Principal Toxicologist

Job DescriptionAs a Toxicologist your responsibilities will include, but are not limited to, the following:Prepare hazard identification and toxicology risk / safety assessments for impurities, excipients, leachables, extractables, etc.Conduct SAR and QSAR modelling of compoundsReview, interpret, and position data (study reports, literature, safety data)Conduct technical dossier gap analysis and independent data reviewsValidity review of performed studiesRemain abreast of advances in the fieldActively participate in US working groups for standards development (e.g., AAMI)Provide technical support and guidance on client callsServe as a thought leader and mentor to junior members of the teamEssential Duties and Responsibilities:Applies GMP/GLP in all areas of responsibility, as appropriateMeets all quality and productivity metrics and demonstrates strong teamwork and collaborationPerforms laboratory operations with good dexterity, good laboratory technique, and high degree of accuracy and precisionPerform/review preparations of reagents, samples, and standards according to procedures.Perform routine, non-routine and complex analyses; instrumental analyses; including calibration and troubleshooting/repair of instruments independentlyMake technical decisions without consulting managementGuide and mentor junior staff to successfully complete projects and grow technical knowledgeDo independent research into regulatory trends and technical advancesBe a technical resource for internal problems throughout ELLIProvide support for corporate initiatives through BPT networkProvide coverage for management when neededDocument testing, observations, deviations, and results clearly and completely, and in compliance with regulatory requirements - striving to minimize errorsUnderstand and perform calculations as required by test methodsUnderstand and utilize computers for information access, calculations, and report preparationRead and understand analytical procedures (compendial and client supplied) and internal SOP'sAssist with onboarding new instrumentation, including performing/reviewing IQ/OQ/PQ data or qualificationsProvide consultation for clientsDemonstrate technical writing skills and complete investigations independentlyDemonstrate leadership qualities including;Effective communicationDisplay confidenceDemonstrate motivation and take initiativeFollow through on assignmentsProcess/review data, generate/review reports, and evaluate dataCommunicate effectively, both orally and in writingSuggest and implement lab improvements or modify existing processes to maximize quality and productivity; support and drive LEAN initiativesSupport or identify speaking or publishing opportunities and assist with driving to publication or presentationCommitment to occasional overtime as workload requires