1800 Concord Pik Gaithersburg, MD 20878
Providing expertise for hazard and risk assessment (primarily occupational and product quality-related toxicology) within Global Safety, Health and Environment (GSHE). Contributes to the overall strategy that enables a harmonized and consistent approach for occupational toxicology and product quality disciplines across the entire product pipeline, including biologically-derived and chemically synthesized bio/pharmaceuticals from development through commercialization.
Applied experience PhD or Board Cert. or Masters and several years writing monographs
Experience writing product risks
• Advanced degree in pharmacology, toxicology, Industrial/Occupational Health or related biomedical science field.
• Four+ years in hazard/risk assessment within pharmaceuticals and/or biopharmaceuticals industry.
• Proven proficiency in technical science writing, specifically regarding chemical monographs for risk assessment.
• Experience in toxicology assessments for both occupational (e.g. worker exposure) and product quality (e.g., patient safety).
• Fluency in relevant international regulations and guidelines for both worker and product safety (EMA, FDA, ICH, ISO, USP, OSHA, COSH, etc.).
• Applied, working knowledge of the general principles, practices and procedures of multiple facets including pharmacology, toxicology, biology, and chemistry and the relationship between toxicological, physical, and chemical properties of small and/or large molecule pharmaceuticals and biologics.
• Effective problem and conflict resolution skills and proven team focus.
• Excellent written and verbal communication skills as well as proven negotiation, collaboration and interpersonal leadership skills.
• Ability to influence strategically and persuade tactfully, to obtain desired outcomes while maintaining effective, positive, organizational relationships.
• Professional Business Qualification/Certifications (e.g., DABT, ERT, CIH).
• Occupational Health and Industrial Hygiene experience: occupational exposure assessment and controls; containment strategies and worker protection.
• Operational expertise in risk management and contingency planning: o working understanding of risk in terms of hazard (toxicology) and exposure/controls (industrial hygiene)
• Willingness to travel both domestically and internationally.
• May be required to liaise with external topic experts and customers/suppliers.