Sr Scientist - Biomarker Development

Kelly; Charlotte (NC); Remote; USD 130,000 - 170,000; Full time

Job summary

Kelly Science & Clinical seeks a Senior Scientist – Biomarker Development to lead biomarker assay design and qualification from research to early clinical development for a client in San Diego, CA. The role involves managing CRO partnerships, coordinating sample logistics, and contributing to regulatory artifacts.

The candidate should have MS with 6+ years or PhD with 3+ years in biomarker or molecular biology, with hands-on ELISA and MSD experience and strong scientific writing abilities.

Qualifications

• MS with 6+ years or PhD with 3+ years in a lab setting.
• Hands-on experience developing and qualifying ligand-binding assays incl. ELISA/MSD.
• Experience overseeing in vitro/in vivo assay design for gene therapy, small molecules, or proteins.
• Experience taking assays from development to qualification for clinical testing.
• Direct or CRO management of sample testing procedures.
• Experience contributing biomarker content to regulatory submissions preferred.
• Proven documentation in ELN or lab notebooks and strong scientific writing.

Responsibilities

• Design, develop, and qualify biomarker assays for proteins and pharmacodynamic markers.
• Oversee clinical biomarker testing at CRO partners and manage sample logistics.
• Define sample collection, processing, and storage requirements.
• Provide biomarker input to program decisions and regulatory documents.
• Maintain detailed experimental records and SOPs.
• Evaluate new biomarker technologies to address development questions.

Skills

Molecular biology experience

ELISA

MSD electrochemiluminescence

CRO management

In vitro/in vivo assay design

Regulatory submissions awareness

Scientific writing

Problem solving

Education

MS degree

PhD degree

Tools

ELISA platforms

MSD platforms

Job description

Senior Scientist – Biomarker Development

Kelly Science & Clinical is seeking a Senior Scientist – Biomarker Development for a contract-to-hire position at a cutting-edge client in San Diego, CA. If you’re passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts.

Pay: $130-170k
Schedule: Remote M-F

Overview

Our Client is an industry-leading, clinical-stage biotherapeutics company that’s leading the way in developing breakthrough neuroprotective therapeutics for highly prevalent, blinding diseases that currently have no good therapeutic alternatives. Using novel approaches, our Client is advancing first-in-class and best-in-class protein therapeutics and gene therapy solutions poised to significantly impact patients’ lives.

In this role, you will join a growing team as a Senior Scientist focused on biomarker development and testing, spanning research through early clinical development. You will help define fit-for-purpose biomarker plans for both gene therapy and small molecule therapeutic candidates, develop and qualify the assays that support those plans, and oversee execution of clinical testing through internal and external laboratories — including evaluating how a given drug impacts its target biomarker across both small molecule and biologic programs.

Responsibilities

• Design, develop, and optimize molecular and protein-based assays for quantitation of therapeutic proteins, target engagement markers, and pharmacodynamic markers, including refinement of assay conditions, sample volume requirements, and matrix interference.
• Evaluate emerging biomarker technologies and analytical approaches based on their ability to address meaningful development questions.
• Manage and review assay development plans, qualification protocols, qualification reports, and SOPs.
• Assist in the maintenance of critical reagents, qualification of new materials, lot-to-lot bridging, and reference standard lifecycle.
• Oversee clinical biomarker sample testing at CRO partners, including sample logistics and chain of custody, data review, and vendor performance management.
• Define sample collection, processing, shipping, and storage requirements for each sample type.
• Serve as the biomarker representative and point of contact on internal teams, providing strategic biomarker input to program-level decision making based on the specifics of each assay or output of testing.
• Author biomarker sections of clinical protocols, laboratory manuals, or other regulatory documents as needed.
• Maintain accurate and detailed experimental notes in an electronic laboratory notebook or other report systems.

Qualifications

• MS with 6+ years, or PhD with 3+ years, of experience in a laboratory setting performing or managing molecular and/or cell-based experiments.
• Hands-on experience developing and qualifying ligand-binding assays, with demonstrated proficiency in ELISA and MSD electrochemiluminescence methods, including troubleshooting sensitivity, background, matrix, and interference issues.
• Experience overseeing or collaborating on in vitro and in vivo assay design to test gene therapy, small molecule, or protein products.
• Experience taking assays from early development through qualification and into use for nonclinical or clinical sample testing.
• Direct or CRO management experience involving sample testing procedures.
• Preferred: experience supporting programs across multiple stages of clinical development and contributing biomarker content to IND or other regulatory submissions.
• Prior experience documenting laboratory results in written or electronic laboratory notebooks and writing formal study reports.
• Proven problem-solving skills with the ability to adapt to shifting priorities and deadlines.
• Excellent verbal and written communication skills, including a strong command of written English for scientific writing.
• Strong interpersonal skills and the ability to work and communicate effectively within the organization.
• High personal integrity and strong work ethic.
• Ability to operate with substantial latitude in a fast-paced environment.

What happens next

Once you apply, you’ll proceed to next steps if your skills and experience look like a good fit. But don’t worry – even if this position doesn’t work out, you’re still in our network. That means our team of expert Science & Clinical recruiters will have access to your profile, making your opportunities limitless.