Laboratory Manager, Histology

Key Accountabilities

• Provide oversight of overall histology laboratory operations for the Medical Device Pathology Department to ensure the on-time delivery of high-quality slides and/or data in a regulatory environment.
• Oversee and coordinate all histology laboratory activities, including study timelines, equipment maintenance, protocol/Standard Operating Procedures (SOPs) reviews, and ordering of chemicals/reagents.
• Maintain full visibility into the status of all histology study activities and communicate any potential impacts to established timelines to the appropriate individuals.
• Ensure that all study conduct complies with the study protocol, SOPs, and all applicable local, federal, and international regulations, including GLP.
• Stay informed of updates or changes in regulatory guidance and collaborate with Quality Assurance to address any identified deficiencies.
• Actively and effectively communicate with all stakeholders involved in histology laboratory activities (e.g., Study Pathologists, Study Directors, Quality Assurance, upper management, staff, other test sites, contractors, and clients).
• Ensure laboratory equipment is well maintained (i.e., preventive, routine, and non-routine maintenance) and appropriately calibrated, as necessary.
• Perform equipment/software qualification and/or validation, as needed.
• Oversee and assist, in conjunction with the Study Director, Study Pathologist, and/or Sponsor, with tissue trimming.
• Oversee paraffin and plastic processing, slide generation, cytochemical staining (e.g., hematoxylin and eosin, Masson's Trichrome), and immunohistochemistry (IHC) staining, as needed.
• Collaborate with Study Directors, Study Pathologists, Principal Investigators, Sponsors, and/or other test sites to achieve specific analytical endpoints (e.g., micro-CT, SEM, mechanical testing), while developing strategies to minimize impacts on tissue quality for other endpoints (e.g., histology).
• When an untested device is to be histologically processed, work with the Sponsor, Study Director, and Study Pathologist to conduct a pilot study to determine the optimal processing method prior to full study implementation.
• Handle and ship tissue samples in compliance with regulations governing the shipment of biohazardous materials, as required.
• Directly supervise up to five staff members, including Histology Technicians and other Laboratory Support Staff, as applicable.
• Ensure histology staff are properly trained and that their training records are up to date. Training must include, at a minimum:
  • Specialized histological procedures (e.g., frozen sections, plastics processing)
  • Laboratory safety (e.g., chemical hazards, waste management)
  • Proper use of personal protective equipment (PPE)
• Hold staff accountable for meeting deadlines, maintaining quality control (QC), and overall work performance.
• Conduct staff performance evaluations and recommend merit increases, as appropriate.
• Participate in interviewing and hiring of technical staff.
• Monitor laboratory expenses (e.g., wages, equipment, supplies, and maintenance/repair costs).
• Monitor daily laboratory equipment conditions (e.g., temperature ranges for ovens, refrigerators, and freezers).
• Contribute to the development of new assays, methods, and processes, and propose innovative, well-reasoned solutions to complex problems.
• Delegate laboratory responsibilities, as needed.

Other

• Follows all SOPs and other applicable laboratory or company policies and procedures.
• Maintains confidential information.
• Supports and participates in company initiatives as directed.

• Performs periodic review of all applicable SOPs to ensure accuracy and confirm procedures are being performed according to SOPs.Participates in SOP writing, review, and revision, as needed.
• Completes training requirements as assigned and maintains appropriate training documentation.
• Maintains compliance and adheres to all safety regulations, policies, and procedures and good documentation practices.
• Maintains a thorough knowledge and ensures compliance with Good Laboratory Practices (GLP), United States Department of Agriculture (USDA), Association of Assessment and Accreditation of Laboratory Animal Care (AAALAC), Office of Laboratory Animal Welfare (OLAW), and other applicable regulations.
• Interact with clients, other employees, and the community in a professional manner.

• Performs other duties as assigned.

Critical Success Factors

• Customer Focused: Identifies, prioritizes and anticipates customer needs and delivers relevant, value-add, solutions to meet and exceed them.
• Results Driven: Internal drive toward action to efficiently, timely, and accurately achieve results. Sets high but achievable standards for self and others. Seeks opportunities to improve process and outcomes. Constantly reviews performance to identify areas to develop.
• Efficient: Takes responsibility for own time and effectiveness. Identifies what needs to be done and does it before being asked or before the situation requires it. Able to work things out without having to be shown too often. Seeks opportunities to contribute appropriately without direction.
• Relationship Builder: Develops, maintains, and strengthens strong partnerships with others internally and externally, cross functionally, in person and remotely.
• Critical thinking and problem solving: Able to identify and separate out the key components of problems and situations. Able to manipulate and interpret information from a range of sources to spot patterns and trends in information and to deduce cause and effect from this. Can generate a range of creative solutions, evaluate, and choose the most appropriate option.
• Organization and time management: Plans and prioritizes work, manages time appropriately to meet deadlines, follows up with others to ensure one's own work and commitments are completed on time, deals with pressure and deadlines through good planning.
• Strong leadership, organizational, and problem-solving skills, with the ability to work independently and/or with little supervision.
• Effective and professional communication/collaborative skills with the team including Study Pathologists, Study Directors, Quality Assurance (QA), upper management, staff, as well as other test sites, contractors, and clients.
• Ability and willingness to work in partnership with QA to address any identified regulatory deficiencies.
• Knowledge and experience with regulations from applicable state and national regulatory agencies, including Good Laboratory Practice (GLP), with the ability to apply these practices as they pertain to histology laboratory operations.
• Experience in writing, reviewing, and editing study protocols and SOPs.
• Strong attention to detail and an aptitude to properly document and retain all pertinent information as outlined in study protocols and/or Standard Operating Procedures (SOPs).
• Implementation of and strict adherence to safety regulations and procedures (e.g., wearing the appropriate Personal Protective Equipment [PPE]).
• Sound foundation and experience, at a minimum, in paraffin, with a preferred background/understanding in plastics (e.g., methyl methacrylate [MMA], Spurr, etc.), and frozen histology.
• Knowledge of and experience with various animal models and animal anatomy as related to medical device work.
• Ability to compile and synthesize a wide array of data sets (e.g., chemical inventory, equipment maintenance schedule, laboratory operations, etc.) and provide cogent responses/reports based on the analysis of the data set.
• Ability to delegate laboratory responsibilities, as needed.

Minimum Requirements

• Associates degree is life sciences or similar
• Three years' experience in managing a histology laboratory, preferably as within medical device histopathology

Preferred Qualifications

• Bachelor's degree in Life Sciences
• Histology Certification
• Five years of demonstrated leadership, organizational, and problem-solving experience in a histology or related laboratory setting
• Three years of experience supervising or delegating responsibilities to histology technicians or laboratory support staff
• One year of working knowledge and application of Good Laboratory Practice (GLP) and other applicable regulatory standards in histology laboratory operations
• One year experience collaborating with cross functional teams
• One year of hands-on experience with paraffin, plastic (e.g. methyl methacrylate) and frozen histology techniques

Working Conditions & Physical Requirements

The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

(The phrases "occasionally," "regularly," and "frequently" correspond to the following definitions: "occasionally" means up to one-third of working time, "regularly" means between one-third and two-thirds of working time, and "frequently" means two-thirds and more of working time.)

General

• Ability to read, write, speak, and understand English.
• Ability to read, write, and understand oral and written instructions.

Physical Activity

• Frequent/extended periods of standing, walking, sitting, bending, and/or lifting.
• Ability to lift up to 50 pounds to a height of 5 feet.
• Manual dexterity related to, but not limited to:
  • Gripping and twisting hand movements.
  • Tissue trimming.
  • Operating laboratory equipment (e.g., embedders, microtome, grinders, saws, etc.).
  • Fine motor skills (e.g., techniques related to slide preparation [manual coverslipping], etc.).
  • Computer/keyboard work.
• General repetitive motion.

Working Conditions

• Frequent involvement with:
  • Radiant/electrical/radioactive energy (e.g., faxitron, etc.).
  • Solvents, grease/oils, irritants, acids, bases, and other hazardous chemicals.
  • Electro-mechanical hazards.
  • Flammable materials.
  • Biohazards.

Note: all reasonable measures will be taken to mitigate exposure to the items listed above. In addition, due to exposure to hazardous biological materials, immunization to disease(s) may be required.

• Donning of appropriate PPE (e.g., latex or nitrile gloves, dust mask and/or respirator, safety glasses, etc.) as required.
• Tolerance of minimal odors and chemical fumes (all practical measures to eliminate lab odors will be taken).
• Moderate noise level associated with mechanical pumps, saws, and grinders.

Tools, Equipment, & Other Resources Used

• Various Windows based computer software/platforms (e.g., Excel, Word, PowerPoint, Outlook, Teams, etc.).
• General histology laboratory equipment (e.g., tissue processors, embedding centers, autostainers, microtomes, saws, grinders, slide/cassette labelers, etc.).

This position could be offered at different levels for candidates who qualify with a combination of advanced levels of education and/or years of experience. The salary range is $92,200 - $120,000/ year and will adjust along with the level of the role to match the person's relevant experience and/or education level. Benefits include health and dental coverage, short- and long-term disability, paid time off, paid parental leave, 401K, and more!

*This position could be offered at different levels for candidates who qualify with a combination of advanced levels of education and/or years of experience. The salary range will adjust along with the level of the role to match the person's relevant experience and/or education level.

Inotiv is a growing contemporary drug discovery and development company where we "Play to Win" in an industry rich with opportunity. Together, we face challenges and together we win in the delivery of world-class drug discovery and development solutions that impact the health and well-being of people all over the world. There's an opportunity for everyone at all phases of a career, each individual's unique skill set has an impact on the work we conduct. If you have the talent and desire to impact the quality of people's lives, we have the career opportunities to make it happen. Join us in embracing research and science to impact the health and well-being of people all over the world.

Salary will be commensurate with experience and responsibilities. Benefits include health and dental coverage, short- and long-term disability, paid time off, paid parental leave, 401K, and more!

Inotiv is an Equal Opportunity Employer. It is our policy to provide a fair and equal employment opportunity to all persons, regardless of age, race, color, religion, sex, gender, gender identity, gender expression, sexual orientation, genetic information, disability, national origin, veteran status, or any other basis prohibited by law. This policy governs all aspects of employment, including selection, job assignment, compensation, discipline, termination and access to benefits and training.