
201 - 500 employees
🏥 Healthcare
🧬 Biotechnology
💊 Pharmaceuticals
💰 $250k Seed Round on 2010-12
Healthcare • Biotechnology • Pharmaceuticals
KCAS Bioanalytical & Biomarker Services is a full-service global bioanalytical Contract Research Organization (CRO) that offers comprehensive GLP/GCP compliant development services. Specializing in bioanalytical and biomarker services, KCAS Bio supports drug development with a range of services including immunogenicity testing, large and small molecule bioanalysis, flow cytometry, and sample management. With over 40 years of experience, the company has contributed to the support of over 300 FDA-approved drugs and developed more than 5,000 assays. KCAS Bio operates globally, with locations in the US, EU, and strategic alliances in Australia, and is recognized for its innovative approach to maintaining seamless operations and minimizing drug development delays. The company’s expertise spans multiple therapeutic areas including oncology, metabolic, infectious diseases, and neurological conditions.
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201 - 500 employees
🏥 Healthcare
🧬 Biotechnology
💊 Pharmaceuticals
💰 $250k Seed Round on 2010-12
Healthcare • Biotechnology • Pharmaceuticals
KCAS Bioanalytical & Biomarker Services is a full-service global bioanalytical Contract Research Organization (CRO) that offers comprehensive GLP/GCP compliant development services. Specializing in bioanalytical and biomarker services, KCAS Bio supports drug development with a range of services including immunogenicity testing, large and small molecule bioanalysis, flow cytometry, and sample management. With over 40 years of experience, the company has contributed to the support of over 300 FDA-approved drugs and developed more than 5,000 assays. KCAS Bio operates globally, with locations in the US, EU, and strategic alliances in Australia, and is recognized for its innovative approach to maintaining seamless operations and minimizing drug development delays. The company’s expertise spans multiple therapeutic areas including oncology, metabolic, infectious diseases, and neurological conditions.
• Execute and oversee all phases of assigned studies, including sample preparation, LC-MS/MS analysis, data review, and report generation in a regulated environment • Act as lead scientist on studies, providing work direction, technical guidance, and training to junior scientific staff • Manage all client communication related to study conduct and data delivery • Interact with QAU to resolve audit findings, deviations, and compliance-related issues • Maintain final authority for sample identification and resolve discrepancies with clinical sites and/or clients • Manage study timelines, deliverables, and status communication to management and clients • Ensure compliance with study protocols, SOPs, and GLP regulatory requirements • Review and ensure data accuracy, completeness, and integrity before reporting • Support audit readiness and participate in client and regulatory inspections as needed • Troubleshoot assay performance and operational challenges within a production environment • Perform duties in support of the company brand, mission, vision, and values • Conduct regulated studies from study setup through reporting • Deliver high-quality results in a GLP-compliant environment • Apply LC-MS/MS techniques and sample preparation methods to bioanalysis for drug discovery, preclinical, and clinical studies, including drugs, metabolites, biomarkers, and active endogenous compounds in biological fluids and tissues
• Bachelor’s, Master’s, or PhD in Chemistry, Biochemistry, 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 bioanalytical sample preparation and quantitative LC-MS/MS workflows • Experience executing regulated studies, including data review, reporting, and audit support • Demonstrated ability to troubleshoot technical and operational issues in a production environment • Experience interacting with Quality Assurance and supporting audits and inspections • Prior experience acting as a study lead or Principal Investigator–type role preferred
• Company sponsored events including food trucks, family days, and spirit days • KCAS University for career growth • Wellness, inclusion, and community outreach initiatives • Stock ownership program • Access to the latest technology • Paid time off to volunteer
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