R&D Scientist III, Immunoassay Development

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 data-driven decision-making. Biosafety & Compliance: Experience working safely and effectively with biological materials and hazardous chemicals in a regulated laboratory environment. Team Collaboration & Leadership: Ability to work constructively within cross-functional teams, fostering a collaborative environment to achieve shared project milestones. Operational Excellence: Organizational and time-management skills, with a demonstrated ability to manage multiple competing priorities in a fast-paced R&D setting. Communication Excellence: Proactively communicates with peers, supervisors, and cross-functional partners; pushes “group learning” by sharing technical insights and follow-up. Physical Requirements / Work Environment Controlled Substance Handling: This role involves the handling, management, and oversight of controlled substances. The role will be responsible for ensuring compliance with all relevant regulations and guidelines on controlled substances. Exposure to Controlled Substances: The role may be exposed to controlled substances during their duties. Proper safety protocols and protective measures will be provided and must be strictly followed. Safety Protocols: Ability to adhere to strict safety protocols and procedures to ensure a safe working environment. Background Check: Successful completion of a background check, including screening for any history related to controlled substances. Compensation and Benefits The salary range estimated for this position based in California is $100,000.00–$133,300.00. This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes: A choice of national medical and dental plans, and a national vision plan, including health incentive programs Employee assistance and family support programs, including commuter benefits and tuition reimbursement At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount For more information on our benefits, please visit: #J-18808-Ljbffr Dormont Manufacturing Co