Analytical QC Specialist: Method Validation & Transfer

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

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.