ED11406 Senior Scientist ARD

We are seeking a highly motivated and innovative Analytical R&D Scientist to join our analytical research & development team. The successful candidate will contribute to the analytical method development for formulation, and analytical support optimization of drug products, with a focus on robust analytical methods, quality, technology transfer, and regulatory compliance. This role offers the opportunity to work in a collaborative environment with cross-functional teams including Formulation, Regulatory, QC, Quality, Manufacturing, and Business Development. 1.Support for analytical method development and R&D batches stability for drug formulations for Global Regulated markets (Nasal – Solution, Spray, DPI, pMDI etc.) 2.Perform analytical method development with AQbD, formulation screening, finished product testing, stability study, compatibility studies, RLD reverse engineering, technical transfer, and laboratory-related work during the development stage. 3.Support ANDA submission and complete drug development lifecycle management. Knowledge about analytical methods for pMDI, DPI and nasal spray for US and EU markets. He should be well versed with techniques as, HPLC, Next generation impactor, DUSA, APSD, Plume geometry, breathing simulators, Malvern Mastersizer, MDRS, LCMS for Nitrosamine, Dissolution and related techniques. 4.Perform literature search, patent landscape review, and regulation comparison. Review guidelines and API vendor DMF. Read the pharmacopeias and technical documents to understand the latest knowledge of the OINDP pharmaceutical industry. 5.Participate in Analytical methods Technology transfer to GMP labs to support for manufacture pilot, scale up, submission & commercial batches. 6.Adequately utilize and maintain analytical instruments/equipment. Diagnose and identify solutions to resolve analytical instrument issues. Perform calibration, qualification, and preventive maintenance. Support for procurement and qualification of new analytical instruments/software 7.Review the documents and electronic records. Prepare analytical protocols, reports and CMC documents. Monitor data trending and support for deficiency letter response. Ensure good documentation practices and data integrity. 8.Execute CCR, deviation investigation, CAPA, LIR, SOP preparation, internal and support GMP inspection. 9.Train and mentor analysts in day-to-day laboratory operations. Support relevant departments and customers to complete projects on time. Ensure all activities and analysis comply with applicable GMP, correct procedures, regulatory guidelines, and health and safety regulations 10.Responsible for managing monographs, validated excel sheets, approved reports (paper and electronic), notebooks and document archival 11.Support laboratory management work, e.g., reference/working standard management, instrument management, work area cleaning, reagents and solvents, and other supporting systems 12.Prepare technical documents, as per ICH requirements for analytical method development, protocols and reports. 13.Prepare regulatory submission documents as pe ICH including chemistry manufacturing & controls (CMC), method development report etc. 14.Stay updated with scientific & global regulatory advancements and ensure knowledge sharing with co-workers 15.Collaborate with cross-functional teams on project timelines and deliverables.