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Experience in oncology drug development. Extensive training and experience in the design and conduct of in vitro and in vivo preclinical pharmacology and toxicology studies directed at the development of pharmaceuticals or biologics.
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Senior Director, Drug Substance Position Summary Reporting to the VP, Head of CMC Development, the Senior Director, Drug Substance will be responsible for leading the drug substance team in development and manufacturing as part of PepGen ́s CMC team.
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You will join the Drug Product Development team responsible for formulation and drug product process development, scale-up, and technology transfer for novel viral vectors being developed for in vivo gene therapy.
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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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The Associate Director will perform job duties independently with minimal supervision and/or lead QP2 efforts on drug/vaccine development programs, and author or co-author strategic documents.
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Requires a fundamental understanding of the drug development process and pharmaceutical / biotechnology marketplace, of the preclinical CRO industry, and previous demonstrated experience with SalesForce or a similar Client Relationship Management tool.
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Business Intelligence (BI), Database Design, Data Engineering, Data Modeling, Data Science, Data Visualization, Machine Learning, Project Management, Software Development, Stakeholder Relationship Management.
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Minimum of 10 years of working in clinical research and drug development in the pharmaceutical industry (and/or Contract Research Organizations) with specific experience with TMF, clinical documentation and/or records & information management.
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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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Seeking a Process Development Engineer to join the Drug Substance Technology Engineering team at our Thousand Oaks facility. process development,purification,downstream,cell culture,gmp,biotechnology,pharmaceutical,CAPA,fda.
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Responsibilities:The role will involve leading and carrying out laboratory experiments related to ADC conjugation, associated purification and analytical characterization of the conjugatesDesign, produce, and characterize antibody-drug conjugates (ADCs) with a high degree of independenceProactively advise and share knowledge and expert opinions with bench scientists, peers and senior management.
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Possess a DAU Level II equivalency in Program Management or senior level DoD experience in pharmaceutical/biotechnology vaccine and drug development portfolio management (i.e., investment decisions based on the risk management process.
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Minimum 12 years' experience as a safety physician with the biotechnology / pharmaceutical industry, leading drug safety & pharmacovigilance, including cross-functional team leadership for signal detection, evaluation, risk classification and management, and communication, for products across multiple stages of development.
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Expertise and interest in drug development, preferably in immuno-oncology and/or cell therapies is highly desiredSpecial Skills/Abilities:Understanding of the molecular pathways underlying solid tumorsUnderstanding of drug and biomarker development process from target identification to post marketing approvalUnderstanding of prognostic and predictive biomarkers and personalized healthcare approaches.
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Provides oversight of case processing activities for the Xenon clinical development program and serves as safety data management subject matter expert (SME) on regulations and best practices for conventions and handling of safety data in Xenon’s global safety database (GSDB.
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development management drug jobs Title: development director Company: Omeros
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