Assay Data Management Specialist

Eurofins USA PSS Insourcing Solutions•Spring House, PA
•Onsite

About The Position

Embed within the data management and project teams supporting the onboarding and implementation of new bioanalytical assays. Partner with scientists and subject matter experts to understand assay workflows, rules, calculations, data requirements, and execution processes. Gather, clarify, organize, and document scientific and operational requirements needed to support assay execution, data capture, and data analysis. Develop and configure templates and assay preparations required to support assay execution, data capture, and analysis. Support both manual and automated/robotic assay implementations. Participate throughout the end-to-end template development lifecycle, from requirements gathering and documentation through configuration, testing, implementation, and refinement. Review and interpret applicable requirements specifications to ensure requirements are appropriately reflected in templates and project deliverables. Compare requirements and workflows across assays and projects to identify gaps, differences, and opportunities for standardization. Collaborate with scientists, data management, IT, and other stakeholders to translate scientific and operational requirements into effective assay-supporting solutions. Develop sufficient understanding of assay-specific rules and workflows to identify expected template behavior, potential gaps, and appropriate test scenarios. Prepare test cases and UAT scripts throughout the template development process and participate in UAT, including documenting and resolving identified issues. Confirm that templates, assay preparations, and related deliverables accurately support intended assay workflows and data requirements. Maintain appropriate documentation of requirements, decisions, configurations, testing activities, and project deliverables. Support multiple assay projects simultaneously and identify opportunities to improve consistency, efficiency, usability, and quality across assay onboarding activities. Assist with interpretation of clinical protocols to accurate data entry during study design.

Requirements

  • Bachelor's degree in a scientific, technical, data management, or related field with at least 3–5 years of industry experience, or an M.S. degree with 1–3 years of related experience.
  • Experience in bioanalysis, laboratory operations, scientific data management, laboratory informatics, or a related field.
  • Demonstrated ability to understand scientific workflows and translate them into practical template, data-capture, or data-management requirements.
  • Experience collaborating across scientific, data management, technical, and project teams.
  • Strong organizational skills with the ability to manage multiple concurrent projects and deliverables.
  • Strong written and verbal communication skills.
  • Highly detail-oriented with a focus on accuracy, consistency, quality, and successful implementation.
  • Ability to work independently while effectively collaborating within cross-functional teams.

Nice To Haves

  • Experience with Benchling or similar scientific data management platforms.
  • Experience supporting bioanalytical or laboratory assay onboarding.
  • Experience with both manual and automated/robotic assay workflows.
  • Experience building or configuring templates, assay preparations, workflows, or similar scientific data-management components.
  • Experience working collaboratively with scientists, data management professionals, IT, and other technical teams.
  • Familiarity with requirements specifications and translating requirements into functional project deliverables.
  • Experience developing test cases and UAT scripts and participating in UAT activities.
  • Experience working in a regulated or quality-focused laboratory environment.
  • Familiarity with scientific data-management or software implementation lifecycles.
  • Experience supporting process standardization or continuous improvement activities.

Responsibilities

  • Support the onboarding and implementation of new bioanalytical assays.
  • Partner with scientists and subject matter experts to understand assay workflows, rules, calculations, data requirements, and execution processes.
  • Gather, clarify, organize, and document scientific and operational requirements.
  • Develop and configure templates and assay preparations.
  • Support manual and automated/robotic assay implementations.
  • Participate in the end-to-end template development lifecycle.
  • Review and interpret requirements specifications.
  • Compare requirements and workflows across assays and projects.
  • Collaborate with scientists, data management, IT, and other stakeholders.
  • Develop understanding of assay-specific rules and workflows.
  • Prepare test cases and UAT scripts and participate in UAT.
  • Confirm that templates, assay preparations, and deliverables support intended assay workflows and data requirements.
  • Maintain documentation of requirements, decisions, configurations, testing activities, and project deliverables.
  • Support multiple assay projects simultaneously.
  • Identify opportunities to improve consistency, efficiency, usability, and quality.
  • Assist with interpretation of clinical protocols for accurate data entry during study design.

Benefits

  • Comprehensive medical coverage
  • Dental options
  • Vision options
  • Life insurance
  • Disability insurance
  • 401(k) with company match
  • Paid vacation
  • Paid holidays
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