Johnson & Johnson Careers
Senior Scientist- Toxicology/Clinical Safety
Requisition ID: 1905718418W
Job Title: Senior Scientist-Toxicology & Clinical Safety (skin tolerance)
Department: Toxicology Resource Centre
Job Location: Mumbai
Position Summary: JnJ consumer division has products in beauty, baby, oral care, topical healthcare, personal hygiene and OTC franchises. Toxicology Resource Centre is engaged in the conduct of safety assessment of ingredients and products.
This position involves toxicology risk assessment of ingredients, finished products, impurities and degradants and topical skin safety for consumer products with the help of data search and interpretation. The role does not involve any laboratory work. This position also requires study monitoring at CROs. The candidate is expected to have qualifications in Toxicology/ clinical safety and experience in either conduct of invitro /in vivo Toxicology studies and /or skin tolerance studies, risk assessment and skills of good medical writing. The role also includes coordination of work with third party contractors, reviewing activities and assessments. Good communication skills are required for optimum job completion.
• Literature search & safety data (preclinical and clinical) collection for identified issues seeking toxicology and/or clinical safety (skin tolerance) support.
• Literature review for hazard assessment of ingredients intended to be used in consumer and preparation of their toxicology profiles.
• Assessment and approval of fragrances and flavors used in consumer products.
• Toxicology Risk assessment for raw materials and formulations for cosmetic applications including Margin of Safety calculations and approval of products.
• Assessment of skin tolerance of cosmetic ingredients and products from preclinical and clinical perspectives.
• Review and Interpretation of clinical skin safety studies (patch test, phototoxicity, irritation and sensitization studies)
• Safety assessments for impurities, degradants and products as per regulatory requirements.
• Review of products at different stages of development cycle
• Preparation of technical justification reports for regulatory submission.
• Addressing and evaluating the risk of compliance issues raised by regulatory authorities & QA, and impurity qualification
• Toxicology/clinical Study monitoring, interpretation and managing third party
• Communication with business partners on requirements, prioritization and deliverables on safety assessment reports
• Review of activities conducted by third party associates
• Maintain documents via the product safety & compliance SharePoint site.
Minimum required Qualification / Experience / Exposures:
• Master’s degree/ Ph.D. in toxicology, pharmacology or relevant science discipline.
• 3-5 years of experience in the field of consumer product risk assessment or other relevant Toxicology and/or Clinical safety (skin tolerance) experience.
• Diplomate of the American Board of Toxicology (DABT) certification, Diploma in clinical sciences preferred.
• In silico predictions
• Good verbal and written communication skill in English is a must.
• Individual with strong interpersonal skills and able to work independently
• Desirable: Knowledge of regulatory requirements for product safety submissions and experience in medical writing.
Johnson & Johnson Private Limited (8080)