As part of our ongoing expansion in clinical testing, we are seeking a talented and driven Clinical Technologist III / Senior Technologist to join our innovative team. With sample volumes on the rise and a robust pipeline of new assay development projects, this critical role will support our commitment to the highest standards in test quality, regulatory compliance, and overall operational efficiency. The ideal candidate possesses advanced technical skills, adaptability to a fast-paced startup setting, and a passion for delivering diagnostic insights that enhance patient care and outcomes.

Key Responsibilities:

· Perform high complexity testing under CLIA regulations, including sample accessioning, cell isolation, cell sorting, NGS workflows, QC, and data review.

· Ensure adherence to laboratory SOPs, regulatory standards, and quality control protocols.

· Participate in assay validation, verification, and documentation of laboratory-developed tests.

· Contribute to the implementation and maintenance of a Quality Management System (QMS).

· Assist in the development and refinement of laboratory procedures and workflows.

· Maintain complete and accurate records in accordance with CLIA and other regulatory standards.

· Participate in internal audits, proficiency testing, and ongoing process improvement initiatives.

· Support efforts toward CAP accreditation through accurate documentation and quality practices.

· Collaborate closely with assay development and data analysis teams to ensure seamless handoff and testing execution.

· Provide training and mentorship to junior technologists as needed.

Qualifications:

· Bachelor’s or Master’s degree in Clinical Laboratory Science, Molecular Biology, Biochemistry, or a related field.

· Minimum of 5 years of hands-on experience in a clinical laboratory setting (CLIA/CAP certified lab).

· Strong working knowledge of molecular diagnostic techniques and regulatory requirements (CLIA, CAP).

· Experience participating in assay validations and implementing quality control measures.

· Detail-oriented with excellent organizational and documentation skills.

· Ability to adapt in a dynamic, startup environment and manage multiple priorities.

· Preferred experience with next-generation sequencing (NGS) workflows or flow cytometry in a clinical or research setting.