• build and foster strong collaborative partnerships with CDMOs for drug substance process development, characterization and technology transfer activities • aid in developing robust drug substance manufacturing processes throughout the product life cycle for Akero products • ensure successful, right first time, transfer of process technologies to CDMOs and from one CDMO to another as required • ensure process development studies are conducted under approaches that are reflective of regulatory guidance and agency expectations and utilizing statistical and characterization methods that are appropriate for late-stage process development • review and approve DS related manufacturing documents, i.e. master batch records, change controls, plans, protocols, reports, and deviations as required • support process trending analysis for existing and next-generation manufacturing processes, tying process development knowledge and experience to GMP manufacturing performance • conduct CDMO site visits as required to support process development and technology transfer, conduct routine technical meetings with key stakeholders to coordinate development efforts and collaborate with partnering teams • author and/or review process development global health authority dossier sections for clinical trials and commercial licensure • interface with quality assurance to establish and maintain drug substance related procedural documents