Central Lab Scientist - Molecular

				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:

* Monitor laboratory operations in order to verify that accurate, precise, and reliable data are being generated for clinical trials;
* Interact with corporate leadership, scientific liaison, project management, administration, government agencies, accrediting agencies, and potential sponsors/clients to gain information and knowledge required to make appropriate business and/or operational recommendations and decisions;
* Participate in general capabilities and bid defense meetings with sponsor;
* Ability to troubleshoot technical issues related to quantitative PCR and Sanger sequencing. Ability to understand Next Generation Sequencing (NGS) workflows and procedures; be able to communicate with Bioinformatics data analysis scientists on NGS quality issues.
* Ability to meet aggressive timelines (e.g., validation, database lock etc.);
* Routine molecular data analysis, review, and approval of clinical reports with aggressive timelines
* Develop and conduct training within molecular genomics;
* Maintaining instrument compliance with 21 CFR Part 11;
* Review and write Validation Plans/Reports/SOPs and;

Qualifications:

* PhD in Laboratory Medicine, Molecular Biology, Biochemistry/Biotechnology, Clinical Pathology or other similar area;
* 2-3 years of experience in molecular assay design, assay development in a clinical diagnostics environment or a translational research laboratory.
* Experience with analysis of qPCR data is required. Analysis of Sanger sequencing and NGS data is very desirable;
* Excellent record keeping skills are required;
* Analytical Method Validation experience is preferred;
* Previous experience in a central lab environment is preferred;
* Experience with human samples is preferred.
* Excellent interpersonal skills to effectively interact with and influence stakeholders, both internally and externally, are required.
			

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