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Senior Analytical Development Analyst – Toxicologist
Aché Laboratórios. Conduct complex toxicological risk assessments, establishing scientific strategies for impurities, nitrosamines, degradation products, contaminants, and materials of regulatory interest .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in conducting toxicological risk assessments and preparing regulatory submissions, with a strong foundation in toxicology principles and cross-functional collaboration within the pharmaceutical industry.
Highest-signal resume keywords
Toxicological Risk AssessmentRegulatory SubmissionsCross-Functional CollaborationAdvanced English ProficiencyIn Silico Prediction Software
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
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Hard Skills
ToxicologyRisk AssessmentRead-AcrossWeight of Evidence (WoE)QSARMutagenicity AssessmentGenotoxicity AssessmentPDE DefinitionAI DefinitionTTC Definition
Certifications & Qualifications
Bachelor’s Degree in PharmacyGraduate Degree in Toxicology
Industry Keywords
ImpuritiesDegradation ProductsContaminantsNitrosaminesICH M7Q3AQ3BEMAFDAANVISA
About the role
Key responsibilities & impact- Conduct complex toxicological risk assessments, establishing scientific strategies for impurities, nitrosamines, degradation products, contaminants, and materials of regulatory interest
- Prepare technical opinions, scientific reports, and regulatory justifications for national and international submissions
- Participate in multidisciplinary technical discussions with Analytical Development, Pharmaceutical Development, Quality, and Regulatory Affairs teams
Requirements
What you’ll need- Bachelor’s degree in Pharmacy or a related field
- Graduate degree (Master’s or Ph.D.) in Toxicology
- Advanced English proficiency
- Knowledge of conducting toxicological risk assessments for impurities, degradation products, contaminants, related substances, and nitrosamines in accordance with national and international regulatory guidelines (ICH M7, Q3A, Q3B, EMA, FDA, and ANVISA)
- Experience with Read-Across, Weight of Evidence (WoE), QSAR, and mutagenicity/genotoxicity assessment approaches, as well as defining PDE, AI, TTC, and other risk-based exposure limits
- Preferred: experience participating in pharmaceutical industry projects involving cross-functional collaboration with different departments
- Preferred: experience interacting with regulatory agencies and supporting national and/or international marketing authorization applications
- Preferred: knowledge of in silico prediction software
Benefits
Comp & perks- Medical and dental insurance
- Aché and Biosintética medications provided at no cost to you and your eligible dependents
- Preventive examinations with no co-payments
- On-site medical consultations and laboratory sample collection*
- Wellhub (formerly Gympass)
- “Estar Bem Aché” is our integrated health program, designed to support the mental, physical, social, financial, occupational, and intellectual well-being of employees and their eligible dependents
- Support programs for pregnant employees and pregnant or postpartum spouses
- Partnerships and agreements offering educational scholarships and discounts at various institutions
- Profit-Sharing Program (PPR)
- Private pension plan (1:1 employer matching)
- On-site restaurant and meal voucher
- Transportation voucher, parking, or company shuttle*
- Childcare allowance or exclusive daycare facility at the Guarulhos site
- Short Friday exclusively at the Guarulhos site for administrative positions
- Christmas gift