Sr. Manager, Global Toxicologist - Occupational & Environmental Toxicology

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.

We are PCI.

Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.

Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned.

• 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.

Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

The following are some environmental conditions that one may be exposed to on a daily basis and for various lengths of time.

• Work is primarily performed at a desk and/or in an office environment. for 1/4 to 1/2 of the day.
• Work near moving mechanical parts for 1/4 to 1/2 of the day.
• Work in high, precarious places for up to 1/4 of the day.
• Fumes or airborne particles for 1/2 to 3/4 of the day.
• Toxic or caustic chemicals for 1/4 to 1/2 of the day.
• Work is performed in areas with moderate risk or discomfort that may require special safety precautions, such as wearing protective clothing or gear for 1/4 to 1/2 of the day.

The noise level in the work environment is typically, moderate.

Qualifications: The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

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 professional needs.
• Very High Reasoning: Ability to define problems, collect data, establish facts, and draw valid conclusions. Be able to interpret an extensive variety of technical instructions in math or diagram form and deal with several abstract/concrete variables.
• High Standard of Report Writing
• Ability to effectively present information to various people as the job requires.
• Ability to work independently and/or as part of a team.

Preferred:

• Ability to show success in managing employees.
• Experience in hazard/risk assessment within pharmaceuticals and/or bio-pharmaceuticals industry.
• Pharmaceutical compound risk assessment training

#LI-KH1

Join us and be part of building the bridge between life changing therapies and patients. Let's talk future

Equal Employment Opportunity (EEO) Statement:
PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.