Principal Scientist II

Description

We are seeking a highly motivated individual to join our highly innovative and multidisciplinary cell line development team to support biologics drug development. The candidate must have a core expertise in high-throughput screening, and solid experience with multi-color flow cytometry analysis. The primary responsibility for this position will be to perform routine flow cytometry assays, cell sorting, and high-throughput screening. The candidate is expected to work independently to execute experiments, process large data sets, and basic data analysis. Other responsibilities include efficient communication of results and proposing next steps to team members.

Responsibilities

Basic principles of regulated bioanalysis and Good Laboratory Practice (GLP)Processing biological samples for further analysis and characterizationUtilizing automation platforms to perform preclinical and clinical assaysGxP principles as applied to regulated bioanalysisUse of electronic laboratory notebooks (ELN)Developing ligand binding assays and/or liquid chromatography-mass spectrometry (LC-MS) assays in support of regulated (GLP and clinical) pharmacokinetic and immunogenicity studies for biological drug development candidatesQualificationsPhD in Immunology or related Biological Sciences with at least 1 years of cell line development experience in industry.Or MS in Molecular Biology, Biochemistry, or related Biological Sciences with at least 2 years of multi-color flow cytometry assays experience in industry.Required Skills and ExperienceConducts bioanalytical work to a high degree of quality and rigor, ensuring compliance with regulatory guidelinesDevelops regulated bioanalytical methods for the quantitation of biotherapeutic drug candidates using ligand binding assay-based platforms such as Meso-Scale Discovery, Gyrolab, Ella, and other emerging technologiesContributes to immunogenicity assay development, method qualification, method validation, and sample analysis, in support of preclinical and clinical studiesGenerates quality data in support of preclinical and clinical studiesContributes to authoring of method development reports, test methods,method qualification and method validation reports, and study reportsMaintains accurate documentation and recordsDesired Skills and ExperienceGood verbal and written communication skillsAbility to follow procedures and thoroughly document experimentsCommunicate results effectivelyProficiency with written and spoken English is requiredAbout Parexel Parexel FSP includes the CMC Operations group. We provide pharmaceutical and biopharmaceutical companies with qualified and talented technical professionals to support the development and delivery of new therapies. For results-driven and caring individuals who want to make a meaningful difference in the world, Parexel is trusted by life sciences companies to meet their long-term staffing needs for scientists and engineers and related professionals in discovery and development of novel therapies, keeping patients at the center of everything we do, and where an inclusive community helps you be your best, transforming any career into a life-changing achievement. Come join us

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