Scientist/Senior Scientist/Principal Scientist-Biomarker

Title: Scientist / Senior Scientist / Principal Scientist – Biomarker Services Location: Hayward, CA Reports To: Manager/Supervisor Biomarker Company Frontage Laboratories Inc. is an award winning, publicly listed, full-service CRO/Contract Research Organization operating over 25 state-of-the-art laboratories across the US, Canada, and China, growing significant YoY growth.

Our core competencies include pre-clinical, drug metabolism, pharmacokinetics/ pharmacodynamics (PK/PD), safety and toxicology, bioanalytical services, chemistry and manufacturing controls for drug development, and core laboratory services for clinical trials. Biomarker Services Frontage's Biomarker Services group provides comprehensive biomarker assay development, validation, and sample analysis support for pharmaceutical, biotechnology, and academic clients across a broad range of therapeutic areas, including oncology, neuroscience, immunology, inflammation, metabolic diseases, and rare diseases.

Our scientists have employed state-of-the-art technologies including NULISA™, SIMOA®, MSD®, Luminex®, Ella™, ELISA, LC-MS/MS, and other emerging ultra-sensitive detection platforms to deliver high-quality biomarker data that enable critical drug development decisions.

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. The individual will work closely with clients, project management, quality assurance, and laboratory personnel to ensure the successful delivery of high-quality biomarker data within established timelines.

Roles and Responsibilities: 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.

Education

Scientist 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. Experience in biomarker assay development and validation. Knowledge of immunoassay technologies and biomarker analysis. Senior Scientist Ph.

D. with 3+ years or M.S. with 6+ years of relevant academia or industry experience. Demonstrated experience leading biomarker assay development and validation programs. Experience independently managing client-facing projects. Strong scientific troubleshooting and leadership skills. Principal Scientist Ph.D. with 8+ years of relevant academia or industry experience.

Recognized technical expert in biomarker assay development and validation. Proven track record leading complex biomarker programs and client relationships. Experience supporting business development, strategic growth initiatives, and technology implementation. Demonstrated leadership in scientific publications, presentations, or industry contributions.

Required Skills

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.

Preferred Qualifications

Experience with ultra-sensitive biomarker platforms such as NULISA and SIMOA. Experience with neurodegenerative biomarkers, oncology biomarkers, inflammatory and immune biomarkers. Familiarity with large molecule PK, pharmacodynamic, ADA, and NAb assays. Experience supporting preclinical and clinical biomarker studies.

Experience in GLP-regulated CRO environments. Publication history or scientific conference presentations preferred. Salary and Benefits: Frontage Laboratories offers a competitive compensation and generous benefits package including health and dental insurance, a 401(k) plan, health insurance, short and long-term disability insurance, life insurance etc.

Salary Range: $80,000 to $150,000 Frontage Laboratories Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with disability.