The Director of Laboratory Operations is responsible for the overall operations of the clinical laboratory and the supervision of laboratory personnel. The high complexity nature of the work requires excellent attention to detail, effective written and verbal communication skills, the ability to multi-task and be flexible with tasks and schedules, and the ability to work independently in a team environment.
The Director of Laboratory Operations must also act as a liaison between the laboratory staff and the Product Development, Automation, Research, Bioinformatics, Software and Materials Management groups. The Director of Laboratory Operations must exhibit leadership skills such as good judgment, sound analysis and decision making, the ability to remain professional and composed under pressure, effective interpersonal skills, and the ability to effectively communicate across all levels of the laboratory and across departments.
The Director of Laboratory Operations will also be involved with troubleshooting high complexity technical and non-technical problems, coaching and mentoring, building effective teams, managing projects and meeting project deliverables, and understanding and implementing laboratory goals. Given the wide variety of tasks involved in this position, the Director of Laboratory Operations must demonstrate the ability to analyze complex issues and make sound decisions in a timely manner, commitment to helping and motivating employees, the ability to respond to difficult issues quickly, fairly, and ethically, outstanding organizational skills, the ability to respond to change with flexibility and to adapt quickly to evolving circumstances, and excellent communication skills including proactively communicating team goals and priorities clearly, openly and objectively, and communicating changes, issues, and challenges in all directions of the organization.
- Oversee the overall operations of the Clinical Laboratory including planning, directing and evaluating all laboratory activities within the facility.
- Ensure test systems are functioning properly, monitoring patient and quality control testing results, planning, validation and implementation of new test procedures.
- Collaborate with the Laboratory Managers on the laboratory’s quality control and quality assurance procedures, technical troubleshooting and improvement procedures, and training and education programs. Lead and participate on cross functional teams responsible for implementation of new products, process improvements, and troubleshooting activities in the clinical laboratory.
- Ensure stability studies, validation protocols, and other process improvement and new assay projects are implemented per protocol.
- Lead and participate on cross functional teams responsible for securing CLIA certification, CAP accreditation, and state licensure for the GRAIL Clinical Laboratory, including compliance with all applicable standards and regulations.
- Review validation and stability study protocols and technical reports.
- Participate in quality assurance activities.
Your Background Should Include:
- California Clinical Laboratory Scientist license.
- Bachelor of Arts or Science in Biomedical Laboratory Science, Clinical Science or related field.
- At least seven (7) years of Laboratory experience or equivalent.
- Working knowledge of local, state, and federal laboratory regulations.
- Operations and people management experiencerequired.
- Strong project management abilities.
- Strong collaborator and demonstrated track record of success in a cross functional team environment and management roles.
- Strong technical skills in molecular biology and other relevant industry knowledge.
- Strong automation and computing skills.
- Ability to effectively communicate technical information to technical and non-technical audiences.
- Ability to proactively communicate consistently, clearly, and honestly.
- Experience with next generations sequencing and sample preparation a plus.