Lead Analytical Methods Specialist

Novartis; Morrisville (NC); On-site; USD 100,000 - 166,000; Full time

Job summary

Novartis in Morrisville, NC seeks an AS&T Specialist to support startup and growth of the Small Molecules Quality Control laboratory. You will provide analytical support across method validation, method transfer, troubleshooting, equipment qualification, and routine testing to uphold cGMP data integrity.

The role partners with cross-functional teams to qualify equipment, implement new technologies, and enable product transfers.

Qualifications

• Minimum 5 years in a cGMP laboratory supporting pharmaceutical/biotech operations.
• Hands-on with complex analytical techniques (HPLC/UPLC/GC/LC-MS/ICP and dissolution).
• Familiar with LabWare LIMS and Empower CDS; knowledge of GxP and data integrity.

Responsibilities

• Execute analytical method validation, transfer, optimization, and lifecycle management.
• Provide support for investigations, deviations,Root Cause Analysis, and CAPA.
• Own analytical lab equipment qualification, calibration, maintenance, and monitoring.
• Lead qualification and implementation activities, CSV support, and tech introductions.
• Perform complex testing with HPLC/UPLC/GC/LC-MS/ICP, dissolution, and related tests.
• Prepare and review protocols, reports, specs, SOPs, investigations, and validation docs.
• Support product transfers, method validation programs, and new technology adoption.
• Ensure cGxP compliance, data integrity, audits, and continuous improvement.

Skills

cGMP laboratory experience

Analytical method troubleshooting

Cross-functional collaboration

Strong communication skills

Education

Bachelor's degree in Chemistry, Pharmacy, Microbiology, or related

Tools

LabWare LIMS

Empower CDS

Job description

Novartis in Morrisville, NC seeks an AS&T Specialist to support startup and growth of the Small Molecules Quality Control laboratory. You will provide analytical support across method validation, method transfer, troubleshooting, equipment qualification, and routine testing to uphold cGMP data integrity.

The role partners with cross-functional teams to qualify equipment, implement new technologies, and enable product transfers.