Senior QC Analyst – Methods & Validation

U473 (FCRS = US473) Novartis Gene Therapies; Morrisville (NC); On-site; USD 90,000 - 166,000; Full time

Benefits offered by this job

Health benefits

401(k) match

Generous time off

Job summary

Novartis Gene Therapies in Morrisville, NC seeks a QC Specialist II to lead complex analytical testing within a GMP environment. You will support method transfers, validation, data review, and investigations, providing technical leadership across QC and MS&T teams.

The role requires advanced chromatography experience (HPLC/UPLC/LC-MS), instrument qualification, and cGMP compliance, with a focus on data integrity and regulatory readiness at a growing site.

Qualifications

• Advanced chromatography and analytical testing experience in a cGMP environment.
• Experience with method transfers, validation, troubleshooting, and lifecycle management.

Responsibilities

• Serve as SME for analytical techniques and instrumentation (HPLC/UPLC/GC/LC-MS).
• Perform chromatographic and wet-chemistry testing of materials and products per GLP/cGMP.
• Lead method transfers, validation, troubleshooting, risk mitigation, and investigations.

Skills

HPLC

UPLC

LC-MS

GC

Chromatography

Education

Bachelor's degree in Chemistry/Analytical Chemistry/Pharmaceutical Sciences

Tools

LabWare LIMS

Empower CDS

Job description

Novartis Gene Therapies in Morrisville, NC seeks a QC Specialist II to lead complex analytical testing within a GMP environment. You will support method transfers, validation, data review, and investigations, providing technical leadership across QC and MS&T teams.

The role requires advanced chromatography experience (HPLC/UPLC/LC-MS), instrument qualification, and cGMP compliance, with a focus on data integrity and regulatory readiness at a growing site.