Associate Laboratory Director

Thornton Tomasetti; Madison (WI); On-site; USD 113,000 - 227,000; Full time

Benefits offered by this job

HIP PPO coverage

Retirement plan

Tuition reimbursement

Freedom 2 Save program

FreeU education

Job summary

Abbott seeks an Associate Laboratory Director to ensure medical and technical performance of delegated tests, act as a subject matter expert, and uphold regulatory and quality standards. You will guide cross-functional teams across Laboratory Operations, Quality, IT, and product development, ensuring staff competency and robust incident management.

The role requires onsite presence, strong leadership, and deep knowledge of molecular testing, with engagement across analytic, pre-analytic, and

Qualifications

• MD or DO with a current medical license & board certification in Anatomic and/or Clinical Pathology or equivalentQualifications
• Doctoral degree in chemical, physical, biological or clinical laboratory sciences with board certification or equivalent training
• Experience leading teams, projects, or committees with leadership through influence
• Strong understanding of molecular testing and techniques; analytical, risk management, and communication skills

Responsibilities

• Ensure delegated tests meet medical and regulatory standards
• Support training and competency programs for staff
• Collaborate with R&D, product and software teams on performance requirements
• Oversee validation/verification procedures for test accuracy and precision
• Maintain Quality Management System and incident investigation processes
• Communicate clearly with cross-functional teams and stakeholders

Skills

Medical license

Board certified

Laboratory leadership

Molecular testing

Analytical thinking

Communication skills

Risk management

Onsite work

Education

MD/DO (medical license)

Doctoral degree in one of the sciences

Laboratory certification

Job description

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 122,000 colleagues serve people in more than 160 countries.

JOB DESCRIPTION: Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You’ll also have access to: Career development with an international company where you can grow the career you dream of. Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year. An excellent retirement savings plan with a high employer contribution. Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree. A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune. A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists.

Position Overview

The Associate Laboratory Director is responsible for ensuring the medical and technical performance of tests delegated by the laboratory director, as well as serving as a subject matter expert (42 CFR 493.1451). These responsibilities include, but are not limited to, ensuring delegated tests meet medical, professional and regulatory performance standards, providing medical expertise in the assessment of patient materials, supporting physicians regarding patient results and laboratory processes, ensuring qualified, well-trained and competent staff, and ensuring effective investigation and resolution to incidents. The Associate Laboratory Director will participate in the Quality Management System, ensuring personnel, test performance/design, test procedures, equipment and facilities support the highest possible medical and operational quality. The Associate Laboratory Director will work closely with cross-functional team members including Laboratory Operations (pre-analytic, analytic and post-analytic), Laboratory Medical and Pathology, Customer Service, Product/commercial, Quality, Systems Engineering, Information Technology, and Facilities in the improvement and development of new processes and technologies.

Essential Duties

• Support the clinical laboratory director to ensure effective functioning of all tests
• Effective communication regarding all delegated activities
• Ensure test performance requirements are established that meet regulatory and medical performance standards
• Ensure appropriate test performance characteristics are defined
• Ensure medical and technical performance characteristics are evaluated against current regulatory and medical standards and best practices
• Ensure that the testing systems developed and used for each test performed in the laboratory meet or exceed established test performance requirements, to include the pre-analytic, analytic, and post-analytic phases of testing
• Ensure that test methodologies have the capability of providing the quality of results required for patient care
• Liase with (or delegate appropriately) R&D, product and software teams to provide performance requirements, validation design and requirements that meet regulatory and medical best practices and standards
• Ensure validation and verification procedures are adequate to determine the accuracy, precision, and other pertinent performance characteristics established for the test
• Ensure laboratory personnel are performing the test methods as required for accurate and reliable results
• Ensure training and competency programs are appropriate
• Ensure that the laboratory has an appropriate proficiency testing program
• Collaborate with the quality team to ensure effective quality control and assurance programs are established and maintained, including policies and procedures and mechanisms to:
• Ensure the establishment, monitoring, and review of acceptable levels of analytical performance for each test system
• Ensure that patient test results are reported only when the test system is functioning properly, and that remedial actions are taken and documented whenever significant deviations from established performance are identified
• Ensure that test result reports include pertinent information required for interpretation
• Support and ensure incident investigation, corrective and preventive action
• Collaborate with cross-functional partners on efforts during new product commercial launches, such as training, documenting standard operating procedures (SOPs), reviewing marketing materials, etc.
• Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork
• Support and comply with the company’s Quality Management System policies and procedures
• Maintain regular and reliable attendance
• Ability to act with an inclusion mindset and model these behaviors for the organization

Minimum Skills and Qualifications

Ability to meet one of the qualifications below: MD or DO with a current medical license & board certification in Anatomic and/or Clinical Pathology or possess equivalent qualifications as those required for certification OR MD, DO or DPM with a current medical license and laboratory training/experience consisting of the following: 1 yr laboratory training high complexity testing OR Doctoral degree in chemical, physical, biological or clinical laboratory sciences with certification by a board approved by HHS OR Doctoral Degree in relevant science plus 1 year training OR Experience leading teams, projects, and/or committees with a demonstrated ability to lead through influence. Strong understanding of molecular testing and techniques Excellent analytical, critical thinking and risk management skills Excellent communication skills Be onsite at least 4 days/week Apply excellent written and verbal communication skills to convey difficult information in a clear, kind, and respectful manner. Ability to comply with any applicable personal protective equipment requirements. Ability to use near vision to view samples at close range. Ability to travel 5% of working time away from work location, may include overnight/weekend travel. Ability to lift up to 15 pounds for approximately 5% of a typical working day. Ability to work on a mobile device, tablet, or in front of a computer screen and/or perform typing for approximately 80% of a typical working day. Ability to work in and contribute to a fast-paced, highly collaborative environment. Demonstrated ability to perform the Essential Duties of the position with or without accommodation. Authorization to work in the United States without sponsorship.

Preferred Qualifications

ABMGG certification Ability to hold NY CoQ in molecular genetics

Job Details

• The base pay for this position is $113,300.00 – $226,700.00 In specific locations, the pay range may vary from the range posted.
• JOB FAMILY: Research and Discovery
• DIVISION: ONCO Cancer Diagnostics
• LOCATION: United States > Madison : 1 Exact Lane
• ADDITIONAL LOCATIONS: WORK SHIFT: Standard TRAVEL: Yes, 5 % of the Time MEDICAL SURVEILLANCE: No SIGNIFICANT WORK ACTIVITIES: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)

EEO

Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans. EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf

About Abbott

Abbott is about the power of health. For more than 135 years, Abbott has been helping people reach their potential — because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 160 countries, we create new solutions — across the spectrum of health, around the world, for all stages of life. Whether it’s next‑generation diagnostics, life‑changing devices, science‑based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health. The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well-being of millions of people. They push the boundaries to help manage and treat some of life’s greatest health challenges. We invite you to explore opportunities at Abbott, to see if your talents and career aspirations may fit with our openings. An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.

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