Quality Control Method Development Specialist

The Quality Control Method Development Specialist is responsible for providing technical leadership for analytical method development, optimization, validation, verification, and transfer activities in support of ISO/IEC 17025 accreditation requirements, cGMP compliance, and laboratory quality system objectives. This position serves as the laboratory subject matter expert for analytical methodologies and instrumentation, including HPLC, GC, ICP-MS, HPTLC, UV/Vis, Protein Analyzer, and other laboratory technologies.

The Method Development Specialist supports implementation of new analytical technologies, leads technical aspects of laboratory investigations, develops and executes validation protocols, and collaborates with Quality Control Operations, Product Development, Quality Assurance, and other stakeholders to ensure analytical methods are scientifically sound, compliant, and fit for intended use.

This role is a key member of the Quality Control Compliance Team and plays a critical role in maintaining accreditation, reducing validation backlogs, improving data quality, and supporting continuous improvement initiatives.

Requirements

MINIMUM JOB QUALIFICATIONS AND REQUIREMENTS

• Bachelor’s degree in chemistry, Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, or another natural or physical science.

• 3+ years of experience in analytical method developmen