AS&T Specialist

Key Responsibilities

• 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.

Essential Requirements

• 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 LabWare 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 cross-functional teams.

The salary for this position is expected to range between $89,600 and $166,400per year. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards. US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves.

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