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 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.

EEO Statement:

Baylor Genetics is proud to be an equal opportunity employer dedicated to building an inclusive and diverse workforce. We do not discriminate based on race, religion, color, national origin, sex, sexual orientation, age, gender identity, veteran status, disability, genetic information, pregnancy, childbirth, or related medical conditions, or any other status protected under applicable federal, state, or local law.