- 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.
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.