**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 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: https://jobs.thermofisher.com/global/en/total-rewards
