Sr. 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. This position will require travel to PCI global sites to ensure compliance with processes and programs, support initiatives, and provide training. This position may require overtime and/or weekend work.

Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules. Attendance to work is an essential function of this position. Performs other duties as assigned by Manager/Supervisor.

Required:

Masters Degree in Toxicology or similar field and 7+ years of progressive toxicology experience within pharmaceutical, biologics, chemical manufacturing, consulting, or CDMO environments or 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 College Level Mathematical Skills Advanced Computer

Skills:

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…