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Extensive experience in late phase drug product development and commercial development with CMC regulatory filings for US (NDA), Europe (MAA), Japan, and China. Playing a critical role as the subject matter expert (SME) and project lead of Pharmaceutical Development within CMC function, the position will be responsible for preformulation studies, formulation and process development, drug delivery design, optimization, scale-up and manufacturing in support of Revolution Medicines pipeline compound development and clinical programs.
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Strong understanding of science and drug development, with specific expertise in nonclinical study design, preclinical CROs, data management systems, nonclinical study procedures, and statistical analysis methods.
$265,000 - $300,000 a yearFull-timeExpandUpdated Today - UpvoteDownvoteShare Job
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Strengthen internal gene therapy CMC capability and serve as regulatory subject matter expert and influential leader within the R&D organization to contribute to drug development at Adverum for its development programs.
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You will champion model-based drug discovery and development and serve as a clinical pharmacology specialist to cross-functional partners. EXAMPLE RESPONSIBILITIES: As a member of a drug development team, routinely provides input into product development strategies and/or research or clinical development plans for assigned products / projects.
$205,700 - $266,200Full-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Extensive experience in late phase innovative drug development and commercial launch with global CMC regulatory filings (IND/NDA/MAA, etc.) Thorough understanding and working experience of innovative drug development and manufacturing with respect to GMP, quality systems, ICH guidelines, FDA, EMA and associated regulatory requirements.
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The Senior Scientist, Formulation Development will assume the critical role of overseeing and executing investigations while developing and deploying strategies aimed at resolving a range of product-related challenges, extending from the initial stages to the more advanced phases of drug product development.
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Experience with strategic and tactical planning for pipeline and marketed product, including expertise and knowledge of the unique aspects of oncology drug development and commercialization.
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Broad understanding of functional areas of drug development, including preclinical, regulatory, pharmacovigilance, drug supply, data sciences (data management, biostatistics, programming), and clinical operations (including site selection, study start-up, study conduct, and finalization.
$190,000 - $260,000 a yearFull-timeExpandApply NowActive JobUpdated 8 days ago - UpvoteDownvoteShare Job
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Performs analytical testing, method development, and bioanalytical characterization of innovative biotherapeutic proteins, including antibodies, bispecific proteins, and antibody drug conjugates.
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Eurest services maintains a drug-free workplace. The Chief Facilities Engineer is responsible for providing assistance in the oversight of business activities, strategic planning and development, and program administration.
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This involves developing lead selection workstreams, overseeing drug mechanism of action (MOA) studies, in vivo pharmacology, and ensuring manufacturing feasibility of development candidates.
$204,000 - $281,000 a yearFull-timeExpandApply NowActive JobUpdated 16 days ago - UpvoteDownvoteShare Job
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We are seeking a Bioinformatics Data Engineer to spearhead the development of an AI-first ecosystem aimed at transforming the drug discovery landscape. A strong passion for using AI to drive innovations in health technology and drug discovery.
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Keen understanding of the drug development process and deliverables at each stage of the pipeline, with a focus on IND enabling studies through clinical proof-of-concept. We combine cutting-edge technologies including optogenetics, in vivo physiology, and spatial transcriptomics to identify novel drug targets and develop effective therapies to address psychiatric symptoms.
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Passion for Innovation: A strong passion for using AI to drive innovations in health technology and drug discovery. Collaborate on Drug Discovery Strategies: Work with interdisciplinary teams to translate experimental data into actionable drug discovery strategies.
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Evaluate and develop the most appropriate biochemical and biophysical characterization tools to support biological drug product development, including adjuvanted vaccine drug products.
$152,000 - $170,000 a yearFull-timeExpandApply NowActive JobUpdated Yesterday
drug development jobs in San Carlos, CA
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