QC Analytical Development Chemist - Method Transfer

Socket.dev; Holly Springs (NC); On-site; USD 90,000 - 120,000; Full time

Job summary

FUJIFILM Biotechnologies in Holly Springs, NC, seeks a Scientist 1, QC Analytical Development Chemistry to support transfer of analytical methods for DS/DP into QC labs, ensuring GMP-compliant operations and regulatory adherence.

The role involves authoring transfer documents, executing testing, and collaborating with cross-functional teams to prioritize method transfer activities and meet deadlines.

Qualifications

• S. in Chemistry, Biochemistry, Biological Sciences, Engineering, or related field with 5+ years of analytical lab experience.
• Experience with analytical method transfers and GMP environments.
• Proficient with analytical techniques including HPLC/UPLC, CE-SDS, icIEF, and UV spectroscopy.

Responsibilities

• Supports analytical chemistry method tech transfer and execution through verification, transfer, and validation.
• Interacts with customers and program management to identify analytical needs and gaps.
• Authors technical documents including transfer and validation reports.
• Communicates with QC testing teams, QA, and Process Science to prioritize transfers.
• Collaborates with LIMS and IT to build new method functionality meeting end-user needs.
• Ensures compendial method oversight and regulatory guidelines (ICH, EMA, FDA).
• Supports regulatory requests and inspections and TT/PPQ strategies globally.

Skills

Analytical chemistry

ICH guidelines

GMP knowledge

Cross-functional collaboration

Data interpretation

Education

BS/MS in Chemistry/Biochemistry/Biology/Engineering

PhD in Chemistry/Biochemistry/Biological Sciences/Engineering

GMP laboratory experience

Tools

LIMS

Job description

FUJIFILM Biotechnologies in Holly Springs, NC, seeks a Scientist 1, QC Analytical Development Chemistry to support transfer of analytical methods for DS/DP into QC labs, ensuring GMP-compliant operations and regulatory adherence.

The role involves authoring transfer documents, executing testing, and collaborating with cross-functional teams to prioritize method transfer activities and meet deadlines.