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 LabOps per established handoffs.
- Define technical requirements and acceptance criteria for critical reagents, controls, and lot qualifications needed for launch; partner with LabOps 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 LabOps 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/LabOps 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 LabOps.
- 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 practices, including risk assessment, readiness reviews, definition of the process blueprint/design space, and governance for changes that fall outside approved boundaries.
- Define and track metrics related to transfer success, time-to-launch, and early post-launch performance to inform design improvements and reduce recurrence of launch issues.
- Promote continuous improvement based on clinical performance data and operational feedback.
Competencies:- Scientific and regulatory rigor
- Attention to detail and documentation accuracy
- Structured problem solving and risk management
- Cross-functional collaboration
- Clear written and verbal communication
- Accountability and quality ownership
PHYSICAL DEMANDS AND WORK ENVIRONMENT:- Frequently required to sit.
- Frequently required to stand.
- Frequently required to utilize hand and finger dexterity.
- Frequently required to talk or hear.
