Scientist III, Molecular Biology Full-time

Scientist III, Molecular Biology / Systems V&V

The Scientist III, Molecular Biology / Systems V&V will serve as a senior technical contributor within the Platform Verification & Validation team, supporting verification, validation, and change validation activities across molecular biology workflows, sequencing-related applications, companion diagnostic assay testing, and instrument/software-integrated systems.

This role will strengthen senior V&V bench capability by providing flexible technical coverage across multiple project types, including companion diagnostic assay testing, Sanger/NGS sequencing workflows, system-level change validation, instrument change validation, and software upgrade validation for sequencing data analysis applications.

The successful candidate will bring strong hands-on experience in molecular biology workflows, sequencing or sequencing-adjacent applications, system-level V&V, and instrument/software integration. They will be expected to independently design and execute studies, troubleshoot complex workflow and system issues, analyze data, author protocols and reports, provide technical guidance to junior scientists, and manage cross-functional stakeholders with minimal supervision.

This role requires a scientist who is technically strong, adaptable, comfortable operating across different technology platforms, and able to provide senior-level oversight in a fast-paced product development environment.

What will you do?

• Lead and oversee V&V execution for molecular biology workflows, including companion diagnostic assay testing, sequencing-based oncology panels, system-level change validation, instrument change validation, and software upgrade validation.
• Represent the V&V function at the project level and provide technical leadership for test strategy, protocol development, execution, data analysis, deviation assessment, and report generation.
• Translate system requirements, user needs, workflow requirements, and risk considerations into robust V&V plans and test approaches.
• Apply strong understanding of molecular biology workflows, sequencing applications, assay setup, sample preparation, and instrument–workflow interactions to assess system performance, usability, reliability, and robustness.
• Troubleshoot complex cross-functional issues involving assay workflow, instrument hardware, software, consumables, data analysis applications, and user interaction.
• Exercise independent judgment within defined procedures and practices to determine appropriate technical actions, recommendations, and escalation needs.
• Provide technical guidance, coaching, and review support to junior scientists; help build team capability through knowledge sharing and cross-training.
• Independently manage project stakeholders, communicate technical risks, align expectations, and provide clear recommendations to project teams and leadership.
• Recommend and implement improvements to V&V processes, test methods, documentation practices, and team operating efficiency.
• Ensure all work complies with internal procedures, quality system requirements, and applicable regulatory expectations.

How will you get here?

I. Education

• Master's degree in Molecular Biology, Biochemistry, Biotechnology, Life Sciences, Biomedical Engineering, or a related discipline, with at least 4 years of relevant experience.
• Ph.D. in Molecular Biology, Biochemistry, Biotechnology, Biomedical Engineering, or a related discipline, with at least 2 years of relevant industry experience.

II. Experience

• Experience as a technical lead, project lead, or senior contributor in systems V&V, assay workflow validation, instrument development, software-integrated systems, or change validation programs.
• Strong hands-on experience with molecular biology workflows, including sample preparation, assay setup, qPCR, capillary electrophoresis, or sequencing-related applications.
• Good understanding of sequencing-based workflows, including sample preparation, data quality, workflow dependencies, and end-to-end process risks.
• Experience with companion diagnostic assay testing, regulated assay workflow evaluation, or assay/instrument validation is preferred.
• Demonstrated ability to translate system and user requirements into robust V&V plans, test strategies, and test execution.
• Proven ability to troubleshoot cross-functional instrument–workflow issues and assess system performance, reliability, and usability.
• Experience working in multidisciplinary teams and fast-paced product development environments.

III. Knowledge, Skills, Abilities

• Strong understanding of IVD product development processes and regulatory compliance (e.g., ISO 13485, GLP).
• Ability to design and analyze V&V tests to evaluate instrument performance and robustness
• Excellent technical communication and documentation skills for cross-functional stakeholders and leadership.
• Excellent data analysis skills and experience generating high-quality protocols, reports, and technical documentation.
• Strong organizational and project management skills to manage multiple priorities in a fast-paced environment.
• Proficiency with statistical/data analysis tools (e.g., JMP, Minitab) to support testing and decision-making.