Design, review, and recommend changes to scientific protocols and procedures for aseptic processing and sterile manufacturing. * Perform data analysis, present results, and troubleshoot issues related to parenteral formulation stability, sterility, and manufacturing processes. 3 years of demonstrated expertise in formulation development of parenteral dosage forms, process scale-up, and a strong working knowledge of cGMP for sterile product manufacturing and quality control. * Understanding and strong working knowledge of GMP and industry/global regulatory guidelines, such as VICH and ICH, specifically pertaining to sterile product manufacturing and quality control. * Ability to work effectively and flexibly within and across Elanco R&D teams, manufacturing, and external collaborators.
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