Director, Laboratory Operations

ClearPoint Neuro, Inc.; San Diego (CA); Sur place; USD 180 000 - 240 000; Plein temps

Résumé du poste

ClearPoint Neuro, Inc. is seeking a Director of Laboratory Operations to lead on-site lab activities in San Diego, ensuring safety, efficiency, and regulatory compliance.

You will manage staff, budgets, and cross-functional collaboration to support translational research, device and gene therapy initiatives, and clinical programs. The role requires a terminal degree in a related field, with proven leadership in regulated labs, Q&C programs, and experience with audits.

Qualifications

• Oversee daily laboratory operations and safety practices.
• Ensure data integrity, QA/QC programs, and regulatory compliance.

Responsabilités

• Budget for laboratory operations and resources.
• Support audits/inspections and prepare for regulatory reviews.
• Serve as Radiation Safety Officer for radiochemistry lab and in vivo RAM operations.
• Guide cross-functional teams to support product development and clinical initiatives.
• Drive continuous improvement of laboratory performance and reliability.

Connaissances

Lab operations

Quality assurance

Regulatory compliance

Leadership

Audits & inspections

Translational research

Communication

Documentation

RSO experience

Formation

Terminal degree in a related field

Description du poste

Company Description

ClearPoint Neuro, Inc. is a device, cell, and gene therapy-enabling company focused on precise navigation to the brain and spine. The company offers both established clinical products and pre-clinical development services that support controlled drug and device delivery. ClearPoint Neuro collaborates with healthcare and research centers across North America, Europe, Asia, and South America. The organization is driven by a mission to improve and restore quality of life for patients and families by enabling therapies for complex neurological disorders with pinpoint accuracy. Team members contribute to advancing innovative solutions that bridge cutting-edge research and clinical practice.

Role Description

The Director, Laboratory Operations is a full-time, on-site role based in San Diego, CA. This role oversees daily laboratory activities, ensuring safe, efficient, and compliant operations aligned with company standards and regulatory requirements. Responsibilities include managing laboratory staff, setting performance expectations, and optimizing workflow, resources, and equipment utilization. The Director develops and implements laboratory policies and procedures, monitors quality control and quality assurance programs, and collaborates with cross-functional teams to support product development and clinical initiatives. The role also involves budgeting for laboratory operations, supporting audits and inspections, maintaining accurate documentation, and driving continuous improvement initiatives to enhance laboratory performance and reliability. This person will serve as the radiation safety officer (RSO) for our radiochemistry laboratory and in vivo RAM operations. Prior experience with radioactive materials is highly desired.

Qualifications

• Strong laboratory operations and Laboratory Skills, including experience overseeing routine procedures, equipment maintenance, and safety practices.
• Expertise in Quality Control and Quality Assurance, with a track record of implementing and monitoring programs that ensure data integrity and regulatory compliance.
• Background in translational research, with the ability to guide technical work and interpret laboratory results to support research.
• Proven leadership experience managing laboratory teams, setting goals, and fostering a collaborative, inclusive, and safety-focused environment.
• Knowledge of applicable regulatory standards (e.g., CLIA, CAP, FDA, etc.) and experience preparing for and supporting audits and inspections.
• Strong organizational, analytical, and problem-solving skills, with the ability to prioritize multiple projects and meet deadlines.
• Excellent written and verbal communication skills for documentation, reporting, and cross-functional collaboration.
• Terminal degree in a relevant scientific or medical discipline (e.g., Laboratory Science, Microbiology, Biomedical Science) is required.
• Experience in neuro-related, medical device, or cell and gene therapy environments is a plus.