Senior Embryologist

Job Title: Senior Embryologist / Clinical Applications Specialist.

Department: IVF.

Location: Vapi, Gujarat.

Reports To: IVF Head.

Job Purpose:

To lead and manage embryology laboratory operations by performing advanced Assisted Reproductive Technology (ART) procedures, ensuring laboratory quality, regulatory compliance, clinical excellence, and successful patient outcomes. The role also serves as a scientific and clinical liaison with IVF specialists, Key Opinion Leaders (KOLs), and healthcare professionals while supporting product evaluation, clinical applications, research, and innovation.

Key Responsibilities:

1. Clinical Embryology

• Independently perform advanced ART laboratory procedures including Conventional IVF, ICSI, IMSI, PICSI, Assisted Hatching, Blastocyst Culture, Trophectoderm Biopsy (PGT-A/PGT-M/PGT-SR), Oocyte & Embryo Vitrification, Warming Procedures, and Embryo Transfer Preparation.
• Perform oocyte identification, denudation, maturity assessment, fertilization assessment, embryo grading, and embryo selection.
• Independently perform complex micromanipulation procedures.
• Handle donor IVF programs, fertility preservation, and oncofertility cases.
• Ensure complete traceability and accurate witnessing of gametes and embryos using electronic or manual witnessing systems.

2. Andrology Services

• Perform semen analysis in accordance with WHO guidelines.
• Process semen samples using Density Gradient and Swim-Up techniques.
• Perform surgical sperm processing including PESA, TESA, TESE, and Micro-TESE specimens.
• Manage sperm cryopreservation and thawing procedures.
• Support male fertility diagnostic and laboratory procedures.

3. Laboratory Operations & Quality Management

• Supervise day-to-day embryology laboratory operations.
• Plan laboratory workflow and optimize resource utilization.
• Implement and maintain Quality Management Systems (QMS).
• Monitor laboratory environmental parameters including CO₂, O₂, temperature, humidity, VOCs, particulate counts, incubator performance, and cryostorage systems.
• Perform Quality Control (QC), Quality Assurance (QA), method validation, media validation, environmental monitoring, CAPA, Root Cause Analysis, Risk Assessment, and Internal Audits.
• Prepare and update SOPs, laboratory records, validation reports, and documentation.
• Ensure laboratory readiness for accreditation and regulatory inspections.

4. Equipment Management & Validation

• Operate, maintain, and troubleshoot advanced IVF laboratory equipment including:
• Inverted Microscopes
• Micromanipulators
• Laser Systems
• Time-Lapse Incubators
• Tri-Gas Incubators
• CASA Systems
• Cryopreservation Equipment
• IVF Workstations
• Laminar Air Flow Systems
• Electronic Witnessing Systems
• Laboratory Information Management Systems (LIMS)
• Coordinate preventive maintenance, calibration, equipment qualification (IQ/OQ/PQ), and vendor service activities.

5. KOL, Doctor & Clinical Relationship Management

• Develop and maintain strong professional relationships with Key Opinion Leaders (KOLs), IVF specialists, Obstetricians & Gynaecologists, Reproductive Endocrinologists, Andrologists, clinicians, embryologists, and IVF centres.
• Act as the primary scientific and clinical liaison between the organization and healthcare professionals.
• Conduct scientific discussions, product presentations, and clinical demonstrations.
• Support product evaluations, validations, and adoption of new IVF technologies and laboratory solutions.
• Organize and deliver workshops, hands-on training programs, webinars, symposiums, and Continuing Medical Education (CME) activities.
• Collaborate with Sales, Marketing, Clinical Affairs, Regulatory Affairs, and R&D teams to support customer engagement and scientific communication.
• Gather clinical feedback and market insights to support product development and continuous improvement.
• Represent the organization at national and international conferences, scientific meetings, and professional forums.

6. Research, Innovation & Clinical Applications

• Participate in clinical research, scientific publications, and product validation studies.
• Evaluate emerging ART technologies, laboratory equipment, culture media, and consumables.
• Support new product development, clinical evidence generation, and technology implementation.
• Promote evidence-based adoption of innovative ART technologies across partner IVF centres.

7. Leadership, Training & Regulatory Compliance

• Mentor and supervise Junior Embryologists, Laboratory Technicians, and trainees.
• Conduct competency assessments and technical training programs.
• Ensure compliance with ICMR ART Guidelines, ART Act & Rules, ESHRE Guidelines, ASRM Recommendations, NABH Standards, Biomedical Waste Management Rules, ISO 15189, ISO 13485, and Good Laboratory Practices (GLP).
• Foster a culture of quality, patient safety, ethics, and continuous improvement.

Qualifications and Experience:

• M.Sc. in Clinical Embryology, Reproductive Biology, Biotechnology, Life Sciences, or related discipline.
• ESHRE Clinical Embryologist Certification / ICMR Certification or equivalent (Preferred)

Skills and Competencies:

• Expertise in IVF, ICSI, Blastocyst Culture, Embryo Grading, Trophectoderm Biopsy, and Cryopreservation.
• Strong knowledge of embryology laboratory operations and quality management systems.
• Hands-on experience with advanced IVF laboratory equipment and electronic witnessing systems.
• Excellent laboratory troubleshooting and analytical skills.
• Strong leadership, mentoring, and team management capabilities.
• Excellent communication, scientific presentation, and customer engagement skills.
• Ability to build and manage relationships with KOLs, doctors, and IVF centres.
• Knowledge of ART regulations, accreditation standards, and medical device quality systems.
• Willingness to travel for customer visits, scientific meetings, training programs, and conferences.

Key Performance Indicators (KPIs):

• Fertilization, Blastocyst Formation, Implantation, Clinical Pregnancy, and Live Birth Rates.
• Cryosurvival and Biopsy Success Rates.
• Zero Patient Identification or Traceability Errors.
• Compliance with Quality Management Systems, SOPs, and Regulatory Standards.
• Laboratory Audit Readiness and Successful Accreditation Outcomes.
• Timely Equipment Calibration, Validation, and Maintenance.
• Customer Satisfaction and Effective KOL/Doctor Engagement.
• Number of Clinical Trainings, Workshops, and Scientific Programs Conducted.
• Successful Product Evaluations and Technology Adoption.
• Team Competency Development and Continuous Laboratory Improvement.

Skills Required
cryopreservation , ICSI