Advisor - Risk Assessment and Occupational Toxicologist

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 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.

The Department of Nonclinical Safety Assessment within the Division of Toxicology/Pathology is searching for a Risk Assessment Scientist to join our team. Are you looking for an opportunity to contribute to and make an impact in the drug development field? The successful candidate will provide scientific leadership and drug development expertise through this vital role in supporting the completion of comprehensive human health risk assessments for active pharmaceutical ingredients (API's) throughout the drug development process. The role will collaborate closely with toxicologists, CMC manufacturing, and cross functional teams to ensure compliance with evolving regulatory requirements, thereby helping to ensure work safety and product quality and playing an integral part in developing world-class medicines for patients.

Responsibilities:

Workplace Safety Risk Assessment

• Conducting and communicating risk assessments for new molecular entities (NMEs) and established products (EPs)
• Develop workplace exposure guidelines, such as OEL/OEB, using appropriate risk assessment methods across various stages of drug development
• Apply company exposure limit banding strategy at early stages of development
• Derive data-based exposure limits at later stages of development, incorporating both nonclinical and clinical data

Product Safety Risk Assessment

• Assess impact of manufacturing deviations
• Develop toxicology opinions for issues related to patient safety and regulatory compliance
• Develop impurity permissible/acceptable daily exposure (PDE/ADE) values for raw materials, excipients, salts, etc.
• 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 resolution of manufacturing deviations.
• Assess risk of genotoxic impurities based on relevant guidance and develop acceptable limits
• Apply toxicology knowledge to establish health-based permitted daily exposure levels (PDE's) for API's throughout their synthesis stages
• Provide training and hazard information on occupational health including safety data sheet reviews and reproductive hazard assessments
• Assist in monitoring ongoing toxicology studies to ensure adherence to protocols and regulations
• Leverage occupational toxicology knowledge to provide scientific support for small molecules, antibody drug conjugates (ADC) and other modalities
• Collaborate with internal teams to enhance risk assessment efficacy and adapt to emerging regulations
• Perform other essential tasks projects and responsibilities as required.

Basic Qualifications:

MS or PhD in Toxicology, Risk Assessment Toxicology, Hazard Assessment Toxicology, Occupational Toxicology, or Product Quality Toxicology with a minimum of 3-5 years relevant experience, preferably in the pharmaceutical industry.

Additional Skills/Preferences:

• Extensive toxicology knowledge of health-based permitted daily exposure levels (PDE's) and occupational exposure limits (OEL's) for API's throughout the development stages of small molecules, antibody drug conjugates (ADC), and other modalities
• Have in depth understanding of hazard information on occupational health and reproductive hazard assessments
• Be up to date on current toxicology regulations and guidelines including but not limited to ICH Q3 A-D, E; ICH M7; ISO10993; OECD 471/488
• Possess strong collaborative skills, be highly organized, demonstrate excellent attention to detail.
• Must be a self-starter able to dive into work streams as needed and to complete tasks in a prompt and efficient manner.
• Ability to work in a fast paced environment and adapt quickly to changing company needs

Location: Indianapolis, IN

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is

$121,500 - $198,000

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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