Laboratory Director - Molecular Diagnostics

INTRODUCTION We are a team of doctors, molecular pathologists, and healthcare innovators establishing a state-of-the-art molecular diagnostic laboratory in India. Specializing in oncology, rare genetic disorders, infectious diseases, and precision medicine, our mission is to revolutionize diagnostics through cutting-edge genomic technologies, AI-driven insights, and personalized healthcare solutions. To lead this initiative, we seek a highly experienced pathologist to serve as the Laboratory Director, overseeing clinical operations, regulatory compliance, and quality assurance while also being responsible for final report approvals. This is a key leadership role requiring a strong background in molecular pathology, genetics, or microbiology, along with expertise in clinical laboratory management. JOB SUMMARY The Laboratory Director will be responsible for the overall scientific, technical, and regulatory operations of the molecular diagnostic laboratory. This includes ensuring high-quality test results, compliance with accreditation standards (NABL, CAP, ICMR, CDSCO), and patient safety. The Director will also be legally responsible for signing off on final patient reports, ensuring the accuracy, reliability, and quality of molecular diagnostic testing, and providing expert interpretation of test results. This role demands strong leadership, a deep understanding of molecular diagnostics, and a commitment to advancing precision medicine in India. KEY RESPONSIBILITIES:  1. Laboratory Operations & Quality Assurance

• Oversee day-to-day lab operations, ensuring the delivery of high-quality molecular diagnostics.
• Develop, implement, and maintain Standard Operating Procedures (SOPs) to ensure compliance with NABL, CAP, and other regulatory requirements.
• Ensure quality control and validation of Next-Generation Sequencing (NGS)-based diagnostics and genetic tests.
• Supervise laboratory personnel and ensure adherence to best practices in clinical genomics and molecular testing.

2. Regulatory Compliance & Accreditation

• Ensure compliance with Indian and international regulatory bodies (NABL, CAP, ICMR, CDSCO, ISO 15189).
• Lead certification and accreditation processes for the molecular diagnostic lab.
• Maintain comprehensive documentation for audit readiness and regulatory inspections.

3. Clinical Oversight & Report Sign-Off

• Interpret complex molecular diagnostic test results, including whole genome sequencing (WGS), whole exome sequencing (WES), RNA-Seq, liquid biopsies, and other genomic assays.
• Provide expert clinical correlation of molecular test results in oncology, rare genetic disorders, pharmacogenomics, and infectious diseases.
• Review and sign off on final patient reports, ensuring accuracy, clinical relevance, and adherence to legal standards.
• Work closely with genetic counselors, clinical variant scientists, bioinformaticians, molecular pathologists, oncologists, and other clinicians to provide actionable insights for patient care.
• Develop and validate new molecular diagnostic tests and assays.
• Stay updated with advancements in molecular diagnostics and integrate new techniques and technologies into the laboratory.

4. Research & Technological Advancements

• Drive innovation by integrating AI/ML applications for disease classification and predictive analytics.
• Stay current with advancements in genomics, precision medicine, and bioinformatics to enhance lab capabilities.
• Collaborate with academic institutions and pharmaceutical companies for research and clinical trials.

5. Business Strategy & Stakeholder Engagement

• Provide strategic direction to scale lab services and expand diagnostic offerings.
• Work with the business development team to support market adoption of services and establish partnerships with hospitals, research institutes, and healthcare networks.
• Represent the laboratory at conferences, scientific forums, and industry collaborations.

QUALIFICATIONS AND EXPERIENCE Education

• M.D. in Pathology
• Sub specialization in Molecular Pathology is preferred.

Experience

• 5+ years of experience in molecular diagnostics, clinical genomics, or laboratory management.
• Proven experience in lab accreditation (NABL/CAP) and regulatory compliance.
• Strong track record in leading high-complexity molecular diagnostic labs.

Key Skills

• Expertise in molecular techniques (NGS).
• In-depth knowledge of NABL, CAP, ICMR, and other accreditation standards.
• Strong leadership and team management abilities.
• Clinical interpretation of genomic and molecular test results.
• Ability to work collaboratively in a multidisciplinary environment.
• Ability to perform under high-pressure environments while ensuring accuracy and compliance.

REASONS TO JOIN THE TEAM This is a high-impact leadership role in a cutting-edge molecular diagnostic laboratory, with the mission of transforming healthcare in India. The Laboratory Director will play a pivotal role in establishing, leading, and advancing genomic diagnostics, ensuring both scientific excellence and commercial success. If you are passionate about precision medicine, regulatory excellence, and leading a world-class molecular diagnostics facility, we invite you to be part of this journey.