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 LC-MS/MS, GC-MS, ICP-MS, HPLC methods for small molecule drugs or drug metabolites and biomarkers;
* Draft study protocols/plans, acquisition methods, and study reports;
* Supervise all phases of bioassays to support pre-clinical and clinical pharmacokinetics, PD Biomarkers;
* 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 Chemistry, Biochemistry, Pharmaceutical Sciences or related field; or Master degree with at least 5 years related industry experience;
* Previous experience with small molecule drug and drug metabolites analysis;
* Strong project management, compliance, communication, and people skills;
* Experience with various extraction procedures, such as LLE, SPE, SLE+, immune-capture hybrid extraction, etc.;
* Experience with LC-MS/MS, GC-MS, ICP-MS, HPLC, etc.;
* Direct working experience in Good Laboratory Practices is preferred.
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