AS&T Specialist

Summary

Location:

Morrisville, North Carolina

The AS&T Specialist will play a critical role in supporting the start-up and growth of Novartis' Small Molecules Quality Control laboratory in Morrisville, North Carolina. This position provides scientific analytical support across method validation, method transfer, analytical troubleshooting, equipment qualification, and commercial testing activities while ensuring the highest standards of quality, compliance, and data integrity.

Working within a growing site organization, the AS&T Specialist will support the implementation and lifecycle management of analytical methods, technologies, and laboratory equipment used to test pharmaceutical raw materials, intermediates, and finished products. The role will contribute to equipment qualification, calibration, maintenance, and technology implementation activities while partnering with cross-functional teams to support product transfers and laboratory readiness.

This is an exciting opportunity to help build the analytical capabilities and laboratory infrastructure supporting the future growth of the Morrisville manufacturing site.

• Execute analytical method validation, transfer, optimization, and lifecycle management activities supporting pharmaceutical raw materials, intermediates, and finished products.
• Provide scientific and technical support for analytical investigations, including OOS results, deviations, root cause analysis, troubleshooting activities, and CAPA development.
• Serve as a technical owner for analytical laboratory equipment, coordinating qualification, calibration, maintenance, lifecycle management, and performance monitoring activities to ensure reliable and compliant laboratory operations.
• Lead equipment qualification and implementation activities, including qualification planning, computerized system validation (CSV) support, introduction of new analytical technologies, and readiness activities associated with laboratory start-up and expansion.
• Perform and support complex analytical testing utilizing technologies such as HPLC, UPLC, GC, LC-MS, ICP spectroscopy, dissolution, and physicochemical testing techniques.
• Author, review, and maintain analytical documentation, including protocols, reports, specifications, SOPs, investigations, qualification documentation, and technical records in accordance with GxP requirements.
• Support product transfers, validation programs, and implementation of new analytical methods and technologies required to advance the Morrisville site and future manufacturing operations.
• Ensure compliance with cGxP, data integrity, regulatory, and Novartis quality standards while supporting audits, inspections, commercial release testing, and continuous improvement initiatives.

• Bachelor's degree in Chemistry, Pharmacy, Microbiology, or another related scientific discipline with a minimum of 5 years of experience working in a cGMP laboratory environment supporting pharmaceutical or biotechnology operations.
• Hands‑on experience with complex analytical techniques and instrumentation, including HPLC, UPLC, GC, LC‑MS, ICP spectroscopy, dissolution, and/or physicochemical testing.
• Experience using Lab Ware LIMS and familiarity with building methods and utilizing Empower CDS.
• Working knowledge of ICH Q2, ICH Q7, ICH Q10, GxP requirements, data integrity principles, and good documentation practices.
• Demonstrated ability to troubleshoot analytical methods and laboratory instrumentation while supporting compliant laboratory operations and scientific investigations.
• Strong communication, collaboration, and problem‑solving skills, with the ability to identify key issues, adapt to changing priorities, and work effectively across…