QC Lab Startup: Analytical Science Specialist

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

Benefits offered by this job

Health benefits

401(k) with company match

Generous time off

Job summary

Novartis Innovative Technologies Inc in Morrisville, North Carolina is building a new Small Molecules QC laboratory. The AS&T Specialist will support method validation, transfers, troubleshooting, equipment qualification, and QC testing across HPLC/UPLC, GC, LC-MS, ICP, and dissolution.

You’ll own qualification activities, CSV support, and lifecycle management while working with cross-functional teams to enable smooth product transfers and site readiness.

Qualifications

• Bachelor's degree in Chemistry, Pharmacy, Microbiology, or related scientific discipline with minimum 5 years in a cGMP lab.
• Hands-on experience with analytical techniques (HPLC, UPLC, GC, LC-MS, ICP) and dissolution/physicochemical testing.
• Experience using LabWare LIMS and Empower CDS; familiarity with ICH Q2, Q7, Q10 and data integrity principles.

Responsibilities

• Execute analytical method validation, transfer, optimization, and lifecycle management for materials and finished products.
• Provide technical support for investigations (OOS, deviations, CAPA).
• Own analytical laboratory equipment lifecycle management, qualification, calibration and maintenance.
• Lead equipment qualification, CSV support, and integration of new technologies for start-up/expansion.
• Perform complex testing using HPLC, UPLC, GC, LC-MS, ICP, dissolution.
• Prepare and maintain GMP documentation (protocols, reports, specs, SOPs, investigations).
• Support product transfers and validation programs for new methods and technologies.
• Ensure cGxP compliance, data integrity, and support audits and continuous improvement.

Skills

Collaboration

Communication

Data Integrity

Decision Making

GLPs

Laboratory Standards

Laboratory Testing

Managing Ambiguity

Method Validation

Process Validation

Quality Compliance

Quality Control (QC)

Quality Management Systems (QMS)

Regulatory Compliance

SOP

SPC

Validation Activities

Education

Bachelor's degree in Chemistry, Pharmacy, Microbiology, or related

Tools

LabWare LIMS

Empower CDS

Job description

Novartis Innovative Technologies Inc in Morrisville, North Carolina is building a new Small Molecules QC laboratory. The AS&T Specialist will support method validation, transfers, troubleshooting, equipment qualification, and QC testing across HPLC/UPLC, GC, LC-MS, ICP, and dissolution.

You’ll own qualification activities, CSV support, and lifecycle management while working with cross-functional teams to enable smooth product transfers and site readiness.