Job Title: Bioanalytical Analyst
Job Summary:
* Role: Bioanalytical Analyst specializing in drug concentration measurement and sample testing.
* Technical Expertise: Advanced proficiency in LC-MS/MS and ELISA techniques.
* Regulatory Focus: Strict adherence to GLP, GCP, FDA, and ICH regulatory standards.
* Experience Level: 2 to 5+ years of relevant experience in a clinical or bioanalytical laboratory.
* Key Objective: Supporting drug discovery and clinical trials through accurate method development, validation, and data analysis.
Role Overview
We are currently seeking a dedicated and detail-oriented Bioanalytical Analyst to join our laboratory team. In this position, you will be responsible for the comprehensive testing of various biological matrices, including plasma, blood, and urine, to determine precise drug concentrations. You will work at the forefront of pharmaceutical development, applying high-level analytical techniques to support critical drug discovery initiatives and clinical trial processes. The ideal candidate is a professional who thrives in a highly regulated environment and is committed to maintaining the highest standards of scientific integrity and operational excellence.
Key Responsibilities
As a Bioanalytical Analyst, your daily contributions will be vital to the success of our research projects. Your core responsibilities will include:
Sample Processing: You will be responsible for the meticulous preparation of biological samples. This involves performing extraction processes using industry-standard techniques such as protein precipitation and solid-phase extraction to prepare matrices for analysis.
Instrumentation and Calibration: You will serve as a primary operator for sophisticated analytical instruments, including HPLC, LC-MS/MS, and ELISA systems. Your role includes routine calibration, performance verification, and proactive troubleshooting to ensure that all equipment operates within specified parameters.
Method Development and Validation: You will contribute to the design, execution, and validation of analytical methods. It is essential that these methods are developed to be both highly accurate and reproducible, ensuring that all data generated meets the rigorous demands of our clinical research programs.
Data Management and Reporting: Accuracy is paramount in this role. You will be responsible for documenting all experimental procedures, analyzing complex datasets, and preparing formal reports. All documentation must strictly align with the guidelines set forth by the FDA and the International Council for Harmonisation (ICH).
Regulatory Compliance: You will maintain a deep understanding of Good Laboratory Practice (GLP) and Good Clinical Practice (GCP) guidelines. Ensuring that all laboratory activities—from sample handling to data storage—strictly adhere to company Standard Operating Procedures (SOPs) and safety protocols is a fundamental aspect of this position.
Required Skills and Qualifications
To be considered for this position, candidates must possess a strong foundation in analytical chemistry and laboratory practices. We are looking for individuals who meet the following criteria:
Educational Background: A Bachelor of Science (B.Sc.) or Master of Science (M.Sc.) degree in Chemistry, Biochemistry, Life Sciences, or a related field. Candidates with a Bachelor of Pharmacy (B.Pharm.) or Master of Pharmacy (M.Pharm.) degree are also encouraged to apply.
Technical Proficiency: Proven hands-on experience with LC-MS/MS and HPLC instrumentation is essential. You should be comfortable working with bioanalytical assays and have a clear understanding of the underlying principles of chromatography and immunoassay techniques.
Regulatory Knowledge: A comprehensive understanding of the regulatory landscape is required. You should be familiar with the expectations and requirements established by the FDA and ICH for clinical and bioanalytical laboratories.
Professional Experience: We require a minimum of 2 to 5 years of professional experience working in a bioanalytical or clinical laboratory environment. Candidates should demonstrate a history of reliability, scientific accuracy, and the ability to work effectively within a fast-paced laboratory setting.
Why Join Our Team
Our laboratory environment is designed to foster professional growth and technical excellence. We provide our staff with the resources necessary to perform at the highest level while contributing to life-changing pharmaceutical research. If you are a driven professional with a passion for analytical chemistry and a commitment to quality, we invite you to apply and contribute to our ongoing success.
Application Process
We are looking for candidates who are ready to hit the ground running. Please ensure that your resume highlights your specific experience with instrumentation and your history of working within GLP/GCP-regulated environments. We look forward to reviewing your qualifications.