Assay Data Management Specialist

• 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

Qualifications :

• Bachelors degree in a scientific technical data management or related field with at least 35 years of industry experience or an M.S. degree with 13 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.

Preferred skills

• 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.

Additional Information :

Position is full-time Monday-Friday 8 a.m. - 5 p.m. weekend work might be expected. Candidates currently living within a commutable distance of Spring House PA are encouraged to apply.

• Excellent full-time benefits including comprehensive medical coverage dental and vision options
• Life and disability insurance
• 401(k) with company match
• Paid vacation and holidays

Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.

Remote Work :

No

Employment Type :

Full-time