Analytical Research and Development Manager

Job description

Roles and Responsibilities : • Method Development & Validation: Lead the design, optimization, and validation of stability-indicating analytical methods (HPLC, UPLC, GC, LC-MS, Dissolution) for drug substances or products or technicals. • Troubleshooting & Investigation: Resolve complex chromatographic or instrumental issues, handle Out-Of-Specification (OOS) or Out-Of-Trend (OOT) results, and draft robust CAPA plans. • Documentation & Compliance: Author, review, and approve critical technical documents, validation protocols, standard operating procedures (SOPs), and STPs in alignment with global regulatory standards (USFDA, ICH, GLP). Fair knowledge in NABL documentation and audits. • Technology Transfer: Coordinate seamless method transfers to Quality Control (QC) or manufacturing plant sites. • Validation & Verification: Validate methods for active content, impurity profiling, storage stability, and physical-chemical properties. • Regulatory Compliance: Ensure all laboratory data aligns with OECD-GLP, CIPAC, SANTE, and country-specific registration guidelines (e.g., CIB&RC, EPA). • Impurity Profiling: Identify and quantify unknown impurities, degradation products, and 5-batch analysis compounds. Job Requirements : • Technical Mastery: Advanced command over analytical hardware/software (HPLC, GC, UV-Vis, FTIR, NIR, Dissolution, PSD, NMR, PXRD, Ion Chromatography, ICPMS, MS-MS, GCMS, LCMS, Prep-HPLC, UHPLC, AAS, Polarimeter, LAB analysis, Refractometer and other Wet lab analysis) and data integrity rules (ALCOA+). • Domain Knowledge: Lead the development, validation, and execution of advanced analytical methods for agrochemical products. This includes active ingredients (AI), technical-grade materials, and diverse formulations (e.g., EC, SC, GR, WG). Ensure strict compliance with global chemical and agricultural data standards. • Leadership & Mentoring: Guide, train, and oversee junior analysts and execution timelines across cross-functional R&D projects. • Soft Skills: Strong technical writing, cross-functional communication, and project management skills (preferable but not essential).