Large Molecule Bioanalysis Scientist
US-OH-Cincinnati
US Careers
Req #: 11299
Type: Full-Time
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Overview: Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries. Responsibilities: * Develop and validate ligand binding assay (LBA) methods for large molecule biologics; * Draft study protocols/plans, acquisition methods, and study reports; * Supervise all phases of bioassays to support human pharmacokinetics, PD Biomarkers and Immunogenicity studies; * Supervise technicians for performing method development, validation, and sample analysis; * Communicate with internal and external resources for sample receiving, quality control, quality assurance, sponsor correspondence etc. Qualifications: * PhD in Cell or Molecular Biology, Immunology, Biochemistry, or related field; or Master degree with at least 5 years related industry experience; * Previous experience with large molecule biomarker analysis (such as proteins, DNAs, and miRNA, etc.); * Strong project management, compliance, communication, and people skills; * Experience with monoclonal antibody (mAb) and antibody drug conjugates (ADC) PK analysis, anti-drug-antibody (ADA) and neutralizing antibody (NAb) analysis; * Experience with ligand-binding assays such as ELISA, ECL, Flow Cytometry, real time-PCR,etc.; * Direct working experience in Good Laboratory Practices is preferred.
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