Experienced in multiple facets of occupational and environmental toxicology. GLP Toxicity Testing, Occupational Exposure Limits (OELs) Occupational Exposure Band (OEBs), Safety Data Sheets (SDSs), Chemical Hazard and Risk Assessment for process, product and manufacturing impurities (ICH). Work with teams implementing controls in potent pharmaceutical actives including sensitizers and hormones integrated with Industrial Hygiene and Operations across pharmaceutical research and manufacturing. Expert in planning, budgeting, implementing and manager of multiyear toxicology testing programs for occupational and environmental evaluations. Prepare pharmaceutical environmental risk assessments for agency submissions (EMA). Establish PDEs for cleaning limits. Train and mentor staff. Set up and manage SDS systems. Conducting portfolio reviews for long term planning and resource needs assessment. Lead and participate in process improvement teams. Track environmental issues for analysis and corporate action from industry groups. Specialties: Occupational and Environmental Risk Assessments, OEL/OEB, Impurity Assessments, SDS & Hazard Communications, Product Stewardship, Mammalian and Environmental Toxicity Testing
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Principal ToxicologistVeranovaNew York, Ny, Us
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Product Stewardship And Toxicology ManagerVeranova Jan 2023 - PresentManaging Product Stewardship and Toxicology of API, Intermediates and starting materials for Veranova manufacturing and development operations globally as part of EHS. Conducting modeling, banding, OEL development, SDS authoring and management.
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Senior Manager, ToxicologyArxada Jan 2021 - Sep 2022New Jersey, United StatesManaging a global team of toxicologist conducting toxicology testing, regulatory risk assessments and hazard assessments for specialty chemicals. Supporting global regulatory submission, product development, and product stewardship to the US EPA, European BPR and other regions. -
Toxicologist IiiIes Engineers May 2017 - Dec 2020Blue Bell, PaProvide expertise in occupational and environmental toxicology for research and manufacturing facilities including cleaning limits and impurity support for multiple clients. Establish occupational exposure bands (OEBs), limits (OELs) and permitted daily exposures (PDEs) for pharmaceutical actives and Safety Data Sheets (SDS) for actives and products. Support and advise toxicology testing programs for regulatory filings worldwide using GLP CROs testing for environmental and occupational toxicity for active pharmaceuticals, intermediates, impurities, degradants and excipients being filed in US, EMA, REACH and China-REACH.Prepare Environmental Risk Assessments for regulatory filings -
ToxicologistPurdue Pharma L.P. Oct 2011 - May 2017Cranbury, NjManage toxicology testing programs for regulatory filings worldwide using GLP CROs testing for general toxicity, genotoxicity, reprotoxicity, and carcinogenicity via oral and dermal routes for active pharmaceuticals, intermediates, impurities and degradants of actives and excipients. Prepare due diligence toxicology assessments for business development opportunities. Provide expertise in occupational and environmental toxicology for research and manufacturing facilities including cleaning limits and EHS support. Prepare sections of and support FDA filings and Regulatory Affairs. Review corporate Safety Data Sheets (SDS) for regulatory (GHS, OSHA) compliance. -
Manager Of Ehs, Environmental & Occupational ToxicologyBristol-Myers Squibb Aug 2008 - Oct 2011New Brunswick, NjManage the environmental toxicology testing to support submission to regulatory agencies. Write Environmental Assessments for drug applications in the US (NDA) and the EU (MAA). Support global EHS issues requiring toxicology support to global facilities. Write toxicology sections of SDS for active ingredients and formulations and labeling classifications. -
Principal Toxicologist- EnvironmentalSchering-Plough Corporation Oct 2002 - Aug 2008Established and managed environmental toxicology testing program to support environmental assessments. Wrote Environmental Assessments for drug applications in the US (NDA) and the EU (MAA). Supported global facilities with: hazard and risk communications on wastewater and remediation issues. Coordinated the authoring of SDS with junior staff and managed group metrics and wrote and reviewed SDSs for use in the U.S., Europe, Canada, and Asia-Pacific. Managed and trained interns, on a MSDS project, and on two environmental data modeling projects.
Nicholas Roden, Drph Education Details
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Public Health-Environmental Occupational Health -
Environmental And Occupational Health
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Biology
Frequently Asked Questions about Nicholas Roden, Drph
What company does Nicholas Roden, Drph work for?
Nicholas Roden, Drph works for Veranova
What is Nicholas Roden, Drph's role at the current company?
Nicholas Roden, Drph's current role is Principal Toxicologist.
What schools did Nicholas Roden, Drph attend?
Nicholas Roden, Drph attended Rutgers University, Rutgers University, Rutgers University.
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