Bioanalytical Principal Investigator

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.

Responsibilities

• 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.

Skills, Education \& Qualifications

· 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.