Job Description:

Janssen Research & Development, L.L.C., a division of Johnson & Johnson's Family of Companies, is recruiting for a Senior Scientist, Occupational Toxicology & Product Quality to be remote based in the United States...

At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com and follow us @JanssenGlobal. Janssen Research & Development, LLC is part of the Janssen Pharmaceutical Companies.
Position Summary:

The Senior Scientist will support detailed classification of all biologics, vaccines, small molecules, and new modalities (cell/gene/RNA therapies) to ensure risk assessments are completed accurately and in a timely manner to assure worker safety and support cleaning validation requirements. They will coordinate non-clinical testing of active products and their intermediates as required by regulations, or as needed to complete hazard and risk assessments. Experience in assessing safety of biologic products will be significant in developing and implementing an end-to-end biological safety approach for large molecules, vaccines, and new therapeutic modalities. The successful candidate will generate risk assessments in support of product quality, specifically cleaning validation and minimization of cross-contamination risk assessments.

Responsibilities:
• Supply high quality toxicology risk assessments of potential impurities (drug substance impurities, drug product degradants, extractables and leachables, etc.).
• Support clear hazard communication, employee training, complete documentation of assessments, global harmonization classifications and labeling of Janssen products and intermediates.
• Support activities related to studies placed at contract research organizations (CROs), review contracts and study plans, liaising with non-clinical safety leads, chemistry, and Janssen Biologics for needed work including arranging, monitoring, and evaluating studies for REACH notifications as well as biocompatibility testing to support drug/device development.

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Job ID: j202305211330412073962

Recommended Job Skills: Bug/Defect Tracking, Business Process Modeling/Improvement

Average Estimate Salary for a Senior Scientist, Occupational Toxicology & Product Quality: $56.46 to $68.43

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North Wales PA USA

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