QC Senior/Principal Scientist, Analytical Method Validation

Responsibilities

• Lead transfer and validation of next-generation analytical procedures for viral vectors, cell banks, and gene therapy products
• Act as SME for cell-based and analytical method protocols, reports, and validation
• Perform statistical analyses of data generated during method validation and qualification studies
• Monitor analytical method performance and system suitability requirements
• Support cGMP operations including change controls, deviations, OOS investigations, and assay troubleshooting
• Provide coaching and technical development to QCTS scientists
• Lead training of new analytical methods and support QC analysts on execution and data review
• Identify and lead continuous improvements to processes and procedures

Requirements

• Ph.D or MS in Molecular Biology, Biochemistry, or related Life Sciences
• Minimum 8 years of analytical laboratory experience in GLP/cGMP environments
• Proven experience with analytical method validation and transfer
• Experience with analytical data trending and statistical analysis
• Proficiency with technical writing (protocols, reports, procedures)
• Familiarity with ICH, FDA, and EMA guidance documents relevant to gene/cell therapy
• Working knowledge of quality systems requirements
• Proficiency in MS Word, Excel, JMP, Minitab, and LIMS

Preferred Qualifications

• Experience with cell-based bioassays using mammalian cell-lines (HELA, HEK-293, Huh-7, etc.)
• Understanding of QC instrument qualification

About the Company

Genezen provides process development, GMP viral vector production, and cell transduction for gene and cell therapy clinical trials to help lead to new cures.