immediate Need- Analytical R&D- Executive - (Injectables)

Job Description

Role & responsibilities Job description Conduction Literature search on the molecule with respect to compendial methods, monographs and information available in DMF/VMF. Compile the same and share with manager as developmental STP. Thoroughly understands the structural chemistry of molecules and deep dives in the probable degradation mechanisms and share the feedback to the manager with respect to: Instrumentation techniques to be sued for assay and RS method development. Prepare the Analytical testing profile document as per Analytical QbD Prepare Critical method Parameters document as per Analytical QbD Prepare Analytical method development protocol & reports Prepare Analytical method validation protocols and reports Prepare Analytical method transfers protocols and reports Prepare RM, PM, FP Specs and STPs at developmental stage and also for TTD Conduct lab experiments (testing runs) hands-on, with least supervision. Dosage forms experience: Solid Orals & injectables Perform analytical development activities on differentiated formulations and innovative technologies as part of product development. Core Competencies and In depth experience in: HPLC/ UPLC GC, GC-MS, LC-MS Dissolution tests In process tests UV/ Vis Spectrophotometry Optical Microscopy IVRT Carry out routine analysis of formulations and raw materials. Follow good laboratory practices, good documentation practices (LNB writing) and maintain the logbooks and forms for equipment/instruments. Compilation, interpretation and review of analytical results and stability data Maintain records of projects. Exposure in oral liquids and oral solid dosage forms will have an added advantage. Coordinate outsourced activities at the partner site by a regular communication plan. Provide timely technical inputs and timely escalation to ensure successful task completions. Communicate effectively with R&D, production, QA/QC, supply chain teams clients, vendors, and stakeholders regarding project progress and requirements. Qualifications M. Pharm or Ph.D. in Pharmacy, / M. Sc. with minimum industrial experience of 3 to 9 years in pharmaceutical development. Support in Technical troubleshooting/ root cause identification/ Investigation/Corrective Action and Preventive Action pertaining to product development or manufacturing activities.