Senior Scientist - Bioanalytical Method Development
Description
The Senior Scientist - Bioanalytical Method Development is a part of the Assay Development team which designs and executes assays that complement the company's capabilities in custom critical reagents to enable clients to efficiently make data-driven decisions for optimal analytical outcomes to support biotherapeutic drug development. To realize this goal, B2S offers a range of services from drug discovery through nonclinical/clinical development. This includes early phase ADME investigations, reagent optimization, generation of optimal matched pair of antibodies, method qualification, and non-GLP sample analysis.
The Senior Scientist develops, documents, and qualifies large molecule bioanalytical methods including, but not limited to PK/TK, immunogenicity, and biomarker assays to support a range of nonclinical/clinical studies. The Senior Scientist will:
- Design and develop new bioanalytical methods primarily based on ligand binding assays to support the development of large molecule therapeutics.
- Perform a variety of assays including conventional Enzyme Linked Immuno Sorbent Assay (ELISA)/Electrochemiluminescence (ELISA/ECL) immunoassays as well as biophysical/biochemical/bioanalytical characterization techniques including bio-layer interferometry.
- Complete sample analysis and method qualifications.
- Troubleshoot existing analytical methods.
- Review data associated with method investigations, development, and qualification efforts.
- Compile scientific data (including analysis and technical writing) in an intelligible format suitable for a professional audience
- Record and note the experimental processes on time and in a correct documentation format.
- Report and treat data with high level of integrity and ethics.
- Comply with application able regulations (GXP); maintain proper records in accordance with standard operating procedures (SOPs) and policies; independently design and perform scientific experiments with a pre-defined goal including developing new methodologies, protocols, and/or test procedures that contribute to core group research goals and reflect expert knowledge.
- Write, edit, and revise standard operating procedures (SOPs), qualifications, and forms.
- Independently apply basic scientific principles, perform literature searches, attend scientific meetings, and keep up to date on literature in the biotherapeutic bioanalysis field.
- Order laboratory supplies, as needed.
- Maintain laboratory equipment, as needed.
- Perform other duties as assigned.
Requirements
Education and Experience:
The ideal candidate will have a Bachelor’s Degree (B.S.) with at least five-years of direct laboratory experience, or a Master’s Degree (M.S.) in chemistry or a related science with at least three-years of direct laboratory experience. An equivalent combination of related education and required work experience will be considered with management approval.
ELISA/Ligand Binding Assay experience strongly preferred
Incumbent must have the ability to adapt and conform to shifting priorities and demands and execute accordingly. Strong organizational, and communication skills, both written and verbal are required. The position may require some evening and weekend work, domestic travel and a valid driver’s license. Computer software skills required including Microsoft Office Suites.