Senior Manager, Global Toxicologist – Occupational & Environmental Toxicology

Responsibilities

• Lead the global occupational and environmental toxicology strategy across all business segments.
• Serve as the enterprise technical authority for toxicological risk assessment involving APIs, HPAPIs, biologics, solvents, cleaning agents, emerging therapeutic modalities and similar.
• Develop and maintain global toxicology standards, governance processes, and scientific methodologies.
• Establish and review occupational exposure limits (OELs), occupational exposure bands (OEBs), acceptable daily exposures (ADEs), and permitted daily exposures (PDEs).
• Develop PCI internal occupational and environmental toxicology monograph template(s).
• Lead development of Occupational Toxicology and Industrial Hygiene capabilities, including utilization of QSAR, predictive analytics and computational modeling.
• Conduct hazard characterization, complete PCI Health Hazard Assessments (HHAs), complete monographs, and conduct dose-response evaluations using available toxicological and pharmacological data.
• Partner with Engineering, EHS, Operations, and Quality teams to evaluate containment performance and exposure control effectiveness.
• Support medical surveillance and occupational health programs by identifying exposure-related health risks and appropriate monitoring strategies.
• Participate in incident investigations involving occupational exposures or potential toxicological impacts.
• Provide technical leadership for and complete environmental hazard assessments and ecological toxicology evaluations.
• Support environmental compliance programs involving air emissions, wastewater, hazardous waste, and chemical management.
• Assist in the development of an Industrial Hygiene exposure monitoring plan, complete regular industrial hygiene monitoring against the plan and/or analyze collected industrial hygiene data to support control and personal protective equipment decisions and to validate the effectiveness of controls.
• Educate internal stakeholders on toxicology principles, exposure risk management, and hazard communication and develop/deliver training for EHS professionals, operations teams, leadership, and clients.
• Serve as a technical representative during regulatory inspections, client audits, due diligence activities, and industry forums.
• Translate complex toxicological data into practical operational guidance for both technical and non-technical audiences.
• Build credibility with clients and external stakeholders through strong scientific communication and consultative partnership.
• Monitor evolving global toxicology regulations, scientific guidance, and industry best practices to support compliance with pharmaceutical regulatory expectations.
• Innovate the Global Industrial Hygiene data management systems and processes to enhance the use of data within the group.

• Masters Degree in Toxicology or similar field and 7+ years of progressive toxicology experience within pharmaceutical, biologics, chemical manufacturing, consulting, or CDMO environments
• Doctorate Degree in Toxicology or similar field and 3+ years of progressive toxicology experience within pharmaceutical, biologics, chemical manufacturing, consulting, or CDMO environments
• Experience supporting global manufacturing and laboratory operations.
• Strong expertise in occupational and environmental toxicology, exposure assessment, and risk characterization.
• Diplomate of the American Board of Toxicology (DABT) accreditation or ability & qualifications to obtain DABT
• Ability to perform the most complex computer tasks and operate various computer programs.
• Full Professional Proficiency:
  Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs.
• Very High Reasoning:
  Ability to define problems, collect data, establish facts, and draw valid conclusions.
• High Standard of Report Writing
• Ability to work independently and/or as part of a team.
• Ability to show success in managing employees (Preferred)
• Experience in hazard/risk assessment within pharmaceuticals and/or bio-pharmaceuticals industry (Preferred)
• Pharmaceutical compound risk assessment training (Preferred)

• Toxicological Risk Assessment
• Hazard Characterization
• Dose-Response Evaluation
• QSAR Modeling
• Predictive Analytics
• Computational Modeling
• Industrial Hygiene Monitoring
• Environmental Hazard Assessment
• Data Management Systems
• Report Writing

• Strong Scientific Communication
• Team Collaboration
• Independent Work
• Problem Solving
• Training Development

• DABT Accreditation