AS&T Specialist
Novartis
August 29, 2026
On-site
Morrisville, NC
IT
Key Responsibilities:
- Execute analytical method validation, transfer, optimization, and lifecycle management for pharmaceutical raw materials, intermediates, and finished products.
- Support analytical investigations, including OOS results, deviations, root cause analysis, troubleshooting, and CAPA development.
- Serve as technical owner for analytical laboratory equipment (qualification, calibration, maintenance, lifecycle management, performance monitoring).
- Lead equipment qualification and implementation (qualification planning, CSV support, introduction of new analytical technologies, start-up/expansion readiness).
- Perform/support complex analytical testing using HPLC, UPLC, GC, LC-MS, ICP spectroscopy, dissolution, and physicochemical testing.
- Author/review/maintain analytical documentation (protocols, reports, specifications, SOPs, investigations, qualification documentation) per GxP.
- Support product transfers, validation programs, and implementation of new analytical methods/technologies.
- Ensure compliance with cGxP, data integrity, and regulatory/quality standards; support audits, inspections, commercial release testing, and continuous improvement.
Essential Requirements:
- Bachelor’s degree in Chemistry, Pharmacy, Microbiology, or related field; minimum 5 years in a cGMP lab supporting pharmaceutical/biotech operations.
- Hands-on experience with complex analytical techniques/instrumentation (HPLC, UPLC, GC, LC-MS, ICP spectroscopy, dissolution, and/or physicochemical testing).
- LabWare LIMS experience; familiarity building methods and using Empower CDS.
- Working knowledge of ICH Q2, Q7, Q10, GxP, data integrity principles, and good documentation practices.
- Ability to troubleshoot analytical methods/instrumentation while supporting compliant operations.
- Strong communication, collaboration, and problem-solving; ability to adapt to changing priorities and work cross-functionally.
- Execute analytical method validation, transfer, optimization, and lifecycle management for pharmaceutical raw materials, intermediates, and finished products.
- Support analytical investigations, including OOS results, deviations, root cause analysis, troubleshooting, and CAPA development.
- Serve as technical owner for analytical laboratory equipment (qualification, calibration, maintenance, lifecycle management, performance monitoring).
- Lead equipment qualification and implementation (qualification planning, CSV support, introduction of new analytical technologies, start-up/expansion readiness).
- Perform/support complex analytical testing using HPLC, UPLC, GC, LC-MS, ICP spectroscopy, dissolution, and physicochemical testing.
- Author/review/maintain analytical documentation (protocols, reports, specifications, SOPs, investigations, qualification documentation) per GxP.
- Support product transfers, validation programs, and implementation of new analytical methods/technologies.
- Ensure compliance with cGxP, data integrity, and regulatory/quality standards; support audits, inspections, commercial release testing, and continuous improvement.
Essential Requirements:
- Bachelor’s degree in Chemistry, Pharmacy, Microbiology, or related field; minimum 5 years in a cGMP lab supporting pharmaceutical/biotech operations.
- Hands-on experience with complex analytical techniques/instrumentation (HPLC, UPLC, GC, LC-MS, ICP spectroscopy, dissolution, and/or physicochemical testing).
- LabWare LIMS experience; familiarity building methods and using Empower CDS.
- Working knowledge of ICH Q2, Q7, Q10, GxP, data integrity principles, and good documentation practices.
- Ability to troubleshoot analytical methods/instrumentation while supporting compliant operations.
- Strong communication, collaboration, and problem-solving; ability to adapt to changing priorities and work cross-functionally.