Research Scientist is responsible for comprehensive product development activities of injectable and dermatological products from concept to scale-up. This includes analytical development and validation of analytical methods.
Research Scientist oversees the design and initiates formulation and process development. He/she compiles, maintains, critically evaluates and interprets experimental data for conclusions and resolution of problems. Research Scientist provides suggestions and problem resolution based on technical expertise. Research Scientist conducts/guides physico-chemical characterization and pre-formulation studies to investigate chemical compatibility, degradation pathways, physical attributes, and the targeted product profile.
Research Scientist works in a regulated environment (cGMP), follows Standard Operating Procedures and all applicable compendial, ICH and regulatory guidelines. For everyday work he/she uses HPLC/UPLC with UV/PDA/RI detectors; HS-GC-FID; Karl Fischer and other titration techniques; API supplier DMF-s (drug master files), US and European Pharmacopeia, ICH and FDA guidelines, scientific literature.
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