Analytical Chemistry Specialist

About the role

This position plays an important role in BioSpectra’s Laboratory Services department. The Analytical Chemistry Specialist is responsible for all stages of method implementation—from method development and validation to routine analysis—and for instrumentation development work, including bringing new instrumentation online and streamlining existing methods. This role is ideal for an analytical chemistry professional seeking a challenging opportunity with a growing bio-pharmaceutical company.

Responsibilities

• Operate complex laboratory instrumentation, including HPLC, UPLC, ICP-MS, ICP-OES, GC-MS, GC-FID, IC, and SEM.
• Maintain and troubleshoot issues related to complex instrumentation.
• Maintain inventory and storage of instrumentation equipment and accessories.
• Assist in method development for new products and streamline methods for existing products.
• Assist in method validation protocol generation, execution, peer review, and data analysis.
• Generate reports regarding instrumentation.
• Assist in out-of-specification (OOS) result investigations by processing/interpreting data, conducting analysis, and evaluating instrumentation.
• Function as an analytical subject matter expert for instrument analytical methods.
• Train QC Analysts to perform analysis on complex instrumentation.
• Perform organic impurity analysis to support regulatory submissions.
• Source and qualify reference standards for analysis when applicable.
• Perform and review routine instrument testing and analysis.

Requirements

• Bachelor's degree in Science or related field, and/or commensurate experience.
• Minimum of one to three years of experience in a quality control and/or cGMP laboratory.
• Demonstrated knowledge and experience operating LC, ICP, and GC instrumentation in a GMP laboratory.
• Experience in the pharmaceutical or related industry in a laboratory setting, with knowledge of cGMP and related compliance regulations.

Skills

• Perform data analysis, complex analytical calculations, and statistical analysis.
• Train QA Analysts on instrument analysis.
• Write analytical protocols and reports.
• Perform organic impurity analysis.