<p>Responsibilities</p> <ul> <li> <p>Develop, validate, and troubleshoot bioanalytical methods for sample testing and data reporting, serving as the Principal Investigator (PI) as required.</p> </li><li> <p>Present and interpret data both internally and externally, ensuring clarity and scientific rigor.</p> </li><li> <p>Maintain client satisfaction through timely communication, responsiveness, and on-schedule delivery of high-quality results.</p> </li><li> <p>Prepare and review laboratory data and controlled documents, including study plans and final reports.</p> </li><li> <p>Support laboratory operations and provide mentorship to junior staff members.</p> </li><li> <p>Contribute to the development and refinement of policies, procedures, work instructions, and standard operating procedures (SOPs).</p> </li><li> <p>Ensure compliance with company standards, including Code of Conduct, Environmental Health and Safety (EHS), and GLP/GCP/GDP regulations.</p> </li><li> <p>Perform additional duties as assigned to support team and organizational goals.</p> </li><li></li></ul> <p>Skills, Education & Qualifications</p> <ul> <li> <p>BA/BS or higher with 7-8 years lab experience; all experiences will be evaluated</p> </li><li> <p>Knowledge and understanding of regulatory requirements; GLP, GCP, 21CFR Part 11, GDP, GMP</p> </li><li> <p>Able to independently perform complex lab work</p> </li><li> <p>Able to work in a regulated environment</p> </li><li> <p>Able to work effectively and contribute within a team</p> </li><li> <p>Able to work with computer systems</p> </li><li> <p>Able to document clearly</p> </li><li> <p>Knowledge of and experience in a regulatory environment</p> </li></ul>