An analyst at a bioanalytical laboratory plays a crucial role in testing biological samples such as plasma, blood, and urine to measure drug concentrations. This position primarily utilizes LC-MS/MS or ELISA techniques, ensuring that method development, validation, and sample analysis are conducted under strict GLP/GCP regulatory standards to support drug discovery and clinical trials.
Key responsibilities include:
– Sample Processing: Extracting compounds from biological matrices using techniques like protein precipitation and solid-phase extraction.
– Instrumentation: Operating, calibrating, and troubleshooting instruments, including HPLC, LC-MS/MS, and ELISA.
– Method Development & Validation: Developing and validating methods to ensure the accuracy and reproducibility of assays.
– Data Management: Analyzing, documenting, and reporting experimental data accurately to meet regulatory requirements set by the FDA and ICH.
– Compliance: Adhering to SOPs, GLP/GCP guidelines, and maintaining safety standards.
Required skills and qualifications include:
– Education: A B.Sc. or M.Sc. in Chemistry, Biochemistry, Life Sciences, or a related field such as B.Pharm. or M.Pharm.
– Technical Skills: Hands-on experience with LC-MS/MS, HPLC, and bioanalytical techniques.
– Regulatory Knowledge: Familiarity with FDA and ICH guidelines.
– Experience: Typically requires 2–5+ years of experience in a bioanalytical laboratory or clinical laboratory.
