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LEAD EMBRYOLOGIST
Job Title: LEAD EMBRYOLOGIST
Job Code: 4669
FLSA: N
Job Level: H1
Revised Date: 08/01/2026
Supervisory Responsibility: Yes
General Description of the Job Class
The Lead Embryologist is the operational leader of the human in-vitro fertilization (IVF) laboratory, accountable for daily lab operations, regulatory compliance, quality assurance and improvement (QA/QI), and the technical development of the embryology team. The Lead holds formal supervisory authority over Senior Embryologists and Embryologists. Senior Embryologists are expected to train junior staff, but supervision, development, and performance management are Lead-level accountabilities. The Lead authors laboratory SOPs and validation protocols, owns compliance with all applicable accrediting agencies (SART/CDC, CAP, CLIA, FDA, JCAHO), audits lab records, and serves as the primary technical liaison to the Laboratory Director. The Lead is assigned complex and abnormal case types requiring a high level of autonomy in analysis and communication of findings, serves as the escalation point for lesser-complex cases supported by Senior Embryologists and Embryologists, and escalates to the Laboratory Director or designee when required.
Duties and Responsibilities of this Level
Complex Technical Procedures and Case Ownership:
- Oversight of complex assisted reproductive procedures, including performance, validation, and final sign-off on non-routine cases.
- Assigned complex/abnormal case types (i.e., multi-case, high ambiguity) and expected to utilize a high level of autonomy in the analysis and communication of findings. If escalation is needed, must contact the Laboratory Director.
- Serve as the point of contact for escalations of lesser-complex case types supported by the Senior Embryologists and Embryologists.
Laboratory Operations:
- Lead daily embryology laboratory operations, ensuring efficiency, accuracy, and consistency of workflow.
- Ensure strict adherence to laboratory protocols amongst staff, maintaining accurate gamete and embryo traceability at all times.
- Verify accuracy of incoming and outgoing shipments of gametes and embryos and approve BabySentry checklist for shipments.
- Manage appropriate storage, inventory control, and billing protocols for frozen specimens; monitor laboratory equipment performance.
Reporting and Analytics:
- Prepare reports and analyses for the Laboratory Director outlining performance metrics, trends, adverse events, and recommendations.
- Lead SART/CDC submissions and adverse event reporting.
Laboratory Compliance Ownership and QA/QI:
- Ownership over laboratory compliance for all regulatory and accrediting agencies (SART/CDC, CAP, CLIA, FDA, JCAHO).
- Design, develop, and participate in Quality Assurance and Quality Improvement initiatives in alignment with the laboratory's Quality Management Plan.
- Audit embryology and andrology records completed by laboratory staff and recommend improvements as needed.
- Author laboratory SOPs and validation protocols.
- Point of contact for regulatory surveyors during CAP, CLIA, and FDA inspections.
Research Liaison and New Technique Introduction:
- Maintain up-to-date knowledge of current developments and research within the clinical area of fertility specialty. Present findings and recommendations to the Laboratory Director regarding process improvements.
- Serve as a liaison to Clinicians and Fellows to determine feasibility in research project participation and assistance in studies. Assign research projects to lower-level staff, based on proficiency and operational needs/constraints.
Proactive management of daily clinical operations. Oversee and train lower level staff.
Perform other related duties incidental to the work described herein.
Required Qualifications at this Level
Education
Bachelor's degree in Biology, Zoology, Biochemistry or other related scientific field.
Experience
Minimum 6 years of clinical/research experience within a reproductive lab and/or andrology lab, including 2 years at the Senior Embryologist level or equivalent. An advanced degree (Master's or PhD) in biology, zoology, biochemistry, reproductive biology, embryology, or a related scientific field may substitute for 1 year of the required experience.
Preferences: ABB Technical Supervisor (TS) certification.
Degrees, Licensure, and/or Certification
N/A
Knowledge, Skills, and Abilities
Demonstrated ability to formally supervise technical staff, including performance management and development planning
Experience authoring laboratory SOPs and validation protocols
Experience leading QA/QI programs in a CAP/CLIA-regulated environment
Experience as primary point of contact for regulatory audits
Strong clinical judgment for complex case validation and final sign-off.
Strong leadership presence and skills.
Ability to communicate clearly with patients, families, visitors, healthcare team, physicians, administrators, leadership and others.
Ability to analyze, evaluate multiple solutions and solve complex problems using well developed critical & analytical thinking skills.
Remains informed of changing technologies and protocols.
Willingness to adapt to high pace and fast changing situations.
Mastery of all technical andrology and embryology procedures, as outlined below:
Technical andrology procedures: Daily QC, Semen volume assessment, Measurement of pH, viscosity and granulocytes, Semen preparation for sperm chromatin structure assay Sterile technique, Sperm concentration assessment, Sperm motility assessment, Sperm morphology assessment, Density gradient centrifugation, Simple wash semen preparation, Microfluidic sperm sorting technologies, Preparation of samples for Intrauterine Insemination, Sperm cryopreservation, Post-thaw analysis , Viability assessment, Processing samples from: Testicular sperm extraction, Percutaneous epididymal sperm aspiration, Micro-TESE, and Isolation of viable sperm from processed surgical samples.
Technical embryology procedures: Daily QC, Culture preparation, Sterile Technique, Embryo culture, Sperm preparation (conventional), Sperm preparation (ICSI), Oocyte maturity assessment, Fertilization assessment post ICSI, D3 embryo assessment, D5-7 embryo assessment, Oocyte preparation - denudation, Oocyte preparation - activation/calcium ionophore, Conventional insemination, Fertilization assessment post conventional insemination, Assisted hatching, Embryo transfer procedure, Embryo vitrification, Embryo warming, ICSI, Oocyte vitrification, Oocyte warming, Embryo biopsy, Biopsy tubing, PGT case handling, and new- technique validation and introduction.
Distinguishing Characteristics of this Level
The intent of this job description is to provide a representative and level of the types of duties and responsibilities that will be required of positions given this title and shall not be construed as a declaration of the total of the specific duties and responsibilities of any particular position. Employees may be directed to perform job-related tasks other than those specifically presented in this description.
Duke University is an Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, gender, gender expression, gender identity, genetic information, national origin, race, religion, (including pregnancy and pregnancy related conditions), sexual orientation, or military status.
Duke aspires to create a community built on collaboration, innovation, creativity, and belonging. Our collective success depends on the robust exchange of ideas-an exchange that is best when the rich diversity of our perspectives, backgrounds, and experiences flourishes. To achieve this exchange, it is essential that all members of the community feel secure and welcome, that the contributions of all individuals are respected, and that all voices are heard. All members of our community have a responsibility to uphold these values.
Essential Physical Job Functions
Certain jobs at Duke University and Duke University Health System may include essential job functions that require specific physical and/or mental abilities. Additional information and provision for requests for reasonable accommodation will be provided by each hiring department.
