Analytical Systems & Validation Specialist - Pharma QC

Novartis; Morristown (VT); On-site; USD 90,000 - 166,000; Full time

Job summary

Novartis is seeking an AS&T Specialist to support the Morrisville site’s analytical quality control capabilities. You will lead method validation, transfer, and lifecycle management for pharmaceutical materials, ensuring data integrity and regulatory compliance.

In this role, you will own lab equipment qualification, support investigations, and work with cross-functional teams to enable product transfers and site readiness.

Qualifications

• Bachelor’s degree in a related scientific discipline with 5+ years in a cGMP lab environment.
• Hands-on experience with HPLC, UPLC, GC, LC-MS, ICP spectroscopy, dissolution, or related tests.
• Experience with LabWare LIMS and Empower CDS.
• Knowledge of ICH Q2/Q7/Q10 and data integrity principles.
• Ability to troubleshoot analytical methods and instruments in a compliant setting.
• Strong communication and collaboration across cross-functional teams.

Responsibilities

• Execute analytical method validation, transfer, optimization, and lifecycle management.
• Provide technical support for investigations, including OOS, deviations, root cause analysis, CAPA.
• Own analytical lab equipment qualification, calibration, and maintenance programs.
• Lead qualification and implementation activities for new analytics tech and startup readiness.
• Perform complex testing using HPLC, UPLC, GC, LC-MS, ICP, dissolution, and related methods.
• Prepare and maintain protocols, reports, specifications, SOPs, and technical records per GxP.
• Support product transfers, validation programs, and new methods rollout.
• Ensure compliance with cGxP, data integrity, and regulatory standards.

Skills

Analytical troubleshooting

Cross-functional collaboration

Problem-solving

Good documentation practices

Education

Bachelor’s degree in Chemistry, Pharmacy, Microbiology, or related field

Tools

LabWare LIMS

Empower CDS

Job description

Novartis is seeking an AS&T Specialist to support the Morrisville site’s analytical quality control capabilities. You will lead method validation, transfer, and lifecycle management for pharmaceutical materials, ensuring data integrity and regulatory compliance.

In this role, you will own lab equipment qualification, support investigations, and work with cross-functional teams to enable product transfers and site readiness.