Clinical Laboratory Scientist-Senior Andrologist

IVI America•San Francisco, CA

12d•$97,000 - $120,000•Onsite

About The Position

IVI RMA North America is seeking a full-time Clinical Laboratory Scientist (CLS) – Senior Andrologist to join our growing Andrology Department located in San Francisco, California. The Clinical Laboratory Scientist (CLS) – 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, hormone testing, and laboratory quality management while ensuring compliance with California laboratory regulations. Join a highly specialized fertility team where your expertise directly impacts patients on their family-building journey. Unlike traditional hospital laboratory settings, this role offers a more predictable schedule, limited overnight coverage, and a supportive, collaborative environment focused on reproductive medicine. This is an excellent opportunity for an experienced Clinical Laboratory Scientist to grow their career with a global leader in reproductive medicine while making a meaningful difference in patients' lives. 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.

Requirements

Bachelor's Degree or higher in Clinical Laboratory Science, Biology, Biochemistry, Medical Technology, or a related scientific field – required
Active California Clinical Laboratory Scientist (CLS) License issued by the California Department of Public Health (CDPH) – required
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.
Electronic Medical Records (EMR) experience – required
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
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.

Nice To Haves

Master's Degree in a related scientific discipline – preferred
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.
Laboratory Information System (LIS) experience preferred

Responsibilities

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.
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.
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.
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.
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.
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.
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.