Assay Development Scientist Jobs in Texas (NOW HIRING)

Technical Transfer and Assay Implementation Scientist

Summary:

As a Tech Transfer/ Assay Implementation Scientistreporting to the Operations Support lead,you willbe responsible forthe onsite validation, implementation, and operationalization of molecular and immunoassay-based assays (qPCR,dPCR, NGS, and ELISA) to support diagnostic testing at the reference laboratories. The R&D and Medical team sets and approves all medical quality expectations, clinical performance thresholds, and assay acceptance criteria; this role executes against those standards and serves as the operational bridge between assay development and routine scalable clinical testing. Protocol development is a shared activity: Medical leads with input and review from this role. Probe, reagent, and equipment decisions with clinical quality implications are made jointly with medicalexpertise.

ZRL operates a cross-functional model in which theMedicalteam owns assay design, acceptance criteria, clinical performance standards, and medical quality oversight, while the Operations Support team owns execution, technology transfer, scalability, and day-to-day operationalization. This role serves as the primary operational interface with theMedicalteam - receiving approved protocols and standards, providing execution feedback and performance data, and collaborating on shared activities such as protocol refinement, SOP development, and training. Decisions with clinical quality implications are made jointly with Medical.

Duties:

Technology Transfer & Implementation

Lead budgeting for assay design experiments, COGs/ROI evaluation during preliminary assay design, and COGs/ROI verification post-implementation to ensure operational cost-effectiveness.

Lead analytical equipmentselectionto support assay implementation and operational scalability

Provide input on material transfer agreements as needed.

Own onsitetechnology transfer and assay implementation into routine diagnostic workflows, serving as the primary operational point of contact for go-live and scale-up activities. This includes transfer of analytical methods from R&D or Medical into routine testing operations, in coordination with theMedicalteam for clinical validation parameters

Lead reagent operationalization and inventory planning during assay transfer to Operations; coordinate handoff to Operations for day-to-day inventory management.

Implement and operationalize molecular and immunoassay-based assays across multiple platforms (qPCR,dPCR, NGS, ELISA) following approved protocols; provide operational input during protocol development; support joint decision-making with Medical and R&D on probes, reagents, and equipment where clinical quality is implicated

Perform hands-on laboratory work including nucleic acid extraction, ELISA plate preparation, assay setup, and workflow optimization

Troubleshoot assay performance issues and interpret complex datasets to ensure high-quality results

Own equipment qualification and operational readiness (IQ/OQ) and execute performance qualification (PQ) for operationsequipment;coordinate with Medical for clinical validation parameters.

Validation & Data Review

Execute and document onsite validation studies per approved protocols; author validation reports, SOPs, and technical documentationin accordance withquality systems; escalate protocol gaps or performance deviations to relevant teams- Operations and Medical for review and approval

Perform first-line review and interpretation of assay data and study results; escalate complex or discrepant findings to theMedicalteam for clinical disposition.

Provide operational performance data and bench-level observations to support annual primer/probe target reviews led by theMedicalteam.

Partner closely with the Medical and R&D team as the scientific collaborator on assay quality, protocol review/approval, and clinical performance expectations; coordinate with quality and bioinformatics to ensure successful and compliant project delivery

Analyze, document, and present experimental data in technical reports and presentations

Quality & Compliance

Develop new assay QC programs under Medical-approved criteria; execute periodic QC review and monitoring, escalatingtrendsor deviations to Medical and Operationsleadership.

Developproficiencytesting programs for new assays under Medical-approved criteria; provide technical consultation duringproficiencytesting execution to ensure ongoing quality.

Provide technical consultation during nonconformance investigations, root cause analyses, and CAPA activities led by the Operations team; contribute subject matterexpertiseon assay performance and workflow factors as needed.

Maintain compliance with applicable regulatory, quality, and biosafety standards (including BSL-2 practices) in all assay implementation activities.

Author andmaintainSOPs and technical documentationin accordance withthe ZRL Quality Management System; coordinatewith Medical on content related to assay performance criteria, result interpretation, and clinical reporting.

Execute reagent and controls assessments for operational performance; provide data and recommendations to Medical for approval.

TrainingandLeadership

Develop training content for new assay execution in coordination with Operations;submitto Medical for approval of clinical and quality components.

Deliver hands-on training for new assay execution, instrument operation, and workflow procedures in coordination with Operations leadership.

Provide scientific leadership as a subject matter expert for molecular and immunoassay operations.

Prepare for and lead internal and external meetings, including project updates and scientific discussions as needed

Serve as a technical resource and subject matter expert for 2-4 molecular lab technicians within Operations

Education/Experience:

Master's or PhD in Life Sciences (e.g., Molecular Biology, Genetics, Genomics, Biomedical Sciences, Biochemistry, or relatedfield)required.

Certification by American Society for Clinical Pathology (ASCP), including MLS(ASCP), MB(ASCP), and DLM(ASCP), is preferred.

Minimum of5+ years in aveterinarydiagnostic environmentor closely related diagnostic/IVD environment.

Familiarity withinfectious disease testing, or serological/ELISA-based diagnostics is a plus

Strong foundationin molecular biology, genetics, and genomics technologies

Hands-on experience in assay development using qPCR,dPCR, NGS, and/or ELISA platforms

Demonstrated experience troubleshootingNGSworkflows and assay performance issuespreferred

Experience working under quality systems (e.g., ISO 13485, CLIA, ISO 17025, AAVLD or similar) preferred

Technical Skills Required:

Proficiencywith data analysis tools and Microsoft Office Suite (Excel, PowerPoint, Word)

Strong analytical thinking and problem-solving skills

Excellent organizational skills with the ability to manage multiple priorities and projects

Effective communication and collaboration skills across multidisciplinary teams

Self-motivated, detail-oriented, and adaptable in a fast-paced environment

Eagerness to learn and applynew technologiesand scientific concepts

Experience withproficiencytesting programs preferred.

Familiarity with laboratory information systems (LIS) and result-reporting workflows preferred.

Physical Position Requirements:

Full-time, onsite position (Monday-Friday)

Laboratory-based role requiring routine bench work

Abilitytolift30lbs.

Travel 10-15%

Full timeRegularColleague

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