Nemametrix, an actively growing company in the biotechnology product and services industry is seeking an experienced Laboratory Director. We are transitioning our industry-defining assays into a new lab, focused on providing services and data in regulated or “near-regulated” applications. The Lab Director, in coordination with our senior management, will be responsible for developing the strategies and goals for the lab, for performance oversight and for ensuring compliance to all necessary standards and regulations. This is a fantastic opportunity to create and build high-functioning team from the ground up.
Vice President of Operations
The Laboratory Director establishes the strategies and tactics to achieve Nemametrix’s financial and strategic goals. The incumbent will have performance and compliance responsibilities for all functions in the lab. To support this, the Director will be responsible for establishing the hiring needs (capacity and skills) for the lab. One of the most critical and urgent activities will be to ensuring proper transference of methods and procedures from our R&D teams into the to-be-formed Operations lab team.
Responsibilities and Duties
The Laboratory Director will be a critical member of the Operations team, responsible for developing, implementing and managing all aspects of our phenotyping assay throughput capabilities.
- Minimum 4 years CLIA, FDA or similar laboratory management experience, possesses a Bachelor’s degree in related area
- A detailed, professional, and results-oriented attitude with strong analytical and decision-making skills
- Demonstrated change-management and/or organizational behavior skills
- Ability to effectively communicate with other team members
- High level of initiative and work well in a team environment
- Strong project management skills. Able to balance competing priorities, complex situations, and tight deadlines
- Working knowledge of ISO 13485, ISO 15189, 21CFR sections 1-11 or similar standards
- Excellent written, verbal, and interpersonal communications skills
- Strategic oversight and performance responsibilities of laboratory operations
- Guide company leadership team on compliance and regulatory requirements
- Develops innovative efforts to enhance internal efficiency and effectiveness
- Supports company initiatives through strategic and operational guidance and by ensuring that required infrastructure and support services are in place
- Ensures compliance, reviews, identifies, investigates, and resolves Quality Improvement Reports, internal audit findings, and external audit findings. Makes SOP changes as needed.
- Assists with the development, maintenance and monitoring of organizational plans
- Assists with the development and management of integrated, strategy-aligned departmental work plans
- Assists with the development and management of the annual operating and capital budgets