BioSpace
Advisor - Risk Assessment and Occupational Toxicologist
BioSpace, Indianapolis, Indiana, us, 46262
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. The Department of Nonclinical Safety Assessment within the Division of Toxicology/Pathology is searching for a Risk Assessment Scientist to join our team. 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. Responsibilities 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 Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. 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.
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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. The Department of Nonclinical Safety Assessment within the Division of Toxicology/Pathology is searching for a Risk Assessment Scientist to join our team. 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. Responsibilities 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 Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. 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.
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