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The JPT Associate Director will partner with Lilly’s Process Research & Development group on commercialization (technology transfer, process validation and regulatory approval) of Lilly’s exciting leading pipeline and will be a member of the Flow Team and Extended Site Lead Team within API External Manufacturing (API EM.
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Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities.
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Responsibilities include establishment of, and adherence to, non-clinical study timelines, monitoring of study conduct at the TPO via communication with the Study Director and/or onsite observation, and real time communication with the Toxicology ADME/ToxPath/Drug Disposition (ATP) team throughout study planning, execution and reporting.
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Makes risk-based decisions on CMC regulatory strategies impacting product submissions across geographies and networks for alignment with CMC team members. The regulatory scientist in Global Regulatory Affairs - CMC Biotechnology will leverage CMC technical knowledge and regulatory science expertise to drive regulatory CMC strategies and develop submissions for marketing authorizations for the bioproduct portfolio.
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Prior pharma/biotech or academic experience in rare disease, otology, audiology, gene therapy, cellular therapy, and/or medical device a plus. Akouos is building a leading gene therapy company focused on hearing disorders.
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Collaborate with the KDN Advisory Regional Operations Leaders and Sponsors (Americas, Asia Pacific and EMEA) to maintain alignment of key KDN Advisory activities, inclusive of ongoing improvements to core KDN Advisory processes; oversee the design and launch of KDN Advisory operationalization activities (scoping, reporting, budgeting), working together with other KPMG MF and KPMG International enabling teams.
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