Laboratory Director, Central Lab Services

 Position Summary:

The Laboratory Director, Central Lab Services is responsible for overseeing and coordinating the daily operations and long-term development of commercial operations at a designated Precision for Medicine central laboratory. This role will manage the Biorepository located in Frederick, Maryland.  Oversight will include Manager, Supervisors, Team Leads and support staff to ensure the successful implementation and execution of new/ongoing commercial projects while maintaining adherence to global standard operating procedures and quality control guidelines. Extended work hours may be necessary in order to meet business demands.

Essential functions of the job include but are not limited to:

Laboratory Management: 

• Provide direct oversight to Biorepository, site-specific data management personnel. Successfully train assigned Biorepository staff members in proper operation of all protocols, appropriate equipment usage and specimen handling. Oversight of all Biorepository activities including receipt, accessioning, storage, retrieval and shipment of client samples.
• Manage all resources in an efficient manner, collaborating with other departments if required, to ensure successful execution of client work orders while retaining adherence to all standard operating procedures.
• Facilitate Accessioning/storage of all incoming client samples in accordance with each project’s signed statement of work as dictated by project operating procedures.
• Ensure maintenance of client sample integrity and data accuracy through adherence to quality control procedures and guidelines.
• Enforce accurate and timely utilization of the specimen management inventory system/s for documentation of work performed.
• Enforce GMP/GLP/ISO/CAP/CLIA regulations and standards as applies to assigned laboratory operations.
• Maintain and implement good laboratory/Biorepository practices to ensure compliance with governing safety standards.
• Collate and analyze operational metrics related to department budgets and schedules for use in monitoring and controlling project performance and for use in projecting future project trends related to cost, completion time and resource needs.
• Participate in preparation of proposed annual budget for the Frederick Biorepository.

Global Harmonization

• Collaborate with leadership teams at other Precision for Medicine central laboratory Biorepository sample mangement to ensure cross-site harmonization in operating procedures, develop and share solutions to issues encountered, and facilitate inter lab sample transfers and project management.
• Provide oversight and leadership of the Frederick, MD Biorepository to ensure consistent procedures, practices, and quality for client programs.

Communications & Reporting: 

• Assist clients and collaborators in the design and implementation of new studies by developing logistical plans that optimize quality and efficiency in the areas of Biorepository sample management and transport.
• Communicate with clients and collaborators regarding Biorepository sample management, inventory control, shipping procedures as associated data management for laboratory operations.
• Prepare detailed reports and correspondence regarding ongoing/historical work to clients and collaborators, and department director as required.
• Resolve complex issues that may arise in the daily operations of assigned project(s) and assist in resolution of issues that may arise in other areas of our organization. Communicate resolutions in a professional and logical manner.

Employee Development:

• Ensure successful onboarding and training of staff members on applicable duties; ensure that all documentation of training is accessible and up to date for all staff members (including oneself). Training will be performed in accordance with global guidelines to ensure cross-site consistency in operator knowledge and skillsets.
• Supervise and manage staff in keeping with expressed objectives and corporate culture, and in doing so provide a workplace where ideas are sought and considered, initiative is encouraged, success is rewarded, and employees are treated fairly, with respect and recognition.
• Conduct regular one-on-one meetings with direct reports, as needed. Share and document information promptly with manager and Human Resources as appropriate.
• As a member of management, lead through example as well as require adherence to policy, procedures and professional standards at all times, including interactions of direct reports outside of work and on-line.
• Professionally and positively represent the Company by endorsing and supporting company decisions to influence staff "buy in" without conflict.
• Be activ