R&D Scientist III, Immunoassay Development

Work Schedule

Environmental Conditions

Job Description

Niche Diagnostics within the Clinical Diagnostics Division of Thermo Fisher Scientific, is seeking a highly motivated and innovative professional to join our R&D department in Fremont, California.

As a Scientist in Product Development team, you will drive technical execution across the full In Vitro Diagnostics (IVD) product lifecycle - from concept and feasibility through verification, validation, and commercialization. This role focuses on product development, requiring a skilled experimenter to lead projects independently, collaborate cross-functional teams, and advance products toward successful market launch.

Main Responsibilities:

* End-to-End Assay Development:
Execute technical activities across the product development core phases:
Concept, Feasibility, Planning/Development, Verification, and Validation/Transfer.

* Design Control Proficiency:
Apply rigorous design control and risk management processes; ensure the relationship between design inputs and outputs is maintained so all assay specifications conform to user needs.

* Material Selection & Optimization:
Select and optimize critical components (antibodies, enzymes/conjugates, buffer/matrix composition, stabilizer etc). Develop and refine formulations to meet targeted assay performance characteristics and rigorous stability requirements.

* Verification & Validation Execution:
Design and conduct rigorous studies following recognized standards such as CLSI guidelines for accuracy, precision, sensitivity, linearity, specificity/interference, stability etc.

* Process Development & Scale-up:
Develop, optimize, and characterize robust manufacturing processes for bioconjugates, ensuring scalability and lot-to-lot consistency.

* Design Transfer Support:
Establish preliminary manufacturing/QC processes and specifications for intermediate and finished goods, collaborating cross-functionally to finalize transfer to production.

* Experimental Design:
Translate high-level technical requirements into actionable experimental plans, developing structured protocols with clear evaluation criteria.

* Analytical Problem Solving:
Proactively identify data anomalies, lead comprehensive Root Cause Analysis (RCA), and independently determine and implement effective corrective actions.

* Lab & Data Management:
Utilize advanced laboratory skills to analyze complex datasets, providing data-driven recommendations and strategically planning follow-up testing to meet project milestones.

* Technical Documentation:
Author comprehensive technical reports summarizing study methodologies, data analysis, and scientific conclusions for all development phases. Provide the foundational documentation necessary to support global regulatory filings and successful product registrations.

Keys to Success:

This is a hands-on bench scientist position. The ideal candidate possesses a wide range of specialized experimental techniques, exercises independent judgment in developing new methods, and demonstrates a strong capability for resolving technical issues creatively. You must be an advocate for quality and compliance and possess the interpersonal skills necessary to cultivate high-efficiency collaborations.

Education:

BA/BS or equivalent in a life science discipline with 5 or more years of related experience. MS degree with 3-4 years of related experience. PhD with 2-4 years of experience.

Experience:

* Assay Development:
Proven hands-on experience driving the full lifecycle of IVD assay development, from initial concept through commercialization. Prior experience with Drugs of Abuse (DoA) and/or Therapeutic Drug Monitoring (TDM) is highly preferred.

* Technical Expertise:
Mastery of antigen-antibody interaction-based immunoassay techniques and the analytical methods for antibody characterization and selection is preferred.

* Regulatory & Quality Compliance:
Familiarity with FDA/ISO design controls and global regulatory frameworks, including the U.S. 510(k) pathway and EU IVDR requirements, is preferred.

Knowledge, Skills, Abilities

The following technical laboratory skills are highly preferred:

* Protein Engineering & Production:
Upstream processes, including bacterial transformation, expression optimization, and high-yield harvesting techniques.

* Protein Purification:
Demonstrated skills in developing and executing purification strategies using various chromatography methods to achieve the high-purity standards required for diagnostic reagents.

* Bioconjugation Chemistry:
Chemical conjugation techniques, including the design and execution of enzyme-labeling, hapten-carrier protein coupling, or microsphere coating

* Scientific Storytelling:
Good oral and written communication skills, with the ability to present complex technical data in a clear, concise manner to both technical and non-technical stakeholders.

* Data Analysis & Digital Proficiency:
Proficiency in Microsoft Office Suite and statistical software; ability to perform robust data analysis to support…