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Clinical Lab Manager

Bryn Athyn, PA 19009

Posted: 09/19/2023 Employment Type: Direct Hire/Perm Job Category: Scientific Job Number: 581145 Is job remote?: No Country: United States

Job Description


The Clinical Laboratory Manager has primary responsibility for the oversight and management (administrative and technical) of the daily operations of the US Clinical Laboratory that conducts testing of clinical samples, using manual and automated methods in a team environment, and following established policies and procedures, in a professional manner.   
Reporting to the VP of Operations & Site Manager, the Clinical Lab Manager ensures department objectives are aligned with CLIA standards and assists in the establishment of lab workflow and priorities. 

Essential Functions •    Oversee the daily technical and non-technical operational activities of the US Clinical Lab, which includes NGS and molecular activities.
•    Effectively manage the staffing of the department (internal employees and external contractors) and monitor the operating schedule(s) to ensure adequate coverage and proper use of external resources; adjust as needed. 
•    Interpret sequencing quality data, and results.
•    Assist the Functional Head with effectively managing change, facilitating innovation and fostering teambuilding to provide the highest quality and most cost effective laboratory product(s) possible. 
•    Resolves operational issues in a timely manner by consulting with the Functional Head, Medical Director, QA, R&D and Industrial Operations/Production laboratories. 
•    In collaboration with the US Customer Experience & Support Manager for the Clinical Lab, resolves client enquiries.
•    Ensures laboratory is compliant with corporate, state and federal regulatory requirements related to personnel safety and quality of laboratory testing as well as professional conduct in assigned areas. 
•    Assist with developing and implementing of laboratory procedures as well as installation of equipment and methods according to scheduled timelines. 
•    Ensures effective communication with internal and external partners. 
•    Ensure personnel competency and address performance related issues as necessary. 
•    Assist sales and scientific support staff with the development of clinical trial partnerships and initiation of clinical lab services. 
•    Manage data appropriately and according to established guidelines, including the creation of customer data reports in the LIMS system. 
•    Assist the Functional Head and the QA department with audit preparation and successful execution (assist in GAP assessments, re-certifications, and audit documentation for CAP/ CLIA/ NYS/ CA and ISO 15189). 
•    Manage and oversee the Company Phlebotomy Program.
Other Duties 
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

General Competencies  •    Strong Clinical Laboratory technical and leadership acumen 
•    Communication proficiency 
•    Organizational skills 
•    Customer-centricity 
•    Initiative and drive 

Education and Experience •    MS or BS degree in Molecular Biology, Biotechnology, Biology, or Medical Technology. 
•    10+ years or laboratory experience with a strong base in technical knowledge of concepts, principles, practices, methodologies and instrumentation of each discipline of laboratory science and technology in performing complex analytical analysis. 
•    5+ years of supervisory experience in a high complexity laboratory setting. 
•    Good organizational and complex problem-solving skills. 
•    Dependability with a strong work ethic, initiative, flexibility and innovative thinking. 
•    Accuracy with exceptional attention to detail with the ability to look at the broader picture. 
•    Knowledgeable of quality control principles sufficient to maintain and advise on actions taken relative to quality control and correlation of laboratory results. 
•    Ability to institute continuous quality improvement principles to produce the best possible laboratory data. 
•    Prior experience in a leadership position for CLIA and/or CAP inspections, audits, and laboratory compliance. 
•    Ability to collaborate cross-functionally and communicate well with other departments. 
•    Prior experience in clinical NGS and molecular operations is a plus.

Work Environment 
This job operates in a professional office and CLIA laboratory setting. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines; scientific laboratory equipment, and any/all required PPE. 

Physical Demands 
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. 
This role can be sedentary at times. However, some filing is required. This would require the ability to lift files, open filing cabinets and bend or stand as necessary. 

Position Type/Expected Hours of Work 
This is a full time, exempt, professional-level position. Typical days and hours of work are Monday through Friday, 8:00 a.m. to 5:00 p.m.; however, this position may require longer hours, evening, and weekend work as necessary. 

This position may require infrequent domestic or international travel; approximately 5% or less. 

Salary Range: $100-$130k. Salary will be commensurate with experience. 
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