Scientist/Senior Scientist/Principal Scientist-Biomarker

Frontage Laboratories, Inc.; Hayward (CA); On-site; USD 80,000 - 150,000; Full time

Benefits offered by this job

Health insurance

401(k) plan

Disability insurance

Job summary

Frontage Laboratories, Inc. in Hayward, CA seeks a Scientist, Senior Scientist or Principal Scientist to lead and support biomarker assay development, validation and transfer for preclinical and clinical studies.

The role requires expertise in immunoassay technologies, regulated bioanalytical studies, and strong project leadership to collaborate with clients, QA, and lab staff while delivering high-quality biomarker data on time.

Qualifications

• MS/PhD with 3+ years biomarker assay development and validation
• Knowledge of immunoassay technologies and biomarker analysis
• Experience in regulated CRO/pharma environments

Responsibilities

• Design and lead biomarker assay development, optimization, qualification and validation
• Lead biomarker studies for drug discovery, translational research, and clinical development
• Provide mentorship to staff and coordinate with clients, QA, and lab personnel
• Evaluate new technologies and implement innovative assay solutions
• Ensure timely and compliant data delivery with regulatory guidance

Skills

Biomarker assay development

Immunoassay development

Regulatory compliance

Project management

Scientific leadership

NULISA

SIMOA

Luminex

MSD

ELISA

Education

MS in Biology/Biochemistry/Molecular Biology or related

PhD in related discipline

Tools

NULISA

SIMOA

MSD

Ella

Luminex

LC-MS/MS

Job description

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

Hayward, CA, US

Salary Range: $80,000.00 To $150,000.00 Annually

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 and Requirements

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.