Manager, Histology

Exact SciencesMadison, WI
Onsite

About The Position

The Histology Manager is responsible for the operation and leadership of the Exact Sciences Histology Laboratory and its designated team. This role involves continually enhancing the team's capabilities to adapt to new products, laboratory information management systems, processes, and increasing sample volumes. The manager will collaborate with various departments to ensure the quality and timeliness of patient and study sample processing, and will be accountable for the Histology team's deliverables on product and process development projects. Key responsibilities include facilitating communication with Customer Service, Pathology, and the Analytical Laboratory regarding service coverage and issue resolution, adjusting staffing as needed. The Histology Manager ensures compliance with regulatory requirements and company policies, monitors quality and performance metrics, and implements process and quality improvement initiatives. The position demands excellent attention to detail, effective communication, and a commitment to employee development due to the high volume and stringent quality requirements. The manager must work both independently and collaboratively, fostering teamwork within Histology and with other functional areas. This role acts as a liaison with groups such as Customer Service, Pathology, Analytical Laboratory, Biomaterials Repository, Quality, Service Engineering, Process Engineering, Information Technology, Reagent Quality, Biostatistics, Supply Chain Management, and Facilities. The manager will anticipate business growth by developing plans for staffing, equipment, and space, contribute to business management by analyzing production costs, assisting in budgeting, troubleshooting problems, coaching staff, building teams, and managing projects. The position includes hiring, managing, developing, and motivating Histology staff, including the management team, and preparing the laboratory for internal and external inspections. The Histology Manager will also be involved in scheduling and direct supervision of daily laboratory processes, requiring outstanding leadership, operational management, organizational skills, the ability to analyze complex issues, make sound decisions, remain professional under pressure, and communicate effectively across the organization.

Requirements

  • 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.
  • Proficiency in using word processing and spreadsheet applications.
  • Working knowledge of local, state and federal regulatory requirements for the Clinical Laboratory and experience with CLIA laboratory inspections or equivalent.
  • Ability to quickly adopt and apply new methods and technologies.
  • Ability to quickly and calmly adapt and respond to changes in priorities, timelines and deliverables.
  • Ability to communicate clearly and effectively in writing and verbally to technical and non-technical audiences.
  • Ability to analyze and solve complex issues that impact laboratory processes.
  • Ability to integrate and apply feedback in a professional manner.
  • Ability to prioritize and drive to results with a high emphasis on quality.
  • Ability to work as part of a team.

Nice To Haves

  • ASCP Board of Certification or equivalent, e.g. HT(ASCP), HLT(ASCP).
  • 6+ years of experience in a histology laboratory performing tissue processing techniques; including sectioning, slide preparation, H&E staining, macrodissecting, IHC processing, tissue embedding, and process troubleshooting.
  • Experience with one or more Histological techniques/platforms, such as Digital Pathology.
  • Familiarity with standard molecular biology techniques such as nucleic acid isolation, RNA/DNA quantification, PCR and RT-PCR, DNA sequencing.

Responsibilities

  • 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.

Benefits

  • paid time off (including days for vacation, holidays, volunteering, and personal time)
  • paid leave for parents and caregivers
  • a retirement savings plan
  • wellness support
  • health benefits including medical, prescription drug, dental, and vision coverage

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What This Job Offers

Job Type

Full-time

Career Level

Manager

Number of Employees

1,001-5,000 employees

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