Eurofins BioPharma Product Testing Ireland, Ltd.
Microbiology CLIA Director, Molecular Focused
Eurofins BioPharma Product Testing Ireland, Ltd., Denver, Colorado, United States
Full-time
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. 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. Meet basic expectations of DPT’s quality management system, including good workmanship, adherence to standard operational procedures, training, good documentation practices, and accurate recordkeeping. Responsible for the development and execution of the laboratory structure and organization at each site. Oversee the overall operation and administration of the laboratory in accordance with CLIA regulations. Maintain continuous lab operations with integrity and validity for all laboratory activities. Provide oversight of the Microbiology laboratory leadership team to ensure timely delivery of quality test results. 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 laboratory operation. Develops, implements & enforces laboratory policies, procedures & performance standards. Work with the Director of Laboratory Operations to plan, develop, and drive the vision and strategy of the laboratory. Participate in developing new methodologies & tests and strategic planning initiatives. Oversee all laboratory testing and provide scientific expertise to staff for all human-related specimens. Report critical information to the Executive Team as needed. Demonstrate passion and enthusiasm for the company's vision, and motivate, lead, and empower others to achieve company goals. Evaluate automation of current and new testing platforms based on department needs. 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 to evaluate laboratory efficiency and effectiveness. Ensure timely review and approval of all laboratory procedure and safety manuals. Ensure an annual review of training and competency files and corrective action plans/reports. Continuous staffing model assessment and oversight of headcount for the Microbiology department. Ensure prompt corrective action for all lab audit findings or deficiencies noted. Serve as a laboratory departmental liaison during regulatory inspections and/or client audits. Maintain suitable staffing levels throughout the lab and satellite locations; provide continuous feedback and training. Ensure the laboratory meets all audits and maintains appropriate regulatory status. Stay updated on regulatory requirements for the industries serviced (i.e. CLIA, FDA, TGA, etc.). Plan, direct and manage the Sterility and Microbiology Laboratory in all activities related to Microbiology testing. Implement policies and procedures that will improve day-to-day operations. Possess excellent presentation skills and exceptional cross-functional team leadership skills. Demonstrate strong organizational and planning skills with attention to detail. Problem-solve and make decisions on complex issues 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. Handle discipline and termination of employees as needed in accordance with company policy. Conduct timely and constructive performance evaluations. Create and execute on department strategy with support of Director of Laboratory Operations. Participate in the hiring and training of managers, supervisors and leads. Communicate and explain new directives, policies, or procedures to managers. Qualifications
MINIMUM REQUIREMENTS Must have an M.D., Ph.D., or M.D. / Ph.D., and be fellowship trained (ABP MM or ASM CPEP) and board-certified or board-eligible in Medical Microbiology. Must meet the Code of Federal Regulations 493.144: (1) 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 certified in anatomic or clinical pathology, or both, by the American Board of Pathology or the American Osteopathic Board of Pathology; OR (2) 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 (3) Hold an earned doctoral degree in a chemical, physical, biological, or clinical laboratory science from an accredited institution and be certified by a board approved by HHS; OR (4) 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; OR (5) 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. WORK EXPERIENCE REQUIREMENTS Experience in the clinical laboratory setting with a strong focus on Microbiology identification methods. 4-5 years of experience serving as a director of a Clinical Microbiology Laboratory is preferred. Excellent communication and interpersonal skills. 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. Proven success in training and developing technical employees. Ability to problem solve and provide solutions under minimal supervision. 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. Additional Information
Compensation: Schedule: Monday-Friday 8:00am-4:30pm 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 is an M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.
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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. 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. Meet basic expectations of DPT’s quality management system, including good workmanship, adherence to standard operational procedures, training, good documentation practices, and accurate recordkeeping. Responsible for the development and execution of the laboratory structure and organization at each site. Oversee the overall operation and administration of the laboratory in accordance with CLIA regulations. Maintain continuous lab operations with integrity and validity for all laboratory activities. Provide oversight of the Microbiology laboratory leadership team to ensure timely delivery of quality test results. 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 laboratory operation. Develops, implements & enforces laboratory policies, procedures & performance standards. Work with the Director of Laboratory Operations to plan, develop, and drive the vision and strategy of the laboratory. Participate in developing new methodologies & tests and strategic planning initiatives. Oversee all laboratory testing and provide scientific expertise to staff for all human-related specimens. Report critical information to the Executive Team as needed. Demonstrate passion and enthusiasm for the company's vision, and motivate, lead, and empower others to achieve company goals. Evaluate automation of current and new testing platforms based on department needs. 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 to evaluate laboratory efficiency and effectiveness. Ensure timely review and approval of all laboratory procedure and safety manuals. Ensure an annual review of training and competency files and corrective action plans/reports. Continuous staffing model assessment and oversight of headcount for the Microbiology department. Ensure prompt corrective action for all lab audit findings or deficiencies noted. Serve as a laboratory departmental liaison during regulatory inspections and/or client audits. Maintain suitable staffing levels throughout the lab and satellite locations; provide continuous feedback and training. Ensure the laboratory meets all audits and maintains appropriate regulatory status. Stay updated on regulatory requirements for the industries serviced (i.e. CLIA, FDA, TGA, etc.). Plan, direct and manage the Sterility and Microbiology Laboratory in all activities related to Microbiology testing. Implement policies and procedures that will improve day-to-day operations. Possess excellent presentation skills and exceptional cross-functional team leadership skills. Demonstrate strong organizational and planning skills with attention to detail. Problem-solve and make decisions on complex issues 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. Handle discipline and termination of employees as needed in accordance with company policy. Conduct timely and constructive performance evaluations. Create and execute on department strategy with support of Director of Laboratory Operations. Participate in the hiring and training of managers, supervisors and leads. Communicate and explain new directives, policies, or procedures to managers. Qualifications
MINIMUM REQUIREMENTS Must have an M.D., Ph.D., or M.D. / Ph.D., and be fellowship trained (ABP MM or ASM CPEP) and board-certified or board-eligible in Medical Microbiology. Must meet the Code of Federal Regulations 493.144: (1) 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 certified in anatomic or clinical pathology, or both, by the American Board of Pathology or the American Osteopathic Board of Pathology; OR (2) 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 (3) Hold an earned doctoral degree in a chemical, physical, biological, or clinical laboratory science from an accredited institution and be certified by a board approved by HHS; OR (4) 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; OR (5) 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. WORK EXPERIENCE REQUIREMENTS Experience in the clinical laboratory setting with a strong focus on Microbiology identification methods. 4-5 years of experience serving as a director of a Clinical Microbiology Laboratory is preferred. Excellent communication and interpersonal skills. 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. Proven success in training and developing technical employees. Ability to problem solve and provide solutions under minimal supervision. 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. Additional Information
Compensation: Schedule: Monday-Friday 8:00am-4:30pm 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 is an M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.
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