ANALYTICAL DEVELOPMENT SPECIALIST - RAW MATERIAL

Description

Job Summary: We are seeking talented professionals to transform possibilities into reality, contributing to the pharmaceutical company and impacting people's lives so they can live longer and better, with a focus on analytical development of raw materials. Key Highlights: 1. Continuous technical support in Analytical Development of Raw Materials 2. Serve as a technical reference for complex analytical problems 3. Develop robust and stability-indicating analytical methods We seek professionals who can transform possibilities into reality, contribute to maintaining our position as the best and most comprehensive Brazilian pharmaceutical company, and impact people's lives so they can live longer and better. This opportunity is open to all candidates, regardless of sexual orientation, social accessibility, or any other factor. All our positions are open to People with Disabilities (PwD). Don't see yourself reflected in this role? Don't worry! You can still join our team! Register in our talent pool, and as soon as an opportunity arises that better matches your profile, we'll contact you! **Responsibilities and Duties** * Monitor and provide continuous technical support to Analytical Development of Raw Materials (AD/RM) analysts; ensure quality, reliability, and traceability of generated analytical data. Ensure compliance with: pre-established deadlines, internal procedures, and applicable regulatory guidelines (ICH, Pharmacopoeias, ANVISA, FDA, EMA). Serve as a technical reference for resolving complex analytical problems. * Conduct literature reviews using databases, regulatory guidelines, and scientific literature to define the analytical strategy. Prepare and review: analytical development protocols and reports; forced degradation studies; comparative impurity profiles; * Ensure development of robust, stability-indicating analytical methods suitable for: analytical validation, method transfer to other company sites. * Apply advanced knowledge of HPLC, GC, and mass spectrometry. * Provide technical support to the AD/RM team in preparing responses to regulatory requirement notifications; * Contribute technically to: regulatory submissions, maintenance of Drug Master Files (DMFs), drug registration and post-registration activities. Ensure technical alignment among analytical methods, impurity data, and regulatory expectations. * Provide technical support in defining and reviewing specifications for Active Pharmaceutical Ingredients (APIs) and excipients. Ensure harmonization between: manufacturer's Certificate of Analysis (CoA) * Current monographs (USP, EP, JP, FB); evaluate regulatory and analytical impacts of adopted specifications. * Prepare, review, and maintain: Standard Operating Procedures (SOPs), Work Instructions, forms, and technical templates. Ensure standardization of analytical development activities. * Ensure compliance with Good Laboratory Practices and data integrity requirements. **Requirements and Qualifications** * Completed postgraduate degree. * Minimum of 4 years of experience in activities related to analytical method development for raw materials (APIs, excipients), troubleshooting, and analytical validation. * Experience in analytical method development laboratories for raw materials (RM) APIs/excipients. * Experience in development and optimization of analytical methods for organic and inorganic impurities, residual solvents, and elemental impurities; analytical method validation using techniques such as: HPLC, GC-FID, GC-MS, ICP-MS. * Experience in evaluating monographs, DMFs, chemical structure, polymorphism, physicochemical properties, comparative impurity profiles, forced degradation studies, elemental impurities, residual solvents, and supporting justification of organic impurity limits. * In-depth knowledge of regulations and standards related to RM development (ICH Q3A, Q3C, Q3D, Q6A, Q14, M7), pharmacopoeias recognized by ANVISA (USP, EP, JP, FB), and other activities related to the field of expertise. * Knowledge of complementary techniques (Desirable): FTIR, UV-Vis, Karl Fischer titration; DSC, TGA (in interface with Chemical R&D). * Experience with determination of analytical specifications for APIs (ICH Q6A), API quality control strategy; supplier comparability; technical support for supplier qualification; technical justifications for impurities. * Technical English proficiency, at least intermediate level, for researching and reading scientific articles, monographs, DMFs, and others. * Experience responding to regulatory inquiries and requirements. **Additional Information** **Main Benefits:** -------------------------- * Medical assistance; * Dental assistance; * Life insurance; * Meal allowance or cafeteria **(depending on the site)**; * Food allowance; * Transportation allowance, shuttle service, or parking **(depending on the site)**; * Wellhub; * Internal pharmacy — company medications at no cost, extended to spouse and children **(depending on the site)**; * Nova Vida Tem Valor Program (Telemedicine, maternity kit, courses, exemption from co-payment during pregnancy and postpartum, among others); * Health Space — supportive medical care **(depending on the site)**; * PPR / Bonus (depending on the site); * **Tem Valor Club:** E-commerce platform with numerous partner companies offering products and services at exclusive, differentiated discounts; * **Tem Valor Shop** (e-commerce with up to 40% discount on our dermocosmetic and vitamin products); * **Online Psychotherapy**, free and confidential; * **Childcare Assistance** (depending on the site and internal policy); **Note: This opportunity accepts internal applications.** **Published on:** 16/04/2026 **Internal Application Period:** until 23/04/2026