Position Overview

The Senior Director of Laboratory Operations will lead and manage the production of molecular testing products in our high-complexity molecular laboratory, in Waltham, MA. This candidate will supervise the delivery of high-quality, efficient, and innovative molecular diagnostic services to BostonGene customers, collaborators, and internal R&D projects. This role demands a seasoned leader with deep expertise in molecular biology, particularly in high-throughput next generation sequencing, and a proven track record in operational management. The ideal candidate will be responsible for driving continuous production of high quality data in the lab, organizing the lab space for maximum efficiency, ensuring compliance with regulatory standards, and fostering a culture of excellence and continuous improvement.

Key Responsibilities:

• Leadership and Strategy:

Develop and implement strategic operational plans to support the laboratory’s clinical and research goals.

Lead and mentor a multidisciplinary team, including scientists, technologists, and bioinformaticians, to achieve high performance and foster innovation.

Cultivate a culture that emphasizes quality, collaboration, and forward-thinking.

• Operational Management:

Oversee daily laboratory operations, including sample processing, sequencing, quality control, and data analysis.

Ensure compliance with all regulatory requirements, maintaining the highest standards of laboratory practice.

Continuously evaluate and optimize workflows to improve efficiency, reduce costs, and enhance data quality.

• Quality Assurance:

Establish rigorous quality control measures and maintain comprehensive quality assurance processes.

Monitor performance metrics and implement corrective actions to address any deviations from quality standards.

Resolve technical challenges to minimize operational disruptions and maintain continuity.

• Technology and Innovation:

Stay current with advancements in molecular diagnostic technologies and integrate new methodologies into laboratory operations.

Collaborate with research and development teams to translate innovative solutions into clinical practice.

• Budget and Resource Management:

Manage the laboratory’s operational budget, ensuring cost-effectiveness and resource optimization.

Oversee procurement, maintenance, and calibration of laboratory equipment and supplies.

Identify opportunities for cost savings without compromising the quality of services.

• Cross-Functional Collaboration:

Work closely with clinical, research, and bioinformatics teams to ensure seamless integration of molecular diagnostic data into patient care and research initiatives.

Engage with external partners, vendors, and regulatory agencies as required to support laboratory operations.

Preferred Skills:

Operational Excellence: Strong operational management skills, with experience in streamlining workflows and improving laboratory efficiency. From sample receipt and accessioning to diagnostic report delivery.

Leadership & Team Management: Demonstrated ability to lead and train multidisciplinary teams to deliver on complex projects with multiple stakeholders in a dynamic environment.

Regulatory & Quality Management: Deep knowledge of regulatory requirements and quality assurance standards in clinical diagnostics and clinical trials.Practical knowledge of applying CAP/CLIA/GXP standards to day-to-day operations.

Technical Expertise: Experience in high-complexity molecular testing, particularly next-generation sequencing (NGS) molecular diagnostics, and a working knowledge of histology/imaging, and cytology/cytometry methods.

Qualifications:

A minimum of 10 years of experience in molecular diagnostics, with at least 5 years in a leadership role.

Background in molecular biology, clinical genomics, bioinformatics or a related field.

Track record of building, optimizing, and maintaining multiple diagnostic workflows in a clinical setting with an emphasis on speed and cost control.

Proven experience in high-throughput, high-complexity laboratory testing production and product development.

Strong communication, leadership, and interpersonal skills, with a focus on driving team success in a fast-paced environment.

About BOSTONGENE:

BostonGene Corporation pioneers biomedical software for advanced patient analysis and personalized therapy decision-making in cancer treatment. Our solution integrates cutting-edge cancer research and clinical data to empower clinicians in tailoring optimal treatment strategies for individual patients.