AS&T Specialist

About the role

The AS&T Specialist supports the start-up and growth of Novartis' Small Molecules Quality Control laboratory in Morrisville, North Carolina. The role provides scientific analytical support across method validation, method transfer, analytical troubleshooting, equipment qualification and commercial testing, ensuring quality, compliance and data integrity. It is an on-site position.

Key responsibilities

• Execute analytical method validation, transfer, optimization and lifecycle management for raw materials, intermediates and finished products.
• Support analytical investigations, including OOS results, deviations, root cause analysis, troubleshooting and CAPA development.
• Act as technical owner of analytical laboratory equipment, coordinating qualification, calibration, maintenance and performance monitoring.
• Lead equipment qualification and implementation, including CSV support, introduction of new analytical technologies and laboratory start-up and expansion readiness.
• Perform and support complex testing with HPLC, UPLC, GC, LC-MS, ICP spectroscopy, dissolution and physicochemical testing.
• Author, review and maintain protocols, reports, specifications, SOPs, investigations and qualification documentation under GxP.
• Support product transfers, validation programs and new analytical methods, and ensure compliance with cGxP, data integrity and regulatory standards during audits, inspections and commercial release testing.

Required profile

• Bachelor's degree in Chemistry, Pharmacy, Microbiology or a related scientific discipline.
• At least 5 years of experience in a cGMP laboratory supporting pharmaceutical or biotechnology operations.
• Hands-on experience with complex analytical techniques and instrumentation.
• Experience with LabWare LIMS and familiarity with building methods and using Empower CDS.
• Knowledge of ICH Q2, Q7, Q10, GxP, data integrity and good documentation practices.
• Strong communication, collaboration and problem-solving skills.

Required skills

• HPLC, UPLC, GC, LC-MS, ICP spectroscopy, dissolution and physicochemical testing
• Method validation and validation activities
• Data integrity and GLP/GxP compliance

What we offer

• Expected salary of $89,600 to $166,400 per year, depending on skills and experience.
• Performance-based cash incentive and possible eligibility for annual equity awards.
• Health, life and disability benefits, 401(k) with company contribution and match.
• Vacation, personal days, holidays and other leaves.