Sr. Scientist - BioPharma LBA

Job description

Performing critical work that impacts our industry and our world’s health while problem solving and innovating in the field – that is what Sr. Scientists at KCAS Bio get to do every day. If that gets you excited too, then maybe working as a Sr. Scientist at KCAS Bio is the role for you. When you work as a Sr. Scientist in the BioPharma Sciences group at KCAS, you get to further our mission by leveraging your knowledge in bioanalytical and scientific principles to be responsible for carrying out all aspects of a study, from study setup through reporting, as well as development. You will also utilize your strong base in scientific principles/theories to assess data integrity and troubleshoot when necessary. Our BioPharma Sciences team uses ligand binding assay (LBA) platforms to conduct bioanalytical testing in support of drug discovery, preclinical, and clinical studies, including the quantification of proteins, biomarkers, and anti-drug antibodies in biological matrices using technologies such as ELISA, MSD, and other immunoassay-based methods. ### In this role, we will rely on you to: - Design and execute all phases of assigned projects including assay development, qualification/validation, troubleshooting, data analysis, and report generation - Act as lead scientist, help to design experiments, provide work instructions and technical training to more junior scientific staff in daily activities - Be responsible for all client communication related to study conduct - Interact with QAU to resolve identified audit issues and be accountable for continuous quality management in assigned studies - Have final authority for sample identification, including clinical site discrepancies and/or client - Be responsible for timeline adherence and communication of status to management as required - Ensure compliance of study activities with pertinent portions of study protocol, SOPs and GLP regulatory requirements - Prepare data summaries and final reports for client delivery - Act as a technical expert for assay performance, troubleshooting, and problem solving - Perform all aspects of the job in a way that supports company brand and supports company mission, vision, and values ### To qualify for this role, you will have: - Bachelor’s, Master’s, or PhD in Biology, Biochemistry, Immunology, or related field with at least 5 years of experience in a bioanalytical laboratory environment - Extensive hands-on experience working in a GLP-regulated laboratory environment (required) - Strong experience with ligand binding assays (LBA), including ELISA, MSD, or similar immunoassay platforms - Experience with assay development, qualification, and validation for biomarker, PK, and/or immunogenicity (ADA) assays - Strong understanding of assay performance characteristics (precision, accuracy, sensitivity, selectivity, robustness) - Experience troubleshooting complex assay performance issues and optimizing assay conditions - Experience interacting with Quality Assurance and supporting audits and inspections - Prior experience acting in a study lead or Principal Investigator–type role is preferred