Principal Scientist-Biomarker

Frontage Laboratories•Hayward, CA

3d•Onsite

About The Position

Frontage Laboratories Inc. is seeking a Scientist, Senior Scientist, or Principal Scientist for its Biomarker Services group in Hayward, California. The group supports pharmaceutical, biotechnology, and academic clients with biomarker assay development, validation, and sample analysis across therapeutic areas including oncology, neuroscience, immunology, inflammation, metabolic diseases, and rare diseases. It uses technologies such as NULISA™, SIMOA®, MSD®, Luminex®, Ella™, ELISA, and LC-MS/MS. The successful candidate will lead and support the development, qualification, validation, transfer, and implementation of biomarker assays for preclinical and clinical studies. The role provides scientific leadership for project execution, client interactions, regulatory compliance, and scientific innovation. The individual will collaborate with clients, project management, quality assurance, and laboratory personnel to deliver high-quality biomarker data on established timelines. The appropriate level depends on the candidate’s education and experience; senior and principal-level responsibilities include additional client leadership, business development, strategic growth, and technology implementation.

Requirements

Scientist: M.S. in Biology, Biochemistry, Molecular Biology, or a related discipline with 3 or more years of relevant academic or industry experience, or a Ph.D. in a related scientific discipline.
Senior Scientist: Ph.D. with 3 or more years, or M.S. with 6 or more years, of relevant academic or industry experience.
Principal Scientist: Ph.D. with 8 or more years of relevant academic or industry experience.
Experience in biomarker assay development and validation.
Knowledge of immunoassay technologies and biomarker analysis.
Senior Scientist: demonstrated experience leading biomarker assay development and validation programs and independently managing client-facing projects.
Principal Scientist: recognized technical expertise in biomarker assay development and validation; proven record leading complex biomarker programs and client relationships; and experience supporting business development, strategic growth initiatives, and technology implementation.
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, 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.

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 innovative assay solutions to meet client needs.
Identify and resolve technical and scientific challenges associated with 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 client meetings and technical discussions.
Provide scientific updates, timelines, risk assessments, and project status reports.
Collaborate with business development teams on proposals and study planning.
Support audits, inspections, and client visits.
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 and EMA Bioanalytical Method Validation Guidance, ICH guidance, and industry best practices.
At Senior Scientist or Principal Scientist level, support proposal generation, study design discussions, and technical consultations.
At Senior Scientist or Principal Scientist level, 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.
At Senior Scientist or Principal Scientist level, drive implementation of new platforms and technologies.