Analytical Development QC Scientist I

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

Job summary

FUJIFILM Biotechnologies in Holly Springs, NC is seeking a Scientist 1, QC Analytical Development Chemistry to support technology transfer of analytical methods into the Quality Control laboratories, ensuring GMP-compliant operations and regulatory compliance.

You will author transfer and validation documents, perform testing on HPLC/UPLC, UV, CE-SDS, icIEF, and collaborate with QA, IT, and LIMS teams to enable successful method transfers and regulatory support.

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.
• Experience with analytical method transfers.
• Experience with project management and demonstrated ability for providing regular updates and escalations.
• Proficient in physical and chemical testing methods for biological products, including HPLC/UPLC chromatography (Protein A/G titer, SEC, PS80, glycans, peptide map); UVA280 and slope spectroscopy; capillary electrophoresis (CE-SDS, icIEF); general pharmaceutical properties methods.
• 3+ years of experience working in a regulated GMP environment.
• Relevant experience in analytical method development, transfer, and validation.

Responsibilities

• Supports analytical chemistry method tech transfer and execution through method verification, transfer, and validation.
• Interfaces with customers and program management to identify analytical needs and method gaps during project scoping.
• Participates in meetings for TT programs 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 non-compendial and compendial method transfer activities according to deadlines.
• Collaborates with the LIMS team and IT department to build new analytical method functionality that meets end-user and customer requirements.
• Ensures compendial method oversight and scientific guidelines (e.g. ICH, EMA, FDA, etc.).
• Supports regulatory requests and inspections.
• Supports the QCAD team to investigate any project challenges with necessary risk assessment tools and techniques.
• Supports best practices for TT and PPQ strategies globally, as required.
• Performs other duties, as assigned.

Skills

Analytical Chemistry

ICH Guidelines

Communication

GMP Knowledge

Excel Proficiency

Education

MS in Chemistry

BS in Biochemistry

PhD in Chemistry

Tools

LIMS

HPLC/UPLC

icIEF

CE-SDS

Job description

FUJIFILM Biotechnologies in Holly Springs, NC is seeking a Scientist 1, QC Analytical Development Chemistry to support technology transfer of analytical methods into the Quality Control laboratories, ensuring GMP-compliant operations and regulatory compliance.

You will author transfer and validation documents, perform testing on HPLC/UPLC, UV, CE-SDS, icIEF, and collaborate with QA, IT, and LIMS teams to enable successful method transfers and regulatory support.