Bioanalytical Principal Investigator- Scientist I Immunoassay

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.BA/BS or higher with 7-8 years lab experience; all experiences will be evaluatedKnowledge 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 workAbility to work in a regulated environmentAbility to work effectively and contribute within a teamAbility to work with computer systemsAbility to document clearlyKnowledge of and experience in a regulatory environmentExperience with ligand binding assays (ELISA, MSD, Gyros)Experience with biomarker and/or immunogenicity assaysExperience with LIMSProven ability to lead complex scientific programs and interact directly with clients and regulators.