Job Title

Job Summary: We are seeking a highly skilled and experienced professional to lead our Analytical Research & Development (ARD) team. The ideal candidate will oversee the development, validation, and transfer of analytical methods, ensure regulatory compliance, and manage ARD operations in coordination with cross-functional teams. This role involves comprehensive review responsibilities, training, project planning, and handling of regulatory and quality management systems.Key Responsibilities: Lead and manage the ARD team in day-to-day operations. Evaluate Drug Master Files (DMFs) and provide technical assessments. Oversee analytical method development; review related data including protocols, reports, and Laboratory Notebooks (LNBs). Execute and review analytical method validation for drug substances and drug products. Review and ensure compliance with Standard Operating Procedures (SOPs). Conduct and review analytical method transfers and verifications. Review all data generated within the ARD. Execute and review analytical method equivalency studies. Review and approve STPs (Standard Testing Procedures) and specifications. Establish and finalize specifications for drug substances and products. Handle and respond to regulatory queries in a timely manner. Review investigations and manage Change Control (CC) activities. Coordinate with cross-functional departments to ensure seamless project execution. Plan and conduct training and qualification for ARD personnel. Oversee in-use stability method development and validation activities. Conduct pharmaceutical equivalency studies. Plan and review ARD work allocations. Manage qualification of analytical instruments. Oversee procurement of project-specific analytical attributes. Manage software systems including e-DCS, LMS, e-Log, ERP, LIMS, and CLEEN. Investigate and manage Quality Management System (QMS) elements such as OOS (Out of Specification), OOT (Out of Trend), CC, CAPA, deviations, and incidents. Ensure adherence to Good Laboratory Practices (GLP) and Good Documentation Practices (GDP). Review periodic calibration records for all instruments. Monitor and review laboratory logbooks and records. Review User Requirement Specifications (URS) for analytical instruments. Lead CMC studies including photostability, thermal cycling, temperature excursion, and diluent studies; plan and review related protocols and reports. Execute and review analytical cleaning method validation. Participate in audit preparation and handle audit-related activities. Conduct validation using advanced analytical techniques such as ICP-MS, Malvern particle size analysis, and dissolution profiling. Conduct and support diluent studies, CMC studies, and scale-up analysis.Qualifications and Skills: Master's in Analytical Chemistry, Pharmaceutical Sciences, or a related field. Minimum 15 years of relevant experience in ARD within a pharma. Strong knowledge of ICH guidelines, regulatory requirements, and industry best practices. Hands-on experience with analytical instruments (e.g., HPLC, GC, ICP-MS, Malvern, dissolution). Proficiency in QMS systems and analytical software tools. Excellent communication, leadership, and organizational skills.