About the Position Job Description The Opportunity This exciting role, based within the Research & Clinical Bioanalytics Department, will be bench based, utilising the successful applicants experience and expertise to lead activities in identifying, establishing, developing and implementing specialised (non - routine) bioassays (eg PK, immunogenicity/anti - drug antibody and mechanistic/PD biomarkers) to support Research & Development of novel therapeutic proteins. The successful applicant will join a research focussed, high profile, laboratory based team, that works at the interface between research and clinical development, devising, developing and implementing high quality, regulatory compliant bioassays and biomarkers to support R&D of candidate therapeutic proteins and provide data from such assays to allow scientifically informed go/no go decisions in research, toxicology and early clinical development studies. You will be defining standard operating procedures governing assay conduct to support pre - clinical, GLP toxicology and clinical development studies. You will also need to maintain a high level awareness of key scientific/technical strategies and innovative technical developments in your areas of expertise You will be an expert with In vitro assay methodologies (e. g. ligand binding technologies/assays) Flow Cytometry Immunohistochemistry PCR techniques Transcript profiling Western blotting Cell - based bioassays [cell signalling, receptor/binding occupancy, cytotoxicity etc.] Chemokine/cytokine biology, Immune cell analysis and assay Inflammatory assays In and ex vivo assay methodologies using animals or humans to develop/refine models that allow Measurement of PK of therapeutic proteinsMeasurement of immunogenicity of therapeutic proteinsMeasurement of dynamic modulation of target mechanism/biology (i. e. development of pharmacokinetic/pharmacodynamic models)Demonstration of the relationship btw biomarker modulation and outcome A particular focus of the role will be on the development, validation and clinical implementation of bioassays and biomarkers that will support First in Human clinical studies of CSL s pipeline of novel recombinant molecules (antibodies and coagulation factors). To be successful You will hold a post - graduate qualification with at least 3 years experience in pre - clinical and clinical development of biopharmaceuticals or equivalent related experience in industry and/or academia. You will lead the science from the bench for the development of relevant new assays. You will also assess all aspects of the feasibility of such bioassays or biomarkers for inclusion in research, GLP toxicology and clinical studies (e. g. reagent provision, assay design and robustness, compliance to appropriate regulatory standards (eg GMP, GLP and GCLP), sample collection, transport logistics and clinical practice). The successful applicant will have excellent communication/networking skills and require close liaison (inc Tech/Knowledge Transfer) with our research colleagues within Bio21, with the Clinical Pharmacology and Translational Development group and across the different global CSL research sites (Marburg, Bern). You will establish/adapt assay methods whilst verifying/validating that assays are fit for purpose . An excellent problem solver with practical application to lab techniques and instrumentation, you will be a self starter and undertake novel approaches to basic scientific questions. Applications close Friday, September 21st, 2018 Employment screening, including criminal history, medical assessment, confirmation of experience and stated qualifications, Australian working rights and other relevant checks form part of the candidate suitability evaluation process. Other information Company CSL Behring no - Principals only. Recruiters, please don t contact this job advertiser. no - Please, no phone calls about this job! no - Reposting this message elsewhere is NOT OK.

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Research Scientist - Assay Innovation & Clinical Translation -

By Bobby 0 0 117
3 years ago
Melbourne Melbourne, Victoria, Australia


Last seen:  3 years ago