QC Analytical Development Scientist I

FUJIFILM Biotechnologies; Holly Springs (NC); On-site; USD 85,000 - 120,000; Full time

Job summary

Fuji Film Biotechnologies in Holly Springs, North Carolina, seeks a Scientist 1, QC Analytical Development Chemistry to support the transfer of analytical methods into QC laboratories, ensuring GMP-compliant operations under regulatory guidelines.

The role involves authoring transfer documents, executing testing, and collaborating with cross-functional teams to ensure timely, compliant method transfer across TT programs and regulatory interactions.

Qualifications

• Experience with analytical method transfers.
• Experience in GMP-regulated environment.
• Strong data analysis and interpretation skills.
• Proven project management experience.
• Proficient in MS Office and data reporting.

Responsibilities

• Supports analytical chemistry method transfer and validation.
• Interfaces with customers and program management to identify analytical needs.
• Authors transfer and validation protocols/reports.
• Ensures compliance with ICH, EMA, FDA guidelines and regulatory requirements.

Skills

Analytical Chemistry

ICH Guidelines

GMP Compliance

Data Analysis

Excel/Office

Communication

Education

Bachelor's degree in Chemistry/related

Doctorate in Chemistry/related

Tools

HPLC/UPLC

icIEF

Capillary Electrophoresis

LIMS

Job description

Fuji Film Biotechnologies in Holly Springs, North Carolina, seeks a Scientist 1, QC Analytical Development Chemistry to support the transfer of analytical methods into QC laboratories, ensuring GMP-compliant operations under regulatory guidelines.

The role involves authoring transfer documents, executing testing, and collaborating with cross-functional teams to ensure timely, compliant method transfer across TT programs and regulatory interactions.