Laboratory Manager-Genetic Tox

Employer
Inotiv
Location
Raleigh, NC
Posted
May 28, 2022
Ref
1545
Required Education
Bachelors Degree
Position Type
Full time
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.

 

Essential Responsibilities

  • Responsible for equipment management in support of the Genetic Toxicology Laboratories.
  • Work with Study Directors, Project Managers, and other departments to coordinate all laboratory related activities, establish work priorities, and ensure deadlines are met.
  • Responsible for the day-to-day management and oversight of the laboratory personnel in the performance of assay procedures in compliance with study protocols and applicable SOPs.
  • Monitor, assess, and review the efficiency and effectiveness of the laboratory.
  • Schedule and supervise laboratory staff to meet or exceed productivity and quality goals.
  • Work with the Quality Assurance Unit to monitor quality standards and regulatory requirements, especially with regards to laboratory equipment.
  • Oversee inventory control to ensure adequate supplies and availability of materials to avoid delays in laboratory testing.
  • Maintain laboratory paper and electronic records.
  • Attend and conduct meetings of laboratory staff.
  • Maintain a working knowledge of all genetic toxicology assays.
  • Troubleshoot problems arising during performance of assays and have an awareness of the factors that can influence results.
  • Schedule and document preventative maintenance and necessary repairs for all equipment.
  • Review equipment logs and facilitate proper documentation of routine maintenance and repair of laboratory equipment regularly.
  • Provide oversight of the equipment monitoring system.
  • Coordinate/participate in equipment validation efforts.
  • Manage equipment and laboratory-related CAPA.
  • Address any equipment or laboratory-related findings on client and internal facility audits.
  • Act as liaison with supply consignment company to ensure inventory is maintained and resolve any problems related to supplies and reagents obtained through that supplier.
  • Manage inventory and ordering of supplies and reagents not handled through the consignment company.

 

Additional Responsibilities

  • Assist in the development of SOPs, forms, and other laboratory documentation.
  • Assist in the design of training and proficiency programs.
  • Communicate with Study Directors, Project Managers, and Division Directors to coordinate activities, ensure alignment of priorities, provide timely notification of issues, etc.
  • Offer constructive/creative suggestions for improvements to equipment, laboratory maintenance procedures, acquisition of supplies and reagents, staff allocation to improve work quality and staff efficiency; implement changes when agreed upon by departmental management. 
  • Assist in managing quality assurance programs.
  • Ensure that all facets of personnel, equipment, documentation, and procedures are compliant with regulatory agencies.

 

Minimum Acceptable Qualifications

Education/Experience:

  • Position requires a minimum of a Bachelor’s degree in biological science or related field, and a minimum of 3+ years of combined laboratory management experience, preferably in a GxP-compliant environment.
  • Experience with relevant genetic toxicology assays (Ames, micronucleus, comet) highly preferred.

 

Skills and Abilities:

  • Basic laboratory skills, e.g., accurate pipetting technique, knowledge of aseptic procedures, etc., and familiarity with equipment and instrument maintenance required.
  • A strong knowledge of MS Office, including Word, Excel, and PowerPoint required; experience using Project Management or other spreadsheet software desirable.

  • Ability to differentiate colors.

  • Knowledge of GLP regulations applicable to non-clinical or clinical safety testing required; knowledge of other regulatory platforms (e.g., GMP, CLIA) may substitute.

  • Interact with clients, other employees, and the community in a professional manner

  • The ability to manage multiple and rapidly changing priorities, organize, set priorities, and exercise sound independent judgment within areas of responsibility.
  • Effective organizational, written, and oral communication skills
  • Ability to adhere to all company policies, safety regulations and procedures
  • Maintain confidential information
  • Support and participate in other company initiatives as directed
  • Ability to read, write, speak, and understand English
  • Demonstrate Inotiv Core Values and adhere to Code of Conduct

 Supervisory Responsibility

  • This position may directly supervise some laboratory staff.

 

Working Environment

  • Primarily laboratory environment with ability to wear a respirator.
  • Frequent office work.
  • Potential exposure to biological fluids, including possible infectious organisms, toxic materials and hazardous waste (appropriate safety training will be provided); possible infrequent exposure to rodents.
  • Personal protective equipment, such as protective eyewear, laboratory coats, and gloves, required in the laboratories.
  • Routinely uses standard office equipment such as computers, phones, photocopiers, and filing cabinets.

 

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 participation with company match, etc. 

 

Inotiv is a proud equal opportunity employer and an E-Verify employer.