Manager - Reproductive Medicine Lab

Reproductive Medicine Laboratory Manager

The Manager of the Reproductive Medicine Laboratory provides leadership, direction, and oversight for daily operations across three specialized laboratory disciplines:

• Chemistry (Endocrine Assays): Hormone testing and analyzer operations.

• Andrology: Semen analysis, sperm function testing, and processing for IUI/IVF.

• Embryology: Gamete and embryo handling, culture, cryopreservation, and micromanipulation.

In partnership with the Laboratory Director, this role ensures compliance with all regulatory, accreditation, and professional standards (CDC, FDA, TJC, CAP, CLIA, ASRM, SART) while upholding Henry Ford Health's mission, quality expectations, and Technologies (ART). Performs the duties of a Senior Embryologist.

Principle Duties and Responsibilities:

Quality Management System (QMS) Oversight

1. Develop, implement, and monitor a comprehensive QMS across laboratory operations.

2. Ensure compliance with federal, state, and local regulations, licensing, and accreditation standards (CDC, FDA, TJC, CAP, CLIA, ASRM, SART, OSHA, HIPAA, fire/building codes).

3. Collect, maintain, and report laboratory data annually to CDC/SART

4. Oversee quality control (QC), quality assurance (QA), and quality improvement (QI) programs.

5. Manage documentation, including biennial review and approval of SOPs, policies, and forms.

6. Direct calibration, validation, and maintenance of mission critical laboratory instruments (Incubators, laser microdissection, microscopes, centrifuges, hoods, pipettes, etc.).

7. Direct testing of mission critical alarm systems and notification protocols for incubators, LN semen, oocyte, and embryo storage vessels.

8. Verify staff qualifications, training, and ongoing competency at all levels.

9. Monitor performance metrics across pre-analytical, analytical, and post-analytical phases.

10. Conduct internal audits and implement corrective actions as needed.

11. Maintenance of quality systems training.

Embryology Laboratory Operations

1. Supervise all embryology procedures: patient identification, oocyte retrieval, sperm preparation, IVF/ICSI, fertilization checks, embryo culture, embryo transfer, assisted hatching, biopsy/PGT, cryopreservation, storage, and oocyte-embryo shipment.

2. Ensure adherence to strict quality standards and chain-of-custody protocols.

3. Oversee staff training, competency evaluations, documentation, and performance monitoring.

4. Maintain inventory of critical supplies, media, and cryostorage equipment.

5. Act as an on-site expert for staff, clinicians, and patients.

Andrology Laboratory Operations

1. Oversee semen analysis, sperm function testing, sperm preparation for IUI/IVF, and cryopreservation.

2. Supervise and train testing personnel, ensuring compliance with CLIA '88 Technical Supervisor requirements (BS in Science + 2 years high-complexity testing).

3. Serve as technical and scientific lead for troubleshooting and test validation.

4. Ensure compliance with QC protocols, proficiency testing, and regulatory standards.

5. Review and sign off on test results, reports, and staff competency documentation.

Endocrine Laboratory Operations

1. Direct daily operations of endocrine testing, including environmental checks and analyzer verification.

2. Ensure calibration, reagent verification, and QC monitoring prior to test runs.

3. Review peer comparison data and external QC results to confirm accuracy and reliability of reporting.

4. Maintain compliance with proficiency testing requirements.

Overall Laboratory Management

1. Participate in weekly and ad hoc meetings with the Laboratory Director and staff.

2. Collaborate with physicians, nurses, and scheduling teams to ensure timely and accurate patient care coordination.

3. Support IRB-approved and other clinical research initiatives as assigned.

4. Develop, review, and maintain all laboratory SOPs and policies.

5. Oversee hiring, orientation, training, and evaluation of laboratory staff.

6. Manage laboratory budgets, equipment inventory control, maintenance, and procurement.

7. Represent the laboratory on institutional committees and multidisciplinary service-line initiatives.

8. Promote continuing education, certification, and professional development for staff.

9. Ensure a safe and compliant work environment; monitor adherence to universal precautions and biosafety standards.

10. Investigate and resolve incidents, errors, or patient concerns in coordination with the Laboratory Director.

11. Track and analyze key performance indicators (KPIs) to identify opportunities for process improvement.

12. Lead implementation of new tests, methodologies, and automation solutions.

13. Optimize workflows, staffing, and technology utilization to meet departmental objectives.

14. Provide both technical and operational supervision to ensure laboratory excellence.

Performs the duties of a Senior Embryologist.

Education/Experience Required:

• Bachelor's degree in a biological science. Master's degree preferred.
• Six (6) years of experience in reproductive laboratory operations, including:
• two (2) years in a supervisory or management capacity,
• five (5) years as an Embryologist performing basic and advanced embryology techniques with experience in in-vitro fertilization.
• Demonstrated ability to collaborate effectively with physicians and clinical staff.
• Strong written, verbal, and interpersonal communication skills.
• Proficiency with laboratory information systems and standard office software applications.

Certifications/Licensures Required:

• Must meet CLIA '88 requirements for high-complexity testing.
• Additional ART-related certifications (e.g., ABB, ASCP) strongly preferred but not required.