Analytical Method Validation & Stability Leader

Guerbet; Raleigh (NC); On-site; USD 100,000 - 150,000; Full time

Job summary

Guerbet, a global leader in medical imaging, seeks a QC LCM/Stability Lead in Raleigh, NC to supervise analytical method validation and stability programs within a cGMP framework.

You will act as SME during regulatory inspections, guide lifecycle management of methods, and ensure data integrity while driving cross-functional collaboration across QA, Regulatory Affairs, and Manufacturing.

Qualifications

• Bachelor’s degree in Chemistry or related field; 10+ years experience, or Master’s with 5+ years, or PhD with 2+ years.
• Extensive analytical method validation experience in a cGMP-pharma environment.
• Strong knowledge of regulatory expectations (cGMP, ICH Q2, Q1A, USP).
• Experience with analytical techniques (HPLC, GC, dissolution, spectroscopy).
• Familiarity with laboratory systems (LIMS, Empower, CDS) and data integrity (ALCOA+).
• Excellent written and verbal communication; ability to work cross-functionally.

Responsibilities

• Lead the analytical method validation strategy across products with regulatory alignment.
• Serve as SME during FDA/EMA inspections and audits, including defense of methodologies.
• Provide technical leadership, coaching, and mentorship to junior staff.
• Review and approve validation protocols, reports, and documentation.
• Design and oversee validation/verification protocols (accuracy, precision, specificity, linearity, range, robustness).
• Interpret validation data ensuring ALCOA+ data integrity.
• Set standards for deviations, OOS, OOT, and atypical results and escalation.
• Lead investigations into method-related quality issues and CAPA implementations.
• Own lifecycle management of analytical methods including transfers and changes.
• Ensure laboratory systems and processes are compliant, qualified, calibrated, and audit-ready.
• Drive cGMP compliance and regulatory readiness with global expectations.

Skills

Problem solving

Cross-functional collaboration

Communication skills

Analytical thinking

Education

Bachelor’s degree in Chemistry or related field

Master’s degree in Chemistry or related field

PhD in Chemistry or related field

Tools

HPLC

GC

Dissolution

Spectroscopy

LIMS

Empower

CDS

Job description

Guerbet, a global leader in medical imaging, seeks a QC LCM/Stability Lead in Raleigh, NC to supervise analytical method validation and stability programs within a cGMP framework.

You will act as SME during regulatory inspections, guide lifecycle management of methods, and ensure data integrity while driving cross-functional collaboration across QA, Regulatory Affairs, and Manufacturing.