Analytical Development Chemist

Description

Job Summary: Develop, optimize, and validate analytical methods for raw materials, products under development, and finished products, ensuring reliability and regulatory compliance. Key Highlights: 1. Design and development of innovative analytical methodologies. 2. Leadership in investigation of out-of-specification (OOS/OOT) results. 3. Advanced handling of high-resolution analytical instrumentation. Analytical Development Chemist **Job Objective** Develop, optimize, and validate analytical methods applicable to raw materials, products under development, finished products, and stability studies, ensuring result reliability under strict compliance with current health regulations and Good Laboratory Practices. **Main Responsibilities** * **Development and Optimization:** Design and develop innovative and efficient analytical methodologies for the analysis of new products, formulations, and raw materials. * **Method Validation:** Prepare and execute validation/transfer protocols and reports for analytical methods (Chromatography, Dissolution, Spectrophotometry) in accordance with health regulations. * **Specialized Analysis and Testing:** Perform complex chemical and physical analyses for dissolution profiles, stability studies, related substances, and degradation products. * **Technical Documentation:** Draft analytical monographs, standard operating procedures (SOPs), and required technical documentation for health registration dossiers. * **Out-of-Specification Result Investigation:** Lead technical investigations of out-of-specification (OOS) or out-of-trend (OOT) results in the laboratory, applying root cause analysis. **Required Profile** * **Education:** Completed bachelor's degree in Pharmacy and Biochemistry, Food Chemistry, Chemistry, Chemical Engineering, or related field (**degree certificate and professional license mandatory**). * **Experience:** 2–4 years of verifiable experience in analytical development or analytical method validation within the pharmaceutical or medical device industry. * **Required Technical Knowledge:** * Proficient application of **NOM-059-SSA1** (Good Manufacturing Practices) and **NOM-073-SSA1** (Stability Studies), as well as ICH guidelines. * Advanced handling of high-resolution analytical instrumentation: **HPLC / UPLC** (with various detectors), GC, UV-Vis, IR, and automated dissolution systems. * Solid understanding of Good Laboratory Practice (GLP) and Good Documentation Practice (GDP) guidelines. **We Offer** * Competitive base salary (to be agreed upon based on experience). * Statutory benefits. * Punctuality bonus. * **Work location:** Azcapotzalco, CDMX. * **Schedule:** Monday to Friday. Salary: Starting at $19,000.00 per month Workplace: On-site employment