Scientist III or Senior Scientist I - Bioanalytical Preclinical Development

Parexel International Corporation; King of Prussia (Montgomery County); On-site; USD 65,000 - 95,000; Full time

Job summary

An established industry player is seeking a Bioanalytical Scientist to join their dynamic team. This role involves developing innovative bioanalytical methods for biotherapeutics, ensuring compliance with Good Laboratory Practice (GLP) standards. You will contribute to immunogenicity assay development and generate quality data to support preclinical and clinical studies. If you have a passion for bioanalysis and a strong background in relevant scientific disciplines, this is an exciting opportunity to make a significant impact in the field of drug development.

Qualifications

• 3-5 years of experience in bioanalytical science for Scientist 3 position.
• 5+ years of experience or a Master's degree for Senior Scientist 1 position.

Responsibilities

• Conduct bioanalytical work ensuring compliance with regulatory guidelines.
• Develop bioanalytical methods for quantifying biotherapeutic drug candidates.

Skills

Bioanalytical methods development

Good Laboratory Practice (GLP)

Communication skills

Ligand binding assays

Education

B.A./B.S. in Biology or related discipline

Master's Degree in Biology or related discipline

Tools

Meso-Scale Discovery

Gyrolab

Ella

Electronic laboratory notebooks

Job description

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