Job Summary: Analytical Development Professional responsible for developing and validating methodologies, conducting stability studies and dissolution profiles, and providing technical support. Key Highlights: 1. Brazilian company with international presence and innovation embedded in its DNA 2. Values inclusion and diversity across all positions 3. Opportunity to work on the development and validation of analytical methodologies We are a Brazilian company with international presence, bringing innovation into our DNA! At Biolab, we believe diverse teams build stronger and more transformative results. **We value inclusion and diversity in all our positions**. Therefore, we encourage applications from people with disabilities and individuals of all identities, backgrounds, and origins**.** In the Analytical Development team, you will be responsible for developing and validating analytical methodologies for finished products, raw materials, cleaning, and processes. You will conduct stability studies, evaluate dissolution profiles, and qualify new raw material suppliers. You will also provide technical support to other departments, ensuring quality, regulatory compliance, and robustness of analytical processes. **WHAT WE EXPECT FROM YOU:** * Bachelor's degree in Pharmacy or Chemistry * Availability for a fully on-site work model (Itapecerica) * Strong communication skills, interpersonal relationship abilities, and problem-solving capability * Knowledge of Liquid and Gas Chromatography, ICP (desirable), GLP, RDC 31/10; RDC 53/15; RDC 73/16; RDC 166/17; RDC 318/19 * Second-shift work schedule. **MAIN RESPONSIBILITIES FOR THIS POSITION:** * Perform analytical validation analyses on products and raw materials, following guidance from senior/lead analysts and coordination. * Conduct forced degradation studies and dissolution profile evaluations, including preparation of protocols and reports according to RDC 31 and RDC 53 (ANVISA). * Develop, validate, and transfer analytical methods for products, raw materials, and cleaning. * Prepare and review technical documents, such as: certificates of analysis, analytical methods, SOPs, calculation sheets, protocols, and technical reports. * Perform statistical and trend analyses for stability studies. * Prepare solutions, reagents, and materials required for routine analytical activities. * Manage, incubate, and monitor samples in stability chambers. * Open, track, and resolve analytical deviations, CAPAs, and NCs, supporting implementation of corrective actions. * Support qualification, calibration, and verification processes of laboratory equipment. * Ensure laboratory organization, material expiry control, and maintenance of appropriate equipment and environmental conditions. * Comply with quality, safety, environmental, and good laboratory practice standards. * Support procurement processes, follow-up on reagents, standards, and supplies, as well as invoice entry and tracking in the system. * Provide technical support to pharmaceutical technology development and technical documentation departments. * Guide junior analysts, assistants, aides, and interns in performing laboratory activities. * Participate in regulatory inspections and audits alongside coordination and management. **Location****Employment Type****Work Model** Itapecerica da Serra, SP, BR Permanent CLT On-site
João Silva
Indeed · HR
João Silva
Indeed · HR
