AS&T Specialist

U473 (FCRS = US473) Novartis Gene Therapies; Morrisville (NC); On-site; USD 90,000 - 166,000; Full time

Job summary

Novartis Gene Therapies in Morrisville, North Carolina, is hiring an AS&T Specialist to support start-up and growth of the small molecules QC lab. You will drive method validation, transfers and troubleshooting, while coordinating equipment qualification and technology implementation.

The role involves data integrity, cGxP compliance, and collaboration with cross-functional teams to enable product transfers and manufacturing readiness at the Morrisville site.

Qualifications

• Bachelor's degree in Chemistry, Pharmacy, Microbiology or related scientific discipline; minimum 5 years in a cGMP lab supporting pharma/biotech operations.
• Hands-on with HPLC, UPLC, GC, LC-MS, ICP spectroscopy, dissolution, and physicochemical testing.

Responsibilities

• Execute method validation, transfer, optimization, and lifecycle management for pharmaceutical materials.
• Provide scientific support for investigations, OOS, deviations, root cause analysis, troubleshooting, and CAPA development.
• Serve as technical owner for analytical equipment; coordinate qualification, calibration, maintenance, and monitoring.

Skills

Collaboration

Communication

Data Integrity

Decision Making

Good Laboratory Practices (GLPs)

Laboratory Standards

Laboratory Testing

Managing Ambiguity

Method Validation

Process Validation

Quality Compliance

Quality Control (QC)

Quality Management Systems (QMS)

Regulatory Compliance

Standard Operating Procedure (SOP)

Statistical Process Control (SPC)

Validation Activities

Education

Bachelor's degree in Chemistry, Pharmacy, Microbiology

Tools

LabWare LIMS

Empower CDS

Job description

Job Description Summary #LI-Onsite 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.

Job Description 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 $166,400 per 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.

Skills Desired

• Collaboration
• Communication
• Data Integrity
• Decision Making
• Good Laboratory Practices (GLPs)
• Laboratory Standards
• Laboratory Testing
• Managing Ambiguity
• Method Validation
• Process Validation
• Quality Compliance
• Quality Control (QC)
• Quality Management Systems (QMS)
• Regulatory Compliance
• Standard Operating Procedure (SOP)
• Statistical Process Control (SPC)
• Validation Activities

Improving the lives of people living with disease takes more than innovative science. It takes a focus on the needs of people and a community committed to meeting them. It takes a team of people like you. Working together. Learning together. Thriving together. Discover how you can join us in changing people’s lives.

EEO Statement

The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.

Accessibility and reasonable accommodations

The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to [e-mail] or call [phone] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Salary Range $89,600.00 - $166,400.00

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