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Position Overview
The Histology Manager is responsible for the operation of Exact Sciences Histology Laboratory, including leadership of the designated laboratory team. This operational leader will continually build the Histology team’s capabilities as it takes on new products, new laboratory information management systems, new laboratory processes, and rapidly increasing sample volumes. He or she will collaborate with various departments and cross-functional teams to ensure the quality and timeliness with which patient and study samples are processed and will have accountability for the Histology team’s deliverables on a wide range of product development and process development projects as assigned. The Histology Manager will facilitate timely and effective communication with Customer Service, Pathology, the Analytical Laboratory, and within the Histology team regarding service coverage needs and resolution of issues related to commercial patient samples, adjusting laboratory staffing levels as needed. The Histology Manager is responsible for the compliance of the Histology Laboratory with all regulatory requirements and Exact Sciences policies and procedures, as well as documentation and monitoring of quality and performance metrics as assigned, and the implementation of process and quality improvement initiatives as assigned.
The high volume, stringent quality requirements, and interactive nature of the work requires excellent attention to detail, effective written and verbal communication skills, and commitment to developing and motivating employees. The Manager must be able to work both independently and collaboratively in a team environment, fostering excellent communication and teamwork within the Histology team and with other functional areas.
The Histology Manager will act as a liaison between the Histology Laboratory and various functional groups including but not limited to Customer Service, Pathology, Analytical Laboratory, Biomaterials Repository, Quality, Service Engineering, Process Engineering, Information Technology, Reagent Quality, Biostatistics, Supply Chain Management and Facilities groups for the designated operation’s team or projects. Anticipating changes driven by business growth, the Histology Manager may develop plans for the required staffing, equipment and space for the assigned projects or initiatives. He or she will also contribute to management of our growing business by gathering and analyzing Histology production costs, assisting in the budget process as assigned, troubleshooting technical and non-technical problems, coaching and mentoring laboratory staff, building effective teams, managing assigned projects and taking accountability for the Histology team’s operational deliverables. This position will have responsibility for hiring, managing, developing and motivating Histology staff, including the management team. The Histology Manager will prepare the Histology Laboratory for internal and external inspections, ensure ongoing readiness and represent the Histology Laboratory during the inspections as assigned. The Histology Manager will be involved in scheduling and direct supervision of daily laboratory processes.
Given the wide variety of responsibilities for this position, the Histology Manager must demonstrate outstanding leadership, operational management, and organizational skills. He or she must have the ability to analyze complex issues and make sound decisions in a timely manner, the ability to remain professional and composed under pressure, and the ability to respond to difficult issues quickly, fairly, and ethically. The Histology Manager must be able to utilize various communication channels effectively and proactively communicate team goals and priorities clearly, openly and objectively, and communicate changes, issues, and challenges in all directions of the organization.
Essential Duties
Include, but are not limited to, the following:
- Oversee the operations of the Histology laboratory including but not limited to ensuring processing systems for patient and study samples are functioning properly, consistently achieving turnaround time targets, monitoring quality control testing results, monitoring quality assurance performance metrics as assigned, planning, validation and implementation of new test procedures as assigned, and leadership and supervision of Histology Laboratory personnel.
- Maintain stringent standards for quality, identifying any issues which might adversely impact the quality of test results and/or employee safety, and immediately communicating these to the appropriate management representatives as necessary for prompt resolution.
- Work with the Histology Laboratory management team and staff, Pathology, Quality and other functional areas on the laboratory’s quality control and quality assurance procedures, technical/process troubleshooting and improvement procedures, and staff training and education programs.
- Engage with Histology leadership team for continuous improvement of team leadership practices including department communication methods, hiring and staff assessment, performance and compensation recommendations, teambuilding and preservation and enhancement of Exact Sciences’ unique culture.
- Collaborate with Pathology, Customer Service, Analytical Laboratory, Biomaterials Repository, Information Technology, Process and Service Engineering, and other functional areas and cross functional teams to address process and workflow issues.
- Manage laboratory and cross-functional projects such as process improvements, quality improvements, and the development and launch of new products as assigned.
- Write and review standard operating procedures, nonconformance and deviation approval requests, and other documents as appropriate.
- Manage performance of the Histology team, writing, reviewing and conducting staff performance assessments.
- Oversee the training and competency assessment of the Histology personnel as assigned.
- Manage laboratory resources, conduct cost analysis as assigned, assist in annual budgeting process, and explore various improvement initiatives.
- Hold staff meetings; initiate staff development plans and activities to foster team building.
- Ensure consistent compliance with all federal, state, and local regulatory requirements and with all company policies and procedures.
- Oversee the inspection preparation activities in the Histology Laboratory; maintain consistent, ongoing readiness for inspections and represent Histology during inspections as assigned.
- Consistent demonstration of exceptional leadership qualities, including but not limited to the ability to attract and retain the best team, foster a culture of high performance, lead with integrity, humility, accountability, and courage, and set a clear vision to energize teams towards the future.
- Effectively manage, support, and guide your team, including, but not limited to delegating tasks and responsibilities, assess employee performance and provide helpful feedback and training opportunities.
- 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.
- Ability to work designated schedule.
- Ability to work nights and/or weekends as needed.
- Ability to work on a mobile device, tablet, or in front of a computer screen and/or perform typing for approximately 60% of a typical working day.
- Ability to work on a computer and phone simultaneously.
- Ability to use a telephone through a headset.
- Ability to grasp with both hands; pinch with thumb and forefinger; turn with hand/arm; reach above shoulder height.
- Ability to comply with any applicable personal protective equipment requirements.
- Ability to use various types of laboratory equipment; including microscopes, microtomes, blades, strainers, and pipettes for extended periods of time.
- May perform repetitious actions using lab tools.
- Ability to use near vision to view samples at close range.
- May be exposed to hazardous materials, tissue specimens, and instruments with moving parts, lasers, heating and freezing elements, and high-speed centrifugation.
Minimum Qualifications
- Minimum B.S. in a relevant biological or clinical science discipline.
- 6+ years of relevant laboratory operations and/or R&D experiences.
- 3+ years of management experiences with proven track records of planning and implementing changes, scaling operations for growth, staff development, and building successful teams.
- Exceptional leadership, management, and communication skills and a strong desire to provide superb service to internal and external customers.
- Experience in applying project management skills to plan and implement operational expansion and process improvement projects.
- Experience with using Laboratory Information Management Systems (LIMS).
- Experience with high volume laboratory operations.
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