Senior Analytical Chemist

Senior Analytical Chemist

We are seeking a hands-on Senior Analytical Chemist / Quality Control Manager to lead laboratory operations while actively performing analytical testing in a GMP-regulated manufacturing environment. This unique role combines bench-level analytical chemistry responsibilities with quality control leadership, making it ideal for a technical expert who enjoys both laboratory work and team management.

Key Responsibilities

• Perform analytical testing of raw materials, in-process samples, finished products, and stability samples using HPLC, GC, GC-MS, FTIR, UV-Vis, and wet chemistry techniques.
• Develop, validate, transfer, and troubleshoot analytical methods for new and existing products.
• Manage day-to-day QC laboratory operations, including analytical and microbiological testing programs.
• Oversee investigations, deviations, CAPAs, change controls, specifications, and quality metrics.
• Lead and mentor laboratory personnel, providing training, coaching, and performance management.
• Manage the site stability program and ensure compliance with GMP, GLP, FDA, USP, and other applicable regulations.
• Support audit readiness activities and drive continuous improvement initiatives across laboratory operations.
• Review and approve laboratory documentation, validation protocols, SOPs, investigations, and technical reports.
• Partner cross-functionally with Quality, Manufacturing, and R&D to support product quality and business objectives.

Qualifications

• Bachelor's degree in Chemistry required;
  Master's degree preferred.
• Minimum 5 years of hands-on analytical chemistry experience in a GMP-regulated environment.
• Strong experience with HPLC, GC, GC-MS, FTIR, UV-Vis, and wet chemistry techniques.
• Experience with method development, validation, transfer, and troubleshooting.
• Previous supervisory or management experience within a QC laboratory.
• Strong understanding of FDA, GMP, GLP, USP, ICH, and quality system requirements.
• Experience with LIMS and laboratory data management systems preferred.

Ideal Background

Candidates may come from pharmaceutical, biologics, food, nutraceutical, or other regulated manufacturing environments and should possess a strong blend of technical laboratory expertise, quality systems knowledge, and leadership capabilities.

What We're Looking For

A hands-on leader who enjoys solving technical challenges, developing people, improving laboratory processes, and ensuring the highest standards of quality and compliance.