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This position reports to the head of clinical pharmacology and toxicology and liaises with clinical development, clinical operations, non-clinical pharmacology and toxicology, and drug discovery to execute activities for advancing the development pipeline.
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Provide front line and independent process development expertise for clinical and commercial drug product manufacturing operations during sterile processing, process characterization, tech transfer, process validation, and on-going commercial manufacturing.
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Founded in 2004, Pharmaron has invested in its people and facilities and established a broad spectrum of research, development, and manufacturing service capabilities throughout the entire drug discovery, preclinical, and clinical development process across multiple therapeutic modalities, including small molecules, biologics, and CGT products.
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It is the division's leader in sterile product and process development, responsible for late-stage commercialization activities including process scale up, technology transfer to internal and external sites, process validation, authoring of regulatory submissions and support of significant manufacturing investigations.
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Determines appropriate assays and vendors for clinical biomarkers, and manages outsourcing of biomarker assay development and validation partnering with Translational Sciences colleagues when applicable.
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Execution and understanding of protocols for protein chemistry and target validation, such as SDS-PAGE, ELISA, western blots. As a research associate you will be part of a diverse team working on in vitro assays and in vivo measurements of drug activity.
$85,000 - $105,000 a yearFull-timeExpandApply NowActive JobUpdated 5 days ago - UpvoteDownvoteShare Job
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Deep understanding of the pre-clinical, translational, and clinical stages of drug development. Extensive working knowledge of biomarker and bioanalytical assay development and cutting-edge Omics methodologies in the clinic.
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Our Pivotal Attribute Sciences Department plays a crucial role in pivotal phase analytical development, including method development, validation, transfer, process and product development support, and GMP testing of drug substances and drug products.
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Enhance statistical expertise in value-based drug development among Pfizer HEOR scientists, statisticians, and clinicians through active engagement and leadership in research methodology and content-specific areas.
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Additionally, you will provide subject matter expertise in some of the areas of toxicology that include fit-for-purpose safety biomarker development and validation, bio-fluid/tissue biomarker analysis, in silico, genetic, endocrine, and reproductive toxicology efforts to support on-going development of preclinical candidates.
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As an SLM Assay Application Service Consultant you will be responsible for : Representing the global service organization on new assay development teams, as well as providing service lifecycle support for IMMULITE immunoassays and Syva drug testing assays in the Specialty Lab Solutions business line.
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The Process Development Associate will help design and perform experiments at the bench scale that span the end-to-end Drug Substance process, covering cell culture and/or purification operations.
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Clear understanding of the drug development process, submission-related activities and regulatory requirements (eg, CDISC, CDASH, eCTD) and guidelines (eg, ICH, CHMP, FDA, GCP). Provide statistical programming and validation support for clinical study reports and help coordinate programming activities with Biometrics lead and other study programmers to meet timelines.
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This person is responsible for the governance of the GMP facility environmental monitoring and contamination control program including the qualification of the GMP facility and maintaining the qualified status, aseptic process simulation, disinfection procedures/practices, disinfectants qualification, cleaning validation, and oversight of microbiological testing of raw materials, intermediates, drug substance, and finished goods.
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Support Drug Safety Pharmacovigilance, Computer System Validation and GLP. Expeirence with drug development process – clinical protocol development, global trial management and monitoring, drug safety, biostatistics and programming and/or data management.
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