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We are looking to fill a Bioanalytical Scientist position working as a full-time employee of Parexel FSP on long-term assignment onsite at one of our clients located in West Point, PA. Description Our client's Department of Pharmacokinetics, Dynamics, Metabolism, and Bioanalytics (PDMB) is seeking a bioanalytical scientist to work with its Regulated Pharmacokinetics (PK) & ADA (Anti-Drug Antibody) Bioanalytical group located in West Point, PA. In this position, you will be responsible for developing bioanalytical methods for measuring biotherapeutics, such as monoclonal antibodies, proteins, and antibody-drug conjugates and assessing their immunogenicity in support of Good Laboratory Practice (GLP) and clinical studies. Responsibilities
Conduct bioanalytical work to a high degree of quality and rigor, ensuring compliance with regulatory guidelines Develop 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 technologies Contribute to immunogenicity assay development, qualification/validation and sample analysis, in support of preclinical and clinical studies Generate quality data in support of preclinical and clinical studies Communicate results effectively Contribute to authoring of method development reports, test methods, qualification and validation reports, and study reports
Qualifications Scientist 3
B.A./B.S. in Biology, Immunology, Molecular Biology, Chemistry, Biochemistry, Pharmaceutical Sciences, or related discipline with 3 - 5 years of relevant experience
Senior Scientist 1
B.A./B.S. in Biology, Immunology, Molecular Biology, Chemistry, Biochemistry, Pharmaceutical Sciences, or related discipline with 5+ years of relevant experience Master's Degree in Biology, Immunology, Molecular Biology, Chemistry, Biochemistry, Pharmaceutical Sciences, or related discipline with 1+ years of experience
Required Skills and Experience
Knowledge of the basic principles of regulated bioanalysis and Good Laboratory Practice (GLP) Good verbal and written communication skills Ability to follow procedures and thoroughly document experiments
Desired Skills and Experience
Processing biological samples for further analysis and characterization Use of automation platforms to perform preclinical and clinical assays GxP as it applies to regulated bioanalysis Use of electronic laboratory notebooks Developing ligand binding assays and/or LC-MS assays in support of regulated (GLP and clinical) pharmacokinetic and immunogenicity studies for biological drug development candidates
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Parexel International Corporation
Jan 12, 2025