Description: Professional responsible for developing and interpreting forced degradation studies and preparing technical-scientific reports related to active pharmaceutical ingredients (APIs) and finished products, with a focus on degradation pathways, reaction mechanisms, and regulatory compliance (RDC 53/2015 and Guideline No. 4/2015 – ANVISA). Responsibilities and Duties: * Preparation of technical-scientific reports containing the theoretical rationale for possible degradation pathways of APIs, potential interactions with excipients, and correlation with the finished product, in accordance with RDC 53/2015 and ANVISA Guideline No. 4/2015. * Technical support in conducting forced degradation assays, including experimental design, assay monitoring, and analysis of results. * Interpretation of analytical data, discussion of degradation pathways, identification of mechanisms of involved reactions, and performance of mass balance. * Identification and quantification of potential degradation products/impurities using chromatographic and spectrometric techniques. * Collaborative work with researchers and managers in evaluating and preparing responses to regulatory requirements related to degradation studies and mass balance. Requirements and Qualifications: * Education: Bachelor’s degree in Chemistry, Pharmacy, Chemical Engineering, Pharmaceutical Sciences, or related field. Postgraduate qualification (Master’s/PhD) is desirable. * Required technical experience: proven experience in forced degradation and accelerated stability studies, including interpretation of results and preparation of technical-scientific reports. * Analytical knowledge: proficiency in techniques such as HPLC/UPLC, LC-MS(/MS), and knowledge of method validation and impurity quantification. * Regulatory knowledge: familiarity with RDC 53/2015 and ANVISA Guideline No. 4/2015, and related requirements for degradation studies and mass balance. * Preferred qualifications: experience in the pharmaceutical industry, history of responding to regulatory requests, proficiency in analytical data processing software, and experience in structural elucidation of degradants. Additional Information: Company focused on quality and regulatory compliance, with a collaborative environment among R&D, Quality Assurance, and Regulatory Affairs teams. We offer opportunities for technical and scientific development, market-competitive remuneration, and a comprehensive benefits package. Work location and model (on-site/hybrid) are subject to company policy. ]]> 2512200202551804448