Senior QC Scientist – Analytical Method Validation

Genezen; Lexington (MA); On-site; USD 120,000 - 160,000; Full time

Benefits offered by this job

Paid vacation days

Paid sick time

401(k) with match

Healthcare plans

Job summary

Genezen in Lexington, MA seeks a QC Senior/Principal Scientist for Analytical Method Validation to lead transfer and validation of analytical methods for viral vectors, cell banks, and gene therapy products in our CDMO setting. You will work with analytical development, QC, manufacturing, and QA to ensure quality and regulatory compliance.

The role requires 8+ years in GLP/cGMP environments, strong statistical and documentation skills, and expertise in HPLC, qPCR/ddPCR, and cell-based assays.

Qualifications

• Ph.D or MS in Molecular Biology/Biochemistry or related Life Sciences.
• 8+ years analytical lab experience in GLP/cGMP environment, with method validation/transfer.
• Experience with QC instrument qualification is preferred.

Responsibilities

• Lead transfer and validate analytical methods for viral vectors, cell banks, and gene therapy products.
• Support cGMP operations; generate documentation for change controls, CAPAs, deviations, and investigations.
• Provide coaching and training for QC scientists and contribute to technical development.
• Lead training of new analytical methods and support QC analysts in data analysis and review.
• Ensure current laboratory procedures and regulatory compliance.

Skills

Analytical method validation

Transfer of methods

Statistical analysis

GMP/cGMP knowledge

HPLC

qPCR/ddPCR

Cell-based bioassays

Documentation writing

Education

Ph.D or MS in Life Sciences

Tools

MS Word

Excel

JMP / Minitab

LIMS

Job description

Genezen in Lexington, MA seeks a QC Senior/Principal Scientist for Analytical Method Validation to lead transfer and validation of analytical methods for viral vectors, cell banks, and gene therapy products in our CDMO setting. You will work with analytical development, QC, manufacturing, and QA to ensure quality and regulatory compliance.

The role requires 8+ years in GLP/cGMP environments, strong statistical and documentation skills, and expertise in HPLC, qPCR/ddPCR, and cell-based assays.