AS&T Specialist

Role: AS&T Specialist supporting start-up and growth of Novartis' Small Molecules Quality Control lab in Morrisville, focused on analytical method validation, transfer, troubleshooting, and equipment qualification. Responsibilities: execute complex analytical testing (HPLC, UPLC, LC-MS, GC, ICP spectroscopy), lead equipment qualification and technology implementation, support product transfers and validation, author and review GxP-compliant documentation, and ensure data integrity and regulatory compliance. Requirements: Bachelor's in Chemistry, Pharmacy, Microbiology or related field; 5+ years in a cGMP pharmaceutical or biotech lab; hands-on experience with advanced analytical techniques and instrumentation; familiarity with LabWare LIMS, Empower CDS, and ICH GxP standards; strong troubleshooting, documentation, and cross-functional collaboration skills. High-Value: support small molecule manufacturing, analytical method lifecycle management, equipment qualification, and implementation in a GMP setting; focus on quality control for raw materials, intermediates, and finished products. WorkSetup: Morrisville, NC, with potential for future lab expansion activities.