Eli Lilly and Company

Human Health Risk Assessment Toxicologist

Location
Indianapolis, IN, United States
Posted
Oct 05, 2018
Ref
44222
Discipline
Science/R&D, Toxicology
Required Education
Bachelors Degree
Position Type
Full time
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 39,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.

Responsibilities

It is an exciting time to join Lilly as we strive to improve the lives of our patients. Our Risk Assessment Toxicology group is looking to add a new team member. Do you have experience in Human Health Risk Assessment or Occupational Toxicology? In this role you are accountable for delivering expert opinions to internal and external Lilly customers globally in support of product and workplace safety issues. Are you adept at interpreting scientific or medical literature or data? Do you enjoy working with a diverse organization to complete projects? We need a dynamic individual to join our team to address a wide variety of complex workplace and product issues in order to assure safety of patients and employees. You will collaborate with individuals from manufacturing, health/safety/environmental, and chemistry, quality, and governance committees. You will be responsible for effective interactions and communication of scientific expertise while providing rigorous and timely human health risk assessments with cross-functional impact. It will be necessary for you to keep up-to-date on pertinent regulatory guidance and manage key compliance objectives. This role offers the opportunity to impact the safety for our employees and patients, and also encourages creative thinking to improve risk assessment practices within the company.
Some Key Objectives:

Workplace Safety Risk Assessment
  • Develop workplace exposure guidelines (WEG) using appropriate risk assessment methods, author each guideline document, present rationale to review committee, and finalize by projected target dates.
  • Subject matter/technical authority for evaluating early development compounds against Lilly's default containment level.
  • Maintain/manage collaboration sites for Early Evaluation of High Risk Compounds, Containment Designations, and Workplace Exposure Guidelines.
  • Oversee WEG information sharing between Risk Assessment Toxicology and Global Hazard Communication as well as groups responsible for external manufacturing.
  • Evaluate portfolio resources to prioritize WEG deliverables.
  • Liaison with health and safety experts for inquiries regarding communication and conduct of safe practices in the workplace.

Product Safety Risk Assessment
  • Develop toxicology opinions for issues related to patient safety and regulatory compliance. For instance, acceptable daily exposure (ADE) values are a regulatory expectation for application in cleaning validation.
  • Maintain/manage ADE tracking collaboration site.
  • Retrieve, review, interpret, and summarize scientific data for a variety of chemicals involved in the development and manufacture of pharmaceuticals.
  • Use current risk assessment principles to develop toxicology-based impurity limits applied for support of specifications, leachables/extractables, equipment cleaning, and in the resolution of manufacturing deviations.
  • Work with customers directly to assist in problem identification, framing, and strategy decisions.

Innovation
  • Leverage internal and external (regulatory and industry) relationships to handle emerging issues and make innovations in risk assessment practices for increased productivity, efficiency, and compliance.
44222BR

Basic Qualifications
  • Bachelor's or Master's degree in toxicology, public health, or related scientific field.
  • Experience in Human Health Risk Assessment preferred
  • Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.


Additional Skills/Preferences
  • Experience in the conduct and monitoring of non-clinical or clinical studies is helpful.
  • Excellent written and verbal communication skills. Aptitude for technical writing and presentation skills.
  • Ability to effectively prioritize multiple tasks and complete projects in a timely fashion. Aptitude for complex, analytical work. Strong self-start and self-management skills.
  • Works both independently and as a strong collaborative member of diverse teams. Demonstrated problem-solving and project management skills.
  • Knowledge of human health risk assessment methodology.
  • Experience interpreting nonclinical or clinical data.


Additional Information
Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.