Science to prioritize transfers per deadlines.
• Work with LIMS/IT to build new analytical method functionality.
• Ensure compendial method oversight per ICH/EMA/FDA guidelines.
• Support regulatory requests and inspections.

Skills

Analytical Chemistry

ICH guidelines

Communication

GMP knowledge

Excel

LIMS

Education

B.S. in Chemistry

M.S. in Chemistry

Ph.D. in Chemistry

Tools

HPLC/UPLC

icIEF

CE-SDS

UVA280

LIMS

Job description

Fujifilm Biotechnologies in Holly Springs, NC is seeking a Scientist 1 for QC Analytical Development Chemistry to support transfer of analytical methods into QC labs. You will ensure GMP-compliant operations and author transfer documents for methods such as HPLC/UPLC, CE-SDS, icIEF, and UVA280.

The role requires collaboration with program management, QC, QA, and IT teams to meet TT/PPQ milestones, and to support regulatory requests and inspections.