Scientist/Senior Scientist/Principal Scientist-Biomarker
Frontage Laboratories
Summary
The Scientist/Senior Scientist/Principal Scientist will lead and support the development, qualification, validation, transfer, and implementation of biomarker assays for preclinical and clinical studies. The successful candidate will serve as a scientific leader responsible for project execution, client interactions, regulatory compliance, and scientific innovation. This position requires expertise in biomarker assay technologies and experience supporting regulated and non-regulated studies in a CRO, pharmaceutical, or biotechnology environment.
Job description
Position Summary
The Scientist/Senior Scientist/Principal Scientist will lead and support the development, qualification, validation, transfer, and implementation of biomarker assays for preclinical and clinical studies. The successful candidate will serve as a scientific leader responsible for project execution, client interactions, regulatory compliance, and scientific innovation. This position requires expertise in biomarker assay technologies and experience supporting regulated and non-regulated studies in a CRO, pharmaceutical, or biotechnology environment.
Scientific Leadership
- Design and lead biomarker assay development, optimization, qualification, validation, and sample analysis projects.
- Act as scientific lead for biomarker studies supporting drug discovery, translational research, and clinical development.
- Provide technical oversight and mentorship to research associates, scientists, and laboratory staff.
- Evaluate emerging technologies and implement innovative assay solutions to meet client needs.
- Identify and resolve technical and scientific challenges associated with biomarker measurements.
Assay Development & Validation
- Develop and validate biomarker assays for proteins, cytokines, chemokines, neurodegenerative markers, oncology biomarkers, immune biomarkers, and other translational endpoints.
- Design and execute fit-for-purpose, qualified, and fully validated biomarker methods according to applicable regulatory and industry guidance.
- Lead assay transfer activities from clients or partner laboratories.
- Establish assay performance characteristics.
Platform Expertise
Develop, troubleshoot, and validate single-plex and multiplex immunoassays using technologies including NULISA, SIMOA, MSD, Ella, Luminex, LC-MS/MS, and other emerging biomarker platforms as appropriate.
Project & Client Management
- Serve as primary scientific contact for assigned clients.
- Lead client meetings and technical discussions.
- Provide scientific updates, timelines, risk assessments, and project status reports.
- Collaborate with business development teams during proposal preparation and study planning.
- Support audits, inspections, and client visits.
Documentation & Regulatory Compliance
- Author, review, and approve study protocols, validation plans, analytical reports, technical reports, SOPs, deviations, CAPAs, change controls, and investigation reports.
- Ensure compliance with GLP, GCP (when applicable), FDA Bioanalytical Method Validation Guidance, EMA Bioanalytical Method Validation Guidance, and ICH guidance and industry best practices.
Business Development & Innovation (Senior Scientist / Principal Scientist)
- Support proposal generation, study design discussions, and technical consultations.
- Identify opportunities for new biomarker capabilities and service expansion.
- Contribute to publications, presentations, posters, and scientific conferences.
- Build strategic relationships with clients and industry partners.
- Drive implementation of new platforms and technologies.
Requirements
- M.S. in Biology, Biochemistry, Molecular Biology, or related discipline with 3+ years of relevant academia or industry experience; or Ph.D. in a related scientific discipline (Scientist)
- Ph.D. with 3+ years or M.S. with 6+ years of relevant academia or industry experience (Senior Scientist)
- Ph.D. with 8+ years of relevant academia or industry experience (Principal Scientist)
- Experience in biomarker assay development and validation
- Knowledge of immunoassay technologies and biomarker analysis
- Strong understanding of biomarker strategies across drug development stages
- Experience with regulated bioanalytical and translational biomarker studies
- Expertise in immunoassay development and validation principles
- Excellent problem-solving and scientific troubleshooting skills
- Strong project management capabilities
- Excellent oral and written communication skills
- Ability to work effectively in a fast-paced CRO environment managing multiple projects simultaneously
Benefits
- Health Insurance
- Dental Insurance
- 401(k) Plan
- Short-Term Disability Insurance
- Long-Term Disability Insurance
- Life Insurance
Company overview
Frontage Laboratories is a leading global Contract Research Organization (CRO) established in 2001 and headquartered in Exton, Pennsylvania. As an FDA-registered and inspected pharmaceutical development organization, Frontage provides comprehensive, science-driven services throughout the entire drug discovery and development lifecycle. The company operates 26 state-of-the-art facilities across North America, Europe, and Asia, serving biotechnology and pharmaceutical clients of all sizes. Frontage's integrated service portfolio includes drug discovery, drug metabolism and pharmacokinetics (DMPK), preclinical safety and toxicology, formulation development and manufacturing, analytical and bioanalytical testing, clinical trials, and central laboratory services. With over 1,800 employees worldwide, the company has established itself as a strategic partner in advancing innovative therapies from early discovery through regulatory submissions and commercialization. Frontage's expertise spans small molecules, biologics, cell and gene therapies, and agrochemicals, supported by GLP/GCP-compliant operations and a robust quality assurance framework that enables clients to navigate complex regulatory pathways in the US, EU, China, and other global markets.