Principal Investigator- Scientist, Immunoassay

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 – Your global bioanalytical, biomarker and analytical sciences partner supporting all phases of your drug development.

Resolian is a leading global Contract Research Organization (CRO) providing specialized services in GxP and non-regulated bioanalysis, drug metabolism/pharmacokinetic (DMPK), and GMP CMC analytical and materials science. Its team of more than 400 experts across the US, UK, and Australia, Resolian supports pharma and biotech companies’ programs throughout the entire drug development continuum.

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.

Description

• 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.