Senior QC Analytical Scientist - Method Validation & Lead

Promega; Kentucky; On-site; USD 85,000 - 120,000; Full time

Job summary

Promega in the United States, Kentucky, seeks a QC Analytical Scientist 3 to perform complex analytical testing for API release and stability. You will lead method validation, assist in new method development, and train team members in instrumentation and proper documentation.

You will mentor junior scientists, troubleshoot lab equipment, and ensure QA compliance across processes while supporting continuous improvement and digital tool adoption. Some off-hours work may be required.

Qualifications

• BS in Chemistry or related field with 3+ years QC experience, or MS with 2+ years QC experience.
• Demonstrated record of independent method validation and characterization.
• Strong knowledge of analytical instrumentation (HPLC, LC-MS, GC, NMR, ICP-MS, Karl Fisher, XR-PD, FTIR, spectrophotometers).
• Proficiency with statistical analysis tools (mean, SD, regression, confidence intervals).
• Experience in mentoring or training staff.
• Proficiency in digital tools and technology, including Microsoft apps and AI-enabled workflows.

Responsibilities

• Perform analytical method validation and characterization independently to support process improvement, product transfer, or new product realization projects.
• Lead investigations of Out of Specification (OOS) results and nonconformances, identifying root causes and corrective actions.
• Draft, review, and revise QC procedures, including SOPs, protocols, and inspection plans, ensuring compliance with documentation policy.
• Act as lead analyst for complex QC testing of raw materials, intermediates, and final products.
• Mentor and train QC Analytical Scientist 1 and 2 staff in laboratory methods, instrumentation, and good documentation practices.
• Maintain and troubleshoot QC Lab instrumentation and associated analytical methods utilized for product release testing. Perform method evaluation/re-validation as needed.
• Evaluate and interpret complex analytical testing results and ensure accurate reporting.
• Report results of release testing per Quality System requirements and issue COAs as needed.
• Contribute to retention, reference standard, and stability program management.
• Champion the use of AI and digital tools to enhance team efficiency and operational quality.
• May require occasional work outside standard hours to meet organizational needs.
• Embrace Promega’s ESI principles; act with kindness, curiosity, and respect for others.
• Understand and comply with ethical, legal and regulatory requirements applicable to our business.

Skills

Mentoring staff

Digital tools & AI adoption

Statistical analysis

Method validation leadership

Cross-functional collaboration

Education

BS in Chemistry or related field

MS in Chemistry or related field

Tools

HPLC

LC-MS

GC

NMR

ICP-MS

Karl Fischer

XR-PD

FTIR

Spectrophotometers

Job description

Promega in the United States, Kentucky, seeks a QC Analytical Scientist 3 to perform complex analytical testing for API release and stability. You will lead method validation, assist in new method development, and train team members in instrumentation and proper documentation.

You will mentor junior scientists, troubleshoot lab equipment, and ensure QA compliance across processes while supporting continuous improvement and digital tool adoption. Some off-hours work may be required.