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Partners with Client GRA CMC (regulatory scientists) develop complex regulatory strategies. Makes technical decisions on CMC regulatory issues impacting product submissions across geographies, with support or guidance from Client GRCMC regulatory scientists.
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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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Due to a strategic commitment to the growth of biotherapeutics within the Lilly portfolio, multiple opportunities are currently available within the Bioproduct Research and Development (BR&D) organization.
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This role will be responsible for leading the day-to-day Quality operations and driving commercialization efforts for current and future clinical programsOversight of the entire Quality organization including Quality Assurance Operations, and Quality Systems and Compliance with oversight over Quality Control and CMC as well as Clinical Quality of clinical trials.
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Responsibilities: In this individual contributor position Global Product Steward scientist role, you will have the opportunity to collaborate with cross functional teams across Lilly and external manufacturing organizations.
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Five or more years of global regulatory CMC experience, or equivalent experience supporting CMC functions contributing to clinical trial phases of development in various regions, including US, EU, and Asia. Or 5 years’ experience in large molecule/biologics research and development or formulation.
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Ensure all MM Data and Panel programing are accurate and place accounts in service to be monitored in the CMC. Ability to perform technical research to resolve complex problems i n DMP panels.
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In this role, you will provide hands-on, day-to-day technical and strategic leadership and work closely with cross functional teams in Analytical Development, Process Development, Global Quality and Regulatory Affairs-CMC, and our partners in in the commercial/manufacturing to support commercialization of our company's large molecule products.
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Successful leadership in delivering CMC sections of marketing authorizations, clinical trial applications (CTA/IND) and post-approval submissions for new biological, oligonucleotide, and/or chemical entities.
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CMC is growing quickly and this is an excellent time to jump on board to make an impact supporting hospitals throughout the country with professional staff. CMC was recently named #219 on the list of Fastest-Growing Health Services companies in the US.
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PhD degree in Chemistry or a relevant discipline with 5+ years of experience (synthesis, oligonucleotide experience, solid phase synthesis, CMC) OR MS degree with 8+ years of relevant experience.
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