Principal Scientist-Biomarker

Frontage Laboratories•Hayward, CA

16h•$80,000 - $150,000•Onsite

About The Position

Frontage Laboratories Inc. is hiring at the Scientist, Senior Scientist, or Principal Scientist level for its Biomarker Services group in Hayward, California. The group provides biomarker assay development, validation, and sample-analysis services to pharmaceutical, biotechnology, and academic clients in therapeutic areas including oncology, neuroscience, immunology, inflammation, metabolic diseases, and rare diseases. The role leads and supports development, qualification, validation, transfer, and implementation of biomarker assays for preclinical and clinical studies. The successful candidate provides scientific leadership for project execution, client interactions, regulatory compliance, and scientific innovation, working with clients, project management, quality assurance, and laboratory personnel to deliver high-quality data on established timelines. Assay platforms include NULISA, SIMOA, MSD, Ella, Luminex, ELISA, and LC-MS/MS. Responsibilities and seniority-specific scope include scientific oversight and mentorship, client-facing project management, preparation and review of technical and regulatory documentation, support for audits and inspections, and—at Senior Scientist and Principal Scientist levels—business development, service expansion, scientific communications, and implementation of new technologies.

Requirements

For Scientist: M.S. in Biology, Biochemistry, Molecular Biology, or a related discipline with 3+ years of relevant academic or industry experience, or a Ph.D. in a related scientific discipline.
For Scientist: experience in biomarker assay development and validation, and knowledge of immunoassay technologies and biomarker analysis.
For Senior Scientist: Ph.D. with 3+ years or M.S. with 6+ years of relevant academic or industry experience.
For Senior Scientist: demonstrated experience leading biomarker assay development and validation programs, independently managing client-facing projects, and strong scientific troubleshooting and leadership skills.
For Principal Scientist: Ph.D. with 8+ years of relevant academic or industry experience.
For Principal Scientist: recognized technical expertise in biomarker assay development and validation; a track record leading complex biomarker programs and client relationships; experience supporting business development, strategic growth, and technology implementation; and leadership in scientific publications, presentations, or industry contributions.
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 while managing multiple projects simultaneously.

Nice To Haves

Experience with ultra-sensitive biomarker platforms such as NULISA and SIMOA.
Experience with neurodegenerative, oncology, inflammatory, or 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.

Responsibilities

Design and lead biomarker assay development, optimization, qualification, validation, and sample-analysis projects.
Serve 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 assay solutions to meet client needs.
Identify and resolve technical and scientific challenges related to biomarker measurements.
Develop and validate 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 transfers from clients or partner laboratories and establish assay performance characteristics.
Develop, troubleshoot, and validate single-plex and multiplex immunoassays using relevant biomarker platforms.
Serve as the primary scientific contact for assigned clients; lead meetings and technical discussions; and provide updates, timelines, risk assessments, and status reports.
Collaborate with business development on proposals and study planning.
Support audits, inspections, and client visits.
Author, review, and approve study protocols, validation plans, analytical and technical reports, SOPs, deviations, CAPAs, change controls, and investigation reports.
Ensure compliance with applicable GLP, GCP, FDA and EMA bioanalytical method validation guidance, ICH guidance, and industry best practices.
At Senior Scientist and Principal Scientist levels, support proposals, study design discussions, and technical consultations; identify opportunities for new biomarker capabilities and service expansion; contribute to publications and scientific presentations; build client and industry relationships; and drive implementation of new platforms and technologies.