Eurofins Clinical Diagnostics
Microbiology CLIA Director, Molecular Focused
Eurofins Clinical Diagnostics, Centennial, Colorado, United States
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. In over 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, offering a portfolio of over 200,000 analytical methods.
Job Description General Job Description
Support Eurofins Donor & Product Testing business philosophy, leadership values and ethics.
Meet basic expectations of DPT’s quality management system, including good workmanship, adherence to standard operational procedures, training, good documentation practices, accurate recordkeeping.
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.
Maintain continuous lab operations with integrity and validity for all laboratory activities.
Oversight of the Microbiology laboratory leadership team to ensure timely delivery of quality test results; interact with customers, provide strong technical leadership, and collaborate effectively across groups within the organization.
Routine Business Operations
Oversee and direct 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.
Develop, implement & enforce laboratory policies, procedures & performance standards affecting a wide range of customer entities.
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.
Participate in developing new methodologies & tests and develop strategic planning initiatives.
Oversee all laboratory testing and provide scientific expertise to staff for all human related specimens.
Report critical information to Executive Team, as needed.
Demonstrate passion and enthusiasm for the company's vision, motivate, lead, and empower others to achieve company goals.
Evaluate automation of current and new testing platforms based on the needs and capacity of the department.
Plan and oversee the implementation of new instrumentation to increase efficiency of laboratory processes.
Recommend new technology/equipment for the laboratory and work within DPT's budget cycle.
Establish quantitative financial metrics by which the laboratory’s efficiency and effectiveness can be evaluated; identify opportunities for improvement.
Ensure timely review and approval of all laboratory procedure and safety manuals, proficiency testing results, training and competency files, corrective action plans.
Continuous staffing model assessment and oversight of headcount for the Microbiology department.
Evaluate department personnel headcount structure and prepare justifications for additions.
Ensure prompt corrective action for all lab audit findings or deficiencies noted.
Serve as laboratory departmental liaison during regulatory inspections and/or client audits.
Consistent communication with Executive Leadership to ensure they are aware of relevant matters.
Maintain suitable staffing levels throughout the lab and satellite locations; provide continuous feedback and training; cross‑train microbiological staff to provide consistent and timely services.
Ensure the laboratory passes all audits and maintains appropriate regulatory status.
Ensure adherence to regulatory standards and safety requirements; stay updated on regulatory requirements for the industries served.
Stay abreast on all Quality Event Management items (complaints, deviations, SCARs, CAPAs).
Plan, direct and manage the Sterility and Microbiology Laboratory in all activities related to Microbiology testing to include proper testing, reporting results, test interpretation, development of test methodologies, setting of standards & certification of tests meeting CLIA/CAP certification requirements.
Considerable knowledge of the methods, materials, and techniques used in laboratory work with the ability to aid in troubleshooting of technical problems.
Implement policies and procedures that will improve day‑to‑day operations.
Excellent presentation and cross‑functional team leadership skills; ability to work in close collaboration with others.
Strong organizational and planning skills with strong attention to detail.
Ability to work independently with limited supervision; adapt to change and manage multiple tasks.
Ability to problem‑solve and make decisions on complex issues, often in a cross‑functional team setting.
Critically review laboratory key performance indicators/quality assurance indicators/reactive rates.
Build and maintain relationships with Director of Business Development and Account Executives to make decisions regarding operational activities and goals.
Handle discipline and termination of employees as needed and in accordance with company policy.
Conduct performance evaluations that are timely and constructive.
Create and execute on department strategy with support of Director of Laboratory Operations.
Participate in the hiring and training of managers, supervisors and leads.
Counsel Microbiology management regarding problems encountered in daily operations.
Communicate and explain new directives, policies, or procedures to managers; for major changes, meet with entire operations staff to explain changes, answer questions, and maintain morale.
Minimum Requirements
Must have an M.D., Ph.D., or M.D./Ph.D., be fellowship trained (ABP MM or ASM CPEP) and be board‑certified or board‑eligible in Medical Microbiology by either the American Board of Pathology or American Board of Medical Microbiology.
Must meet the Code of Federal Regulations 493.144:
Be a Doctor of Medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and be certified in anatomic or clinical pathology, or both, by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; OR
Be a doctor of medicine, a doctor of osteopathy or doctor of podiatric medicine licensed to practice medicine, osteopathy or podiatry in the State in which the laboratory is located; and have at least one year of laboratory training during medical residency; OR have at least 2 years of experience directing or supervising high complexity testing; OR
Hold an earned doctoral degree in a chemical, physical, biological, or clinical laboratory science from an accredited institution and; OR
Be certified and continue to be certified by a board approved by HHS; OR
Before February 24, 2003, must have served or be serving as a director of a laboratory performing high complexity testing and must have at least: (A) Two years of laboratory training or experience, or both; and (B) and (B)
Be serving as a laboratory director and must have previously qualified or could have qualified as a laboratory director under regulations at 42 CFR 493.1415, published March 14, 1990 at 55 FR 9538, on or before February 28, 1992; OR
On or before February 28, 1992, be qualified under State law to direct a laboratory in the State in which the laboratory is located;
Minimum 6 years of clinical laboratory testing experience and minimum 5 years of clinical laboratory experience within a supervisory or management role;
Demonstrated knowledge and experience in clinical microbiology;
Significant experience in molecular‑based microbiology laboratory environments including molecular assay implementation and validation activities.
Work Experience Requirements
Experience in the clinical laboratory setting with a strong focus on Microbiology identification methods including molecular identification methods, BioBurden, VDmax, and Sterility testing.
4‑5 years of experience serving as a director of a Clinical Microbiology Laboratory is preferred. Proficient with Laboratory Information Systems and Microsoft Office and experience with analytic data software (e.g., Microsoft BI).
This position requires leadership and management experience to ensure the smooth operation of the large department and expanse of testing.
Excellent communication and interpersonal skills to communicate with a heavy customer focus when working with client leadership and employees.
Knowledge of Federal, CAP, and other regulatory regulations.
Prior experience in a high‑volume environment.
Familiar with new laboratory instrumentation and equipment automation.
Strong working knowledge of operations and expense control.
Previous experience managing multiple locations is highly preferred.
Proven success in training and developing technical employees.
Ability to problem‑solve and provide solutions under minimal supervision.
Strong communication skills; both written and verbal.
High level of attention to detail with strong organizational skills.
Potential Environmental Factors
This laboratory carefully maintains all hazardous materials. All employees must abide by Eurofins DPT’s Safety and Exposure procedures, including using the provided safety clothing and equipment.
For a list of potential chemical hazards, see the appropriate SDS sheet.
Compensation
Salary: $120,000 – $140,000
Additional Information
Schedule: Monday‑Friday 8:00 am – 4:30 pm
What We Offer
Excellent full‑time benefits including comprehensive medical coverage, dental and vision options.
Life and disability insurance.
401(k) with company match.
Paid vacation and holidays.
Eurofins USA Clinical Diagnostics is a Disabled and Veteran Equal Employment Opportunity employer.
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Job Description General Job Description
Support Eurofins Donor & Product Testing business philosophy, leadership values and ethics.
Meet basic expectations of DPT’s quality management system, including good workmanship, adherence to standard operational procedures, training, good documentation practices, accurate recordkeeping.
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.
Maintain continuous lab operations with integrity and validity for all laboratory activities.
Oversight of the Microbiology laboratory leadership team to ensure timely delivery of quality test results; interact with customers, provide strong technical leadership, and collaborate effectively across groups within the organization.
Routine Business Operations
Oversee and direct 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.
Develop, implement & enforce laboratory policies, procedures & performance standards affecting a wide range of customer entities.
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.
Participate in developing new methodologies & tests and develop strategic planning initiatives.
Oversee all laboratory testing and provide scientific expertise to staff for all human related specimens.
Report critical information to Executive Team, as needed.
Demonstrate passion and enthusiasm for the company's vision, motivate, lead, and empower others to achieve company goals.
Evaluate automation of current and new testing platforms based on the needs and capacity of the department.
Plan and oversee the implementation of new instrumentation to increase efficiency of laboratory processes.
Recommend new technology/equipment for the laboratory and work within DPT's budget cycle.
Establish quantitative financial metrics by which the laboratory’s efficiency and effectiveness can be evaluated; identify opportunities for improvement.
Ensure timely review and approval of all laboratory procedure and safety manuals, proficiency testing results, training and competency files, corrective action plans.
Continuous staffing model assessment and oversight of headcount for the Microbiology department.
Evaluate department personnel headcount structure and prepare justifications for additions.
Ensure prompt corrective action for all lab audit findings or deficiencies noted.
Serve as laboratory departmental liaison during regulatory inspections and/or client audits.
Consistent communication with Executive Leadership to ensure they are aware of relevant matters.
Maintain suitable staffing levels throughout the lab and satellite locations; provide continuous feedback and training; cross‑train microbiological staff to provide consistent and timely services.
Ensure the laboratory passes all audits and maintains appropriate regulatory status.
Ensure adherence to regulatory standards and safety requirements; stay updated on regulatory requirements for the industries served.
Stay abreast on all Quality Event Management items (complaints, deviations, SCARs, CAPAs).
Plan, direct and manage the Sterility and Microbiology Laboratory in all activities related to Microbiology testing to include proper testing, reporting results, test interpretation, development of test methodologies, setting of standards & certification of tests meeting CLIA/CAP certification requirements.
Considerable knowledge of the methods, materials, and techniques used in laboratory work with the ability to aid in troubleshooting of technical problems.
Implement policies and procedures that will improve day‑to‑day operations.
Excellent presentation and cross‑functional team leadership skills; ability to work in close collaboration with others.
Strong organizational and planning skills with strong attention to detail.
Ability to work independently with limited supervision; adapt to change and manage multiple tasks.
Ability to problem‑solve and make decisions on complex issues, often in a cross‑functional team setting.
Critically review laboratory key performance indicators/quality assurance indicators/reactive rates.
Build and maintain relationships with Director of Business Development and Account Executives to make decisions regarding operational activities and goals.
Handle discipline and termination of employees as needed and in accordance with company policy.
Conduct performance evaluations that are timely and constructive.
Create and execute on department strategy with support of Director of Laboratory Operations.
Participate in the hiring and training of managers, supervisors and leads.
Counsel Microbiology management regarding problems encountered in daily operations.
Communicate and explain new directives, policies, or procedures to managers; for major changes, meet with entire operations staff to explain changes, answer questions, and maintain morale.
Minimum Requirements
Must have an M.D., Ph.D., or M.D./Ph.D., be fellowship trained (ABP MM or ASM CPEP) and be board‑certified or board‑eligible in Medical Microbiology by either the American Board of Pathology or American Board of Medical Microbiology.
Must meet the Code of Federal Regulations 493.144:
Be a Doctor of Medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and be certified in anatomic or clinical pathology, or both, by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; OR
Be a doctor of medicine, a doctor of osteopathy or doctor of podiatric medicine licensed to practice medicine, osteopathy or podiatry in the State in which the laboratory is located; and have at least one year of laboratory training during medical residency; OR have at least 2 years of experience directing or supervising high complexity testing; OR
Hold an earned doctoral degree in a chemical, physical, biological, or clinical laboratory science from an accredited institution and; OR
Be certified and continue to be certified by a board approved by HHS; OR
Before February 24, 2003, must have served or be serving as a director of a laboratory performing high complexity testing and must have at least: (A) Two years of laboratory training or experience, or both; and (B) and (B)
Be serving as a laboratory director and must have previously qualified or could have qualified as a laboratory director under regulations at 42 CFR 493.1415, published March 14, 1990 at 55 FR 9538, on or before February 28, 1992; OR
On or before February 28, 1992, be qualified under State law to direct a laboratory in the State in which the laboratory is located;
Minimum 6 years of clinical laboratory testing experience and minimum 5 years of clinical laboratory experience within a supervisory or management role;
Demonstrated knowledge and experience in clinical microbiology;
Significant experience in molecular‑based microbiology laboratory environments including molecular assay implementation and validation activities.
Work Experience Requirements
Experience in the clinical laboratory setting with a strong focus on Microbiology identification methods including molecular identification methods, BioBurden, VDmax, and Sterility testing.
4‑5 years of experience serving as a director of a Clinical Microbiology Laboratory is preferred. Proficient with Laboratory Information Systems and Microsoft Office and experience with analytic data software (e.g., Microsoft BI).
This position requires leadership and management experience to ensure the smooth operation of the large department and expanse of testing.
Excellent communication and interpersonal skills to communicate with a heavy customer focus when working with client leadership and employees.
Knowledge of Federal, CAP, and other regulatory regulations.
Prior experience in a high‑volume environment.
Familiar with new laboratory instrumentation and equipment automation.
Strong working knowledge of operations and expense control.
Previous experience managing multiple locations is highly preferred.
Proven success in training and developing technical employees.
Ability to problem‑solve and provide solutions under minimal supervision.
Strong communication skills; both written and verbal.
High level of attention to detail with strong organizational skills.
Potential Environmental Factors
This laboratory carefully maintains all hazardous materials. All employees must abide by Eurofins DPT’s Safety and Exposure procedures, including using the provided safety clothing and equipment.
For a list of potential chemical hazards, see the appropriate SDS sheet.
Compensation
Salary: $120,000 – $140,000
Additional Information
Schedule: Monday‑Friday 8:00 am – 4:30 pm
What We Offer
Excellent full‑time benefits including comprehensive medical coverage, dental and vision options.
Life and disability insurance.
401(k) with company match.
Paid vacation and holidays.
Eurofins USA Clinical Diagnostics is a Disabled and Veteran Equal Employment Opportunity employer.
#J-18808-Ljbffr