Clinical Laboratory Scientist Senior Andrologist

Senior Andrologist (California CLS Required) – Fertility Clinic

Job Summary

The Senior Andrologist is responsible for performing and overseeing advanced andrology and reproductive laboratory procedures within a fertility clinic setting. This role supports male fertility evaluation, endocrine testing, and assisted reproductive technologies (ART) by performing semen analyses, sperm preparation, and hormone testing while ensuring compliance with California laboratory regulations.

The Senior Andrologist also supervises andrology laboratory operations, maintains quality control standards, and collaborates closely with reproductive endocrinologists, embryologists, and clinical staff to support patient care.

Key Responsibilities

Andrology Laboratory Testing

• Perform diagnostic semen analysis according to WHO guidelines and laboratory protocols .
• Conduct advanced sperm function testing including:
• Morphology assessment
• Motility and vitality analysis
• Sperm concentration and total motile count
• DNA fragmentation testing when applicable
• Prepare sperm samples for assisted reproductive technologies (ART) including:
• Intrauterine Insemination (IUI)
• In Vitro Fertilization (IVF)
• Intracytoplasmic Sperm Injection (ICSI)
• Process surgical sperm retrieval samples including TESA, PESA, and micro-TESE .

Endocrinology & Hormone Testing

• Perform and oversee reproductive endocrinology testing related to fertility diagnostics.
• Operate immunoassay analyzers including Roche Cobas e411 for hormone testing (e.g., FSH, LH, Estradiol, Progesterone, AMH, Testosterone, hCG, Prolactin).
• Perform linearity verification and calibration verification (CALVER) as required by laboratory validation protocols.
• Conduct and document CAP Proficiency Testing (PT) in compliance with CLIA and CDPH regulations .
• Troubleshoot analyzer performance issues and perform corrective actions as needed.
• Perform routine and scheduled instrument maintenance, calibration checks, and functional verification of the analyzer.
• Monitor assay performance and maintain quality documentation for regulatory inspections.

Sperm Banking & Cryopreservation

• Perform sperm cryopreservation and thawing procedures for fertility preservation and donor banking.
• Maintain specimen tracking and chain-of-custody documentation.
• Ensure compliance with CAP, CLIA, FDA tissue regulations, and California Department of Public Health (CDPH) requirements.

Laboratory Operations & Quality Management

• Maintain compliance with California Clinical Laboratory licensing regulations .
• Implement and maintain laboratory quality assurance and quality control programs .
• Perform method validation, verification, and instrument performance checks .
• Assist with preparation for CAP, CLIA, and CDPH laboratory inspections .
• Maintain laboratory documentation, standard operating procedures (SOPs), and regulatory records.

Leadership & Training

• Supervise and train andrology and laboratory technologists .
• Ensure staff competency and continuing education compliance.
• Assist in development and updates of laboratory SOPs.
• Participate in laboratory audits and regulatory readiness activities.

Clinical Collaboration

• Work closely with reproductive endocrinologists, urologists, embryologists, and nursing staff .
• Provide consultation regarding male fertility testing, sperm preparation methods, and endocrine laboratory results .
• Participate in multidisciplinary patient case discussions and treatment planning.

Required Qualifications

Education

• Bachelor’s degree or higher in Clinical Laboratory Science, Biology, Biochemistry, or related field .

Licensure

• Active California Clinical Laboratory Scientist (CLS) License issued by the California Department of Public Health (CDPH) .

Experience

• 5+ years of laboratory experience , preferably in fertility, andrology, or reproductive medicine laboratories .
• Experience performing semen analysis, sperm preparation for ART, and hormone immunoassay testing .
• Experience operating and troubleshooting Roche Cobas e411 or similar immunoassay analyzers .

Preferred Qualifications

• Experience working in IVF or assisted reproductive technology laboratories .
• Familiarity with CAP accreditation standards, CLIA requirements, and CDPH regulations .
• Experience with instrument validation, proficiency testing programs, and regulatory inspections .

Key Skills

• Advanced knowledge of male fertility diagnostics and semen analysis techniques
• Expertise in ART sperm preparation methods
• Strong knowledge of endocrinology testing and immunoassay instrumentation
• Ability to troubleshoot laboratory instruments and perform technical maintenance
• Thorough understanding of CAP, CLIA, and CDPH regulatory compliance
• Strong attention to detail and laboratory documentation practices
• Effective leadership and communication skills

Work Environment

• Fertility clinic laboratory setting
• Handling of human reproductive specimens and biological materials
• May require early morning, weekend, or on-call work depending on clinical schedules