Senior QC Analytical Development Chemist

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

Job summary

FUJIFILM Biotechnologies Holly Springs seeks a Senior Analyst 1, QC AD Chemistry to support analytical method transfers and validations for drug substance and drug product into QC laboratories. The role emphasizes GMP compliance and collaborative execution with cross-functional teams.

The candidate will author and review SOPs, protocols, and technical reports, while coordinating with CLOs, QA, and Process Science to ensure timely method transfers and regulatory readiness.

Qualifications

• Knowledge of cGMPs, ICH, FDA, USP, EP requirements related to analytical methods.
• Experience with analytical methods in biopharma including chromatography, spectroscopy, and electrophoresis.
• Ability to write deviations, CAPA, and scientific reports.
• Proficient with MS Office products and data analysis tools.

Responsibilities

• Executes verification, transfer, and validation of analytical methods (GC, HPLC, UPLC, SEC; MS, LC-MS/MS; UV/Vis; FTIR).
• Authors and reviews SOPs, protocols, and technical reports.
• Supports cross-functional teams (CLOs, QA, Process Science) to ensure method transfer according to deadlines.
• Collaborates with LIMS and IT to build new method functionalities.
• Ensures regulatory readiness and compliance (ICH, FDA) for TT programs.
• Trains QC Chemistry lab associates and supports investigations.

Skills

GMP knowledge

Analytical method transfer

Cross-functional collaboration

Strong written communication

MS Office

Education

Bachelor's degree in Chemistry, Biology, or related field

Master's degree in Biology, Chemistry, Biochemistry, or related field

Tools

LIMS software

Job description

FUJIFILM Biotechnologies Holly Springs seeks a Senior Analyst 1, QC AD Chemistry to support analytical method transfers and validations for drug substance and drug product into QC laboratories. The role emphasizes GMP compliance and collaborative execution with cross-functional teams.

The candidate will author and review SOPs, protocols, and technical reports, while coordinating with CLOs, QA, and Process Science to ensure timely method transfers and regulatory readiness.