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Represent Drug Product team in CM&C teams and support the formulation and process development of protein, peptide, oligonucleotides and other novel modalities in clinical development.
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Comprehensive knowledge and understanding of (1) traditional and new modalities of parenteral drug product development (2) parenteral manufacturing and aseptic technologies, and drug product process development.
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We are a market leader in automated bio sample management solutions and genomic services across areas such as drug development, clinical and advanced cell therapies for the industry's top pharmaceutical, biotech, academic and healthcare institutions globally.
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Empower, delegate and develop talent in consideration of business and development needs both locally and globally. The Director of Biorepository Operations provides direct, hands-on leadership of all sample management, logistics and training functions at the Indianapolis location.
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You will be responsible for building and leading a multi-functional IT department in support of digital strategy & delivery for clinical development and the commercialization of isotope and radiopharmaceutical drug products.
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Lead the preparation of regulatory communication and documents to support clinical development (IND), new drug applications (NDA) and BLA and line extensions and interact with regulatory agencies worldwide.
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Employees may elect medical, prescription drug, dental and/or vision coverage for you and your family in one of two health plan options, enjoy best-in-class mental health support, and concierge services for orthopedic, cardiovascular, fertility care, and LGBTQ health navigation.
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7+ years of experience in several of the following disciplines: statistical methods, data modeling, ontology development, semantic graph construction and/or linked data, relational schema design.
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Experience applying GxP requirements to the conduct of drug development. The Quality Associate Director Regulatory Intelligence monitors the environment for regulatory compliance intelligence in the company's areas of interest to ensure that current awareness is maintained across the organization and, where necessary, that company procedures are introduced or adapted to respond to changes in the regulatory environment.
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