Clinical Laboratory Supervisor

AIM OF THE POSITION

This position is responsible for supervising operations in various areas of the laboratory, which may include diagnostic testing, clinical studies, validation studies, logistics, and quality activities. This position interacts with internal and external customers to provide the highest levels of service and supports all departments in accomplishing Agendia's mission to improve the quality of life for cancer patients through molecular diagnostics, one patient at a time.

POSITION WITHIN THE ORGANIZATION

Reports to Manager, Laboratory Operations ? Director, Global Operations ? Sr. VP, Global Operations ? Chief Operating Officer

ESSENTIAL DUTIES AND RESPONSIBILITIES

Lead and Supervision

* Provide leadership and guidance to a team of Clinical Laboratory Scientists and Technicians specialized in molecular testing.

* Develop and maintain a positive and collaborative work environment that promotes teamwork, productivity, and continuous learning.

* Provide feedback and identify opportunities for professional growth and development.

* Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include:

o Participating in interviewing, hiring, and training employees

o Planning, assigning, and directing work

o Participating in performance appraisal

o Addressing complaints and resolving problems

Laboratory Operations

* Perform high complexity molecular testing in accordance with Agendia's standard operating procedures.

* Ensure adherence to laboratory protocols, safety guidelines, and regulatory standards throughout all molecular testing processes.

* Monitor and maintain the laboratory's quality management system, including proficiency testing, equipment maintenance, and calibration.

* Coordinate work schedules, manage workload distribution, and ensure adequate staffing to meet operational needs.

Data Analysis and Reporting

* Analyze and interpret molecular testing results, troubleshoot anomalies, and verify the accuracy and validity of data.

* Prepare comprehensive reports summarizing assay performance, quality control metrics, and any deviations encountered during testing.

* Collaborate with the laboratory director, physicians, and other healthcare professionals to ensure accurate and timely reporting of test results.

Quality Control

* Develop and maintain documentation, standard operating procedures (SOPs), and quality control measures related to molecular testing.

* Monitor and evaluate quality control data, troubleshoot issues, and implement corrective actions as necessary.

Compliance and Regulatory

* Ensures compliance with regulatory and accrediting agencies such as CAP, CLIA, ISO and FDA.

* Participates in inspections and audits as needed.

Compliance and Regulatory

* Initiate own career development by being familiar with current literature, seeking out seminars, workshops and other professional meetings relating to professional field.

* Exhibit ethical and professional behavior at all times

* Maintain patient confidentiality at all times

KEY CONTACTS

Internal: Interacts with multiple departments including Laboratory Operations, R&D, Medical Affairs, QA/RA, IT, and Commercial

External: Participates in meetings and interactions with vendors, customers, collaborators, regulatory agencies, and members of the scientific community

EDUCATION AND EXPERIENCE REQUIREMENTS

Education

* Minimum Bachelor's degree in chemical, physical, biological, or clinical laboratory science or medical technology from an accredited institution

* CA CLS License required

Experience

* 6+ years relevant laboratory experience in biology or genetics with a large component of hands-on high-complexity testing

* 2+ years in a lead laboratory role

* Experience in or significant exposure to Validation and/or QA/QC in a regulated scientific industry (e.g., medical testing, CLIA or GLP laboratory, GMP manufacturing), and familiarity with key concepts of operating under a Quality System

* Demonstrated experience in leading teams

KNOWLEDGE, SKILLS AND ABILITIES (KSA'S)

In-depth Knowledge

* Strong knowledge and understanding of molecular biology principles, techniques, and methodologies.

* Thorough understanding of molecular diagnostic testing platforms, including PCR, DNA sequencing, and Next-Generation Sequencing (NGS).

* Proficient knowledge of regulatory requirements and guidelines governing molecular testing, such as CLIA, CAP, and NYSDOH.

Quality Control and Quality Assurance

* Comprehensive understanding of quality control principles and practices in molecular testing.

* Proficiency in establishing and implementing quality control measures to ensure reliable and accurate test results.

* Ability to identify and troubleshoot issues related to quality control and implement appropriate corrective actions.

Laboratory Operations

* Thorough knowledge of laboratory operations, workflow management, and laboratory safety protocols.

* Proficiency in maintaining and calibrating laboratory instruments and equipment used in molecular testing.

* Familiarity with laboratory information systems (LIS) and proficiency in using laboratory automation software.

Data Analysis and Interpretation

* Strong analytical skills to analyze and interpret molecular testing results, identify trends, and troubleshoot anomalies.

* Ability to generate comprehensive reports summarizing assay performance and test results accurately and concisely.

Leadership and Communication

* Exceptional leadership and team management skills to effectively lead a team of Clinical Laboratory Scientists and Technicians.

* Excellent interpersonal and communication skills, both written and verbal, to collaborate with cross-functional teams and present findings to stakeholders.

* Ability to provide clear instructions, guidance, and feedback to team members to ensure high-quality performance.

Adaptability and Problem-Solving

* Ability to adapt to changing laboratory technologies, techniques, and regulatory requirements.

* Strong problem-solving skills to identify and resolve complex issues related to assay development, validation, and troubleshooting.

* Capacity to work independently and make informed decisions while considering the impact on patient care and laboratory operations.

BEHAVIOURAL COMPETENCIES/DESIRED SKILLS

Leadership

* Ability to inspire and motivate a team, foster a positive work environment, and effectively lead and manage a group of Clinical Laboratory Scientists and Technicians specialized in molecular testing.

* Demonstrates strong decision-making skills and the ability to resolve conflicts and address performance issues in a constructive manner.

Collaboration

* Actively seeks input, shares information, and encourages open communication to achieve common goals.

Attention to Detail

* Displays meticulous attention to detail and accuracy in all aspects of work, including quality control, documentation, and data analysis.

* Recognizes the importance of precision in molecular testing and maintains high standards of quality assurance.

Adaptability

* Demonstrates flexibility and adaptability in a fast-paced laboratory environment.

* Effectively manages multiple priorities, changes in project scope, and shifting timelines while maintaining a high level of productivity and quality.

Problem-Solving:

* Exhibits strong analytical and problem-solving skills to identify and address complex issues related to assay development, validation, troubleshooting, and quality control.

* Proactively seeks innovative solutions and implements appropriate corrective actions to ensure accurate and reliable molecular testing results.

Communication:

* Possesses excellent written and verbal communication skills to effectively convey information and instructions to team members, stakeholders, and external parties.

* Listens actively, asks clarifying questions, and presents findings clearly and concisely

Continuous Learning:

* Demonstrates a commitment to ongoing professional development and staying current with advancements in molecular biology and molecular testing methodologies.

* Actively seeks opportunities for learning, engages in self-directed learning, and shares knowledge and expertise with the team.

Ethical Conduct

* Upholds the highest ethical standards and adheres to regulatory guidelines and best practices in the field of molecular testing.

* Demonstrates integrity, professionalism, and a commitment to patient safety and confidentiality.

WORKING ENVIRONMENT

Laboratory Setting

* Technical work will take place in a well-equipped and modern laboratory facility.

* The laboratory will be equipped with specialized instruments and equipment for molecular testing, and safety protocols will be strictly followed to ensure a secure and controlled work environment.

Schedule

* The position requires working on a full-time basis, typically during regular business hours. However, there may be instances where the role requires flexibility in working hours to accommodate the needs of the laboratory, such as occasional evening, night, or weekend shifts, particularly in urgent or time-sensitive situations.

Fast-Paced and Time-Sensitive

* Molecular testing operates within tight timelines and with high demand.

* Comfortable working in a fast-paced environment, managing multiple priorities, and meeting deadlines while maintaining attention to detail and quality standards.

* PRIVACY NOTICE: To review the California privacy notice, click here: https://agendia.com/privacy-policy/

* Employees must not be classified as an excluded individual who is prohibited from participation in any Federal health care program.

ENVIRONMENT/SAFETY/WORK CONDITIONS

Physical Demands

* The position may involve prolonged periods of standing or sitting while performing laboratory tasks, including sample preparation, instrument operation, and data analysis.

* May require the ability to lift and carry laboratory equipment and supplies up to 15 pounds.

* Walking, bending, reaching, and repeated fine manual manipulation.

* All candidates must undergo a color vision test.

Occupational Hazards

* As with any laboratory setting, there may be occupational hazards associated with the handling of biological samples, hazardous chemicals, and potentially infectious materials.

* In adherence to strict safety protocols, use of appropriate personal protective equipment (PPE) including face shields, lab coats, and masks, is required.

TRAVEL

* Up to 5% international and domestic travel as required or assigned

OTHER DUTIES

The above listing represents the general duties considered essential functions of the job and is not to be considered a detailed description of all the work requirements that may be inherent in the position. Other duties may be assigned or required.