Lead Analytical Methods Specialist

Novartis

Morrisville (NC)

On-site

USD 100,000 - 166,000

Full time

2 days ago

Be an early applicant

Application generator

A complete application in a minute — tailored resume and cover letter, ready to send.

Get past ATS filters

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.