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 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.