Director, Laboratory Operations

Director, Laboratory Operations / Administrative Director

Location: Office-based, Farmingdale, NY

Who We Are:

ICON Central Laboratories are dedicated exclusively to central laboratory testing and the associated services for life-saving clinical trials. Our Central Labs perform safety / core lab testing, Immunology, Molecular, Micro, Flow Cytometry and Pathology testing for patients. We are a global CAP accredited laboratory adhering to NYS regulations in our Farmingdale facility.

Position Summary:

This role is extremely similar to an Administrative Director in a hospital laboratory, with the added responsibility of oversight for budget, metrics and quality management. This individual will have responsibility for the entire testing laboratory and will work cross-functionally to support the wider global labs and ensure high quality services for our clients.

Position Duties:

• Recognize, exemplify and adhere to ICON's values which center around our commitment to People, Clients and Performance.
• As a manager, the employee is expected to recognize the importance of and create a culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.
• Travel (approximately 5%) domestic and/or international.
• Responsible for Oversight of the laboratory department's operational activities within quality and budgetary guidelines, including oversight of continuous improvements and operational updates.
• Responsible-for high-level management of all Proficiency Testing programs, within the- guidelines of regulatory requirements and pertinent SOP's.
• Provides oversight for and guides the development, implementation and management of performance standards for staff related to quality and efficiency, including productivity.
• Ensures the laboratory management team adheres to written internal and external quality control procedures in order to maintain the quality of results.
• Guides the evaluation of means and standard deviations for quality control materials and ensures the maintenance of corrective action logs as appropriate.
• Responsible for oversight of the quality and timelines of technical procedures to ensure full compliance with CAP requirements, relevant government regulations, GDP and other relevant standards as determined by the company.
• Builds strong and effective teams, valuing different contributions; works with and through others, involving people in issues that affect them.
• Oversee the recruitment and selection of staff.
• Operates independently with a willingness to make decisions; Projects credibility and makes a professional and positive impression on others.
• Liaise with clients, vendors and ILS or other ICON staff on all department issues.
• Maintains oversight of reagent and supply orders and approval of inventory purchases.
• Working with the corporate procurement team, negotiates pricing and service requirements with Vendor representatives, supporting the best interests of ICON.
• Ensures that the laboratory management team monitors reagents and supplies for section and assists in the performance of all related tasks for managing inventory.
• Identifies the key elements of a situation and any gaps and inconsistencies in data.
• Makes rational judgements from available information and analysis.
• Actively participates in root cause analysis investigations and process improvement initiatives.
• Responsible for timely and accurate responses to Quality Issues assigned to them and/or their department.
• Identifies development opportunities for self and others; Acts as a coach and mentor and shares expertise.
• Maintains a positive working environment ensuring staff motivation and engagement.
• Maintains low levels of staff turnover, actively contributing to the retention of key individuals.
• Manages the evaluation of and validation of new methodoloqies and instrumentation.
• Works closely with Global Validations Department.
• Liaison with other ICON departments/divisions in order to facilitate global implementation of laboratory process and or procedure
• Maintains, supports, and/or develops improved customer relations through direct interaction on items of laboratory significance. Also Interacts with clients and internal/external auditors.
• Reviews SOP content and provides feedback to authors as necessary to ensure compliance with regulatory requirements.
• Provides oversight for all educational, training and regulatory requirements for technical staff. Ensures management team monitors technical staff for compliance.
• Is aware of all pertinent employee health and safety regulations and requirements for their department and manages compliance to same.
• Manages all relevant projects in accordance with established timelines, budget, quality standards and/or contractual requirements.
• Approves purchase orders and all appropriate purchases for managed departments.
• Covers for the Director and/or VP Laboratory Operations in the event of his or-her absence.
• Any other relevant tasks as assigned by management.

Requirements:

• Hold a New York State License as a Clinical Laboratory Technologist, OR
• Hold an earned Doctoral Degree in a Chemical, Physical, Biological or Clinical Laboratory Science from an accredited institution and be certified and continue to be certified by a board approved by HHS (This includes ABCC & ACHI)
• Minimum 10+ years of experience in clinical laboratory with at least 6+ of those in operational management
• Significant proven experience of all local/regional/national health and safety requirements and awareness of employee responsibilities in this context. Basic knowledge of immunization requirements for the role of occupational health professions.
• Proficient in all CAP and local regulatory agency requirements.
• Excellent knowledge of Microsoft Office.
• Fluency in English both written and oral.
• Significant proven experience managing multiple tasks with good organization skills and good attention to detail. Ability to work as part of, and set the example of performance standards for a team.
• Ability to lead a team to work in conformance with standard operating procedure and conditions with a systematic approach to tasks committed to seeing things through to completion.
• Demonstrated ability to keep accurate, legible records and recognize the need to handle these records and all other information in line with GCP/GDP.
• Familiar with the operation of laboratory equipment with a demonstrated ability to check that equipment is functioning within its specifications and to respond appropriately to abnormalities.
• Demonstrates the ability to understand the principles of quality control, quality assurance. Knowledge of the role of audit and review in quality management, including quality control, quality assurance and the use of appropriate outcome measures.
• Demonstrates patience and knowledge of laboratory operations to act as a mentor to section team, identifying and developing each person's unique talent with a view to achieving department/company objectives.
• Customer Focused -providing timely, confident, reliable and friendly service to all our internal and external customers and inspiring the team to follow your example.
• Demonstrates a high level of personal integrity and ethical behavior with a responsible and mature approach to work duties. A willingness to lead from the front and inspire by example.
• Action oriented demonstrating the ability to handle work load demands resulting in the generation of large amounts of data and to trouble shoot issues timely when required.

ICON is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.