Scientist III or Senior Scientist I

6 days ago

King Of Prussia, United States Parexel International Corporation Full time

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

RequiredPreferredJob Industries
  • Other

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