Must have experience with the following in order to complete the abovementioned tasks Management Build and maintain partnerships with all functions to ensure technology team members understand business needs, functional specifications; Domain Assessment and Reporting of the Clinical Immunogenicity, bioanalytical method development and validation;br Knowledge of regulatory e.g. FDA requirements for validation and reporting of ADAPK assay results; Statistics Data analytics Verify the sanctity of statistical analysis techniques and principles used during product development including distributions, inferences, outlier detection, analysis of variance and design of experiment; Proficient in working with technologies related to artificial intelligence, machine learning andor deep learning; Tensorflow; python; AWS; AngularJS; Computer Vision; Natural Language Processing; Proficiency in data visualization, natural language processing and image processing. Software architecture Experience ensuring that best development processes and technologies are used in the design,br construction and implementation of applications; Experience working on SaaS application model in AWS with Security, Scalability, Availability and Monitoring; Software validation and regulatory compliance Knowledge of GAMP5, 21 CFR Part 11 , ISO 27001 and SOC2 controls; GDPR and GxP guidelines for software applications; ToolsTechnical skill Angular 7 orbr above, AWS Lambda, API Gateway, Cognito, CloudFormation SAM, AWS Step functions, DynamoDB, S3, ECS, CLI, KMS, Python APIs Scikitlearn, Open CV, Tensorflow, Boto3, Tabula, PyMuPDF, PythonDocx Pandas and Numpy, and Docker creation and deployment. Option to work from home may be available.
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