Bioanalytical Investigator & Method Lead

Resolian Inc.; Malvern (Chester County); On-site; USD 120,000 - 180,000; Full time

Job summary

Resolian in the US seeks an experienced Bioanalytical Principal Investigatory (BPI) Scientist I to provide scientific leadership across bioanalytical programs, including method development, validation, and regulatory submissions.

The role requires strong GLP/GCP experience, client interaction, and the ability to guide complex programs from preclinical to regulatory submission while ensuring high-quality data and compliance with FDA/EMA guidelines.

Qualifications

• Experience leading complex bioanalytical programs in regulated labs.
• Deep knowledge of GLP/GCP, 21 CFR Part 11, GDP and GMP requirements.
• Ability to independently perform complex lab work in a regulated setting.
• Strong documentation and data interpretation skills.
• Experience with ligand binding and biomarker assays is a plus.

Responsibilities

• Perform and lead complex bioanalytical work, validation, and method development with limited supervision.
• Serve as SME in bioanalytical assay development for biologics or biomarkers.
• Design and oversee bioanalytical strategies for preclinical to regulatory programs.
• Provide scientific oversight for troubleshooting data interpretation and studies.
• Ensure studies comply with GLP, GCP, and regulatory guidelines (FDA, EMA, ICH).
• Author, review, and approve protocols, validation reports, and study reports.

Skills

Bioanalytical leadership

GLP/GCP regulatory experience

Assay development & validation

Client & regulatory interaction

LIMS experience

Biomarkers & biologics assays

Education

Bachelor's degree or higher

Tools

LIMS

ELISA platforms

Job description

Resolian in the US seeks an experienced Bioanalytical Principal Investigatory (BPI) Scientist I to provide scientific leadership across bioanalytical programs, including method development, validation, and regulatory submissions.

The role requires strong GLP/GCP experience, client interaction, and the ability to guide complex programs from preclinical to regulatory submission while ensuring high-quality data and compliance with FDA/EMA guidelines.