Purpose

The Clinical Laboratory Scientist (CLS) – Senior Andrologist serves as the technical and operational leader for the Andrology and Endocrinology Laboratory. This position is responsible for performing advanced diagnostic testing, maintaining regulatory compliance, ensuring laboratory quality standards, supervising laboratory personnel, and supporting fertility treatment through andrology and hormone testing services.

All laboratory testing and procedures must be conducted in accordance with laboratory policies, CAP, CLIA, FDA, OSHA, HIPAA, and California Department of Public Health (CDPH) regulations. Attention to detail, technical expertise, leadership, and commitment to quality patient care are essential to success in this role.

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 specimens, including:
  • TESA
  • PESA
  • Micro-TESE
• Review, validate, and accurately report andrology laboratory testing results.

Endocrinology & Hormone Testing

• Perform and oversee reproductive endocrinology testing related to fertility diagnostics.
• Operate immunoassay analyzers, including Roche Cobas e411, for hormone testing such as:
  • FSH
  • LH
  • Estradiol
  • Progesterone
  • AMH
  • Testosterone
  • hCG
  • Prolactin
• Perform linearity verification and calibration verification (CALVER) according to laboratory validation protocols.
• Conduct and document CAP Proficiency Testing (PT) in compliance with CLIA and CDPH requirements.
• Troubleshoot analyzer performance issues and implement corrective actions as needed.
• Perform routine preventive maintenance, calibration checks, and functional verification of instrumentation.
• 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 CDPH requirements.
• Monitor cryostorage systems and maintain accurate inventory records.

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 studies, and instrument performance evaluations.
• Assist with preparation for CAP, CLIA, FDA, and CDPH laboratory inspections.
• Maintain laboratory documentation, standard operating procedures (SOPs), and quality records.
• Remain current on laboratory operating procedures, quality systems, regulatory standards, and industry best practices.
• Maintain compliance with OSHA safety requirements and infection control procedures.
• Support laboratory inventory management and cost-control efforts while maintaining high-quality laboratory services.

Leadership & Training

• Supervise, mentor, and train andrology laboratory personnel.
• Ensure staff competency assessments and continuing education compliance.
• Participate in hiring, onboarding, and performance management activities.
• Assist in the development, implementation, and revision of laboratory SOPs.
• Participate in internal audits, regulatory inspections, and laboratory readiness activities.
• Promote a culture of quality, collaboration, and continuous improvement.

Clinical Collaboration

• Work closely with reproductive endocrinologists, urologists, embryologists, and nursing staff.
• Provide technical consultation regarding male fertility testing, sperm preparation methods, and endocrine testing results.
• Participate in multidisciplinary patient case discussions and treatment planning.
• Collaborate with multidisciplinary teams to support excellent patient outcomes and achieve laboratory objectives.

General Responsibilities

• Maintain patient confidence and protect operations by keeping all patient and proprietary information confidential in accordance with HIPAA requirements.
• Adhere to all company policies and procedures.
• Perform other duties as assigned to support laboratory and patient care needs.

Academic Training

• Bachelor's Degree or higher in Clinical Laboratory Science, Biology, Biochemistry, Medical Technology, or a related scientific field – required
• Master's Degree in a related scientific discipline – preferred

Licensure

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

Requirements

• Minimum five (5) years of laboratory experience in fertility, andrology, reproductive medicine, or related clinical laboratory environments – required
• Experience performing semen analysis and sperm preparation for ART procedures – required
• Experience performing reproductive endocrinology testing and hormone immunoassay testing – required
• Experience operating and troubleshooting Roche Cobas e411 or similar immunoassay analyzers – required
• Ability to work in a high-volume, fast-paced laboratory environment.
• Ability to communicate clearly and effectively with patients, physicians, and team members.
• Ability to work weekends, early mornings, overtime, and on-call schedules as needed.
• Ability to travel and provide support to satellite laboratory locations when required.
• Excellent organizational, analytical, interpersonal, leadership, and problem-solving skills.

Preferred Qualifications

• Experience working in IVF or Assisted Reproductive Technology laboratories.
• Familiarity with CAP accreditation standards, CLIA requirements, FDA regulations, and CDPH laboratory regulations.
• Experience with instrument validation, proficiency testing programs, and laboratory inspections.
• Previous supervisory or team leadership experience within a clinical laboratory setting.

Technical Skills

• Electronic Medical Records (EMR) experience – required
• Laboratory Information System (LIS) experience preferred
• Proficiency with Microsoft Office Suite (Word, Excel, PowerPoint, Outlook)
• Advanced knowledge of male fertility diagnostics and semen analysis methodologies
• Expertise in ART sperm preparation techniques
• Strong understanding of endocrinology testing and immunoassay instrumentation
• Ability to troubleshoot laboratory equipment and perform technical maintenance
• Thorough knowledge of CAP, CLIA, FDA, and CDPH regulatory compliance requirements
• Strong documentation and quality management skills

Physical Requirements

• Ability to sit at a microscope for extended periods while performing semen analyses and sperm preparation procedures.
• Some standing, stooping, bending, and reaching above shoulder level.
• Moderate lifting of up to 35 pounds.
• Manual dexterity and finger coordination required for pipetting and laboratory procedures.
• Ability to perform repetitive laboratory tasks with precision and accuracy.
• Visual acuity and eye-hand coordination necessary for microscopic evaluations.
• Sensory requirements of speech, touch, vision, and hearing within normal range, with or without correction.
• Must be able to drive and travel between clinical sites as needed.

Environmental Conditions

• Work performed primarily in a temperature-controlled fertility clinic laboratory environment.
• Frequent handling of human reproductive specimens and biological materials.
• Occupational exposure to bloodborne pathogens and potentially infectious materials.
• Exposure to laboratory reagents, liquid nitrogen, cryostorage systems, and electrical laboratory equipment.
• Potential physical hazards including burns, cuts, needle sticks, and equipment-related injuries.
• May require early morning, weekend, holiday, or on-call work depending on clinical schedules.
• Work routines and schedules may occasionally change with limited notice based on patient care needs.