Bioanalytical Principal Investigator- Scientist I Immunoassay

## Overview We are seeking an experienced Bioanalytical Principal Investigatory (BPI) **Scientist I** to provide scientific leadership within our bioanalytical contract research organization. This role is ideal for a scientist with deep technical expertise in bioanalysis, a strong understanding of regulated environments, and a proven ability to guide complex programs from method development through clinical and regulatory submission. The BPI will serve as a scientific authority, interact directly with clients, and contribute strategically to the growth of our bioanalytical capabilities. The successful candidate will: · Perform and lead complex lab work, sample analysis, validation, and method development with limited supervision · Serve as a subject matter expert in bioanalytical assay development, validation, and sample analysis for biologics, and/or biomarkers. · Design and oversee complex bioanalytical strategies supporting preclinical, clinical, and regulatory programs. · Provide scientific oversight for troubleshooting methods, data interpretation, and investigative studies. · Ensure studies are conducted in compliance with GLP, GCP, and regulatory guidelines (FDA, EMA, ICH). Author, review, and approve bioanalytical protocols, validation reports, and study reports. ## Description · Develop, validate, and troubleshoot bioanalytical methods for sample testing and data reporting, serving as the BPI as required. · Present and interpret data both internally and externally, ensuring clarity and scientific rigor. · Maintain client satisfaction through timely communication, responsiveness, and on-schedule delivery of high-quality results. · Prepare and review laboratory data and controlled documents, including study plans and final reports. · Support laboratory operations and provide mentorship to junior staff members. · Contribute to the development and refinement of policies, procedures, work instructions, and standard operating procedures (SOPs). · Ensure compliance with company standards, including Code of Conduct, Environmental Health and Safety (EHS), and GLP/GCP/GDP regulations. · Perform additional duties as assigned to support team and organizational goals. ## Requirements · BA/BS or higher with 7-8 years lab experience; all experiences will be evaluated · Knowledge and understanding of regulatory requirements; GLP, GCP, 21CFR Part 11, GDP, GMP and demonstrated experience working in GLP/GCP regulated laboratories. · Ability to independently perform complex lab work · Ability to work in a regulated environment · Ability to work effectively and contribute within a team · Ability to work with computer systems · Ability to document clearly · Knowledge of and experience in a regulatory environment · Experience with ligand binding assays (ELISA, MSD, Gyros) · Experience with biomarker and/or immunogenicity assays · Experience with LIMS · Proven ability to lead complex scientific programs and interact directly with clients and regulators.