Analytical Scientist - Pharma QC & Method Validation

Novartis Group Companies; Morrisville (NC); On-site; USD 90,000 - 166,000; Full time

Benefits offered by this job

Health insurance

Job summary

Novartis Group Companies in Morrisville, NC seeks an AS&T Specialist to support analytical method validation, transfers, investigations, and equipment qualification across its small molecule QC laboratory. You will enable lifecycle management of methods and technologies for testing raw materials, intermediates, and finished products.

The role emphasizes cGMP compliance, data integrity, and cross-functional collaboration to ensure readiness for transfer and commercial testing activities.

Qualifications

• Bachelor's degree in Chemistry, Pharmacy, Microbiology or related scientific discipline with 5+ years in a cGMP lab.
• Hands-on experience with complex analytical techniques and instrumentation (HPLC/UPLC/GC/LC-MS/ICP/dissolution).
• Experience with LabWare LIMS and Empower CDS.

Responsibilities

• Execute analytical method validation, transfer, optimization and lifecycle management for pharmaceutical materials.
• Provide scientific support for investigations including OOS/deviations and CAPA development.
• Lead equipment qualification, calibration, maintenance and startup readiness.
• Perform complex analytical testing using HPLC, UPLC, GC, LC-MS, ICP and dissolution methods.
• Author and maintain documentation per GxP requirements.

Skills

HPLC

UPLC

GC

LC-MS

ICP spectroscopy

dissolution

physicochemical testing

data integrity

GxP

troubleshooting

Education

Bachelor's degree in Chemistry/Pharmacy/Microbiology

Tools

LabWare LIMS

Empower CDS

Job description

Novartis Group Companies in Morrisville, NC seeks an AS&T Specialist to support analytical method validation, transfers, investigations, and equipment qualification across its small molecule QC laboratory. You will enable lifecycle management of methods and technologies for testing raw materials, intermediates, and finished products.

The role emphasizes cGMP compliance, data integrity, and cross-functional collaboration to ensure readiness for transfer and commercial testing activities.