Company Description

Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins works with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate.

Eurofins is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organisation services. Eurofins is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organisations. The Group also has a rapidly developing presence in highly specialised and molecular clinical diagnostic testing and in-vitro diagnostic products.

In over just 30 years, Eurofins has grown from one laboratory in Nantes, France to 55,000 staff across a decentralised and entrepreneurial network of 900 laboratories in over 50 countries. Eurofins offers a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products.

Job Description

GENERAL JOB DESCRIPTION

The CLIA Microbiology Director shall:

• Support Eurofins Donor & Product Testing business philosophy, leadership values and ethics.
• All employees are expected to meet basic expectations of DPT's quality management system, including, but not limited to good workmanship, adherence to standard operational procedures, training, good documentation practices, accurate recordkeeping so the company may meet its stated quality policy and objectives.
• Responsible for the development and execution of the laboratory structure and organization at each site.
• CLIA regulations require a high complexity laboratory to have a Laboratory Director available to oversee the overall operation and administration of the laboratory
• Responsible for the development and execution of the laboratory structure and organization
• Maintain continuous lab operations with integrity and validity for all laboratory activities

• Responsible for oversight of the Microbiology laboratory leadership team to ensure timely delivery of quality test results, will interact with customers, provide strong technical leadership, and collaborate effectively across groups within the organization ROUTINE BUISNESS OPERATIONS

• Oversees and directs Eurofins DPT Microbiology and Sterility Management

• Focus on strengthening individuals and their capabilities to build a leadership pipeline
• Maintain quality accuracy and ensure all quality monitors meet laboratory objectives
• Enforce applicable policies and procedures throughout the entire laboratory operation
• Develops, implements & enforces laboratory policies, procedures & performance standards affecting wide range of customer entities (Organ Procurement Organizations, Tissue Banks, etc.)
• Work directly with the Director of Laboratory Operations to plan, develop, and drive the vision and strategy of this laboratory to meet the company's set objectives
• Participates in developing new methodologies & tests and develops strategic planning initiatives
• Oversees all laboratory testing and provides scientific expertise to staff for all human related specimens
• Reports critical information to Executive Team, as needed
• Demonstrates passion and enthusiasm for the company's vision, and motivates, leads, and empowers others to achieve company goals
• Evaluate automation of current and new testing platforms based on the needs and capacity of the department
• Pla and have oversight of the implementation of new instrumentation to increase efficiency of laboratory processes
• Recommends new technology/equipment for the laboratory and works within DPT's budget cycle
• Establishes quantitative financial metrics by which the laboratories efficiency and effectiveness can be evaluated; identifies opportunities for improvement (Consumables/personnel as a % of revenue)
• Ensures timely review and approval of all laboratory procedure and safety manuals, review and approval of all proficiency testing results (before submission to vendor and upon receipt of evaluation report) demonstrated by comments, signature/date
• Ensures an annual review of training and competency files and corrective action plans/reports demonstrated by comments, signature/date
• Continuous staffing model assessment and oversight of headcount for the Microbiology department
• Evaluates department personal headcount structure and can prepares justifications for additions
• Ensure that prompt corrective action is taken for all lab audit findings or deficiencies noted
• Serve as a laboratory departmental liaison during regulatory inspections and/or client audits
• Consistent communication with Executive Leadership to ensure they are aware of relevant matters