Scientist III or Senior Scientist I - Bioanalytical Preclinical Development

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