Director Technology Transfer

Summary:

The Director, Technology Transfer is responsible for defining and governing the end-to-end technology transfer approach for new and modified clinical assays from Research & Development into regulated clinical laboratory operations at Baylor Genetics. This role owns transfer process design, launch readiness criteria, transfer validation/bridging strategy, and cross-lab standardization to ensure robust, reproducible, and scalable launches. The position serves as a technical liaison between R&D, Clinical Laboratory Operations, Quality, Automation, and Platform/Systems to ensure assays are transferable and implemented consistently, with clear handoffs to operations for steady-state execution.

Qualifications/Experience:

• Education: BS or above in Molecular Biology, Genetics, Genomics, or related discipline.
• Experience:
• 8+ years in clinical laboratory assay development, technology transfer, or operations.
• 3+ years in a supervisory or leadership role.
• Demonstrated success transferring high-complexity molecular or NGS assays into CLIA-certified and/or CAP-accredited laboratories.
• Skills:
• CLIA/CAP regulatory requirements related to assay implementation, validation, SOPs, training, and QC.
• Assay validation principles (accuracy, precision, LOD, reportable range, reference range, QC).

• Change management and governance for process design updates (e.g., readiness criteria, design space parameters, transfer documentation inputs).

• Automation and scalability of wet-lab workflows.
• Data review, troubleshooting, and root-cause analysis.

Duties and Responsibilities:

• Technology Transfer & Assay Implementation
• Lead structured technology transfer of new and modified assays from R&D into clinical production.
• Define transfer scope, readiness criteria, acceptance requirements, and operational handoff.
• Provide operational and compliance input early in assay development to ensure downstream transferability.
• Review assay designs and provide feedback to R&D focused on scalability, robustness, and clinical feasibility.
• Ensure transferred assays meet clinical operational, QC, and compliance expectations prior to go-live.
• Assay Validation Support
• Support clinical assay validations and revalidations, including protocol review, execution support, and data review.
• Provide technical expertise for validation activities.
• Partner with R&D, Quality and Laboratory Directors to ensure validation documentation is complete, accurate, and inspection-ready.
• Support validation-related troubleshooting and assay optimization as needed.
• Clinical Technical Support & Workflow Optimization
• Provide time-bound technical support during transfer, go-live, and defined post-launch hypercare windows; triage complex assay performance issues and route steady-state operational ownership to Lab Ops per established handoffs.
• Define technical requirements and acceptance criteria for critical reagents, controls, and lot qualifications needed for launch; partner with Lab Ops and Quality on execution in accordance with controlled documentation.
• Analyze launch and early post-launch performance to identify design gaps, recommend corrective design changes, and prevent recurrence; support root-cause analysis in partnership with Lab Ops and Quality.
• SOPs, Documentation & Compliance
• Provide design intent, workflow inputs, and technical content to Lab Affairs/Quality for SOPs and controlled documentation associated with newly transferred or modified assays.
• Partner with Lab Affairs to ensure controlled documentation is clear, standardized, and aligned with CAP/CLIA requirements and internal quality systems.
• Partner with Quality and Lab Affairs to support change control and inspection readiness for transferred assays; provide technical assessments and impact analyses for changes that affect the defined design space.
• Automation, Scale-Up & Digital Enablement
• Partner with Automation and Platform/Systems to define requirements and ensure readiness for scalable, automated workflows to support clinical production.
• Identify and document opportunities to reduce manual handling, variability, and error risk through automation and systems enablement; collaborate with Automation and Platform/Systems on implementation.
• Identify opportunities to reduce manual handling, variability, and error risk in assay workflows.
• Training & Knowledge Transfer
• Deliver knowledge transfer and technical onboarding content for newly implemented assays; partner with Lab Affairs/Lab Ops who own training execution and competency assessment.
• Provide technical review of training materials for accuracy and alignment with validated workflows and controlled documentation.
• Serve as a technical escalation resource for complex assay-related questions during transfer and defined post-launch hypercare; support transition of steady-state issue management to Lab Ops.
• Leadership & Best-Practice Tech Transfer
• Lead and mentor the Technology Transfer team, ensuring consistent application of standardized transfer practices.
• Establish and maintain tech transfer best…