Senior Scientist - Bioanalytical Strategy
Current• Partner with Clients to develop their late-stage biologics/large molecule therapeutics• Principal Investigator (PI) overseeing scientific strategy and integrity of multiple contracted research projects• Design and develop novel bioanalytical methods and ligand-binding assays supporting Clients’ drug-development needs in the large molecule therapeutics / biologics space• Perform electrochemiluminescence immunoassays (ECLIAs) and conventional ELISAs assessing pharmacokinetics (PK) and immunogenicity (ADA) of antibody (mAb) and peptide therapeutics• Complete regulated (GLP) clinical trial sample analyses, bioanalytical method validations, and method qualifications, as well as troubleshooting existing analytical methods and instrument protocols• Compile, analyze, and review raw scientific data associated with method development and qualification efforts, including technical report writing and presentation in an intelligible format suitable for a professional audience• Handle proprietary research data, critical reagents, and industry trade secrets with appropriately high level of confidentiality, integrity, and ethics• Compliance with applicable regulations (GxP), maintaining proper records in accordance with GDP, standard operating procedures (SOPs) and company policies• Contribute to core research goals, group discussions, and meetings, reflecting expert knowledge to team and Clients• 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• Design and perform biophysical/bioanalytical characterization techniques• Computer software skills including: - Microsoft Office 365 Suite (SharePoint, Teams, Outlook, Excel, Word, PowerPoint, and Authenticator) - Salesforce - Lockbox LIMS
