Staff Scientist, Assay Development

Q2 Solutions is a leading clinical trial laboratory services organization with end-to-end laboratory services and secure, enterprise-wide biospecimen and consent management solutions. With a relentless focus on quality and innovation, Q2 Solutions uses its global experience and scientific expertise to transform science and data into actionable medical insights that help customers improve human health.  A joint venture of IQVIA (formerly QuintilesIMS) and Quest Diagnostics, Q2 Solutions combines the best of each parent organization’s clinical trials laboratory services capabilities to fulfill its mission of treating each sample as if a life depends on it.

Job Summary: The Staff Scientist will be responsible for the development and validation of nucleic acid-based molecular assays to support clinical trials. The Staff Scientist will determine the analytical requirements of an assay through direct communications with external and internal clients, will develop an experimental approach, establish feasibility through designed experiments, create a validation plan commensurate with the intended use of the assay, conduct the validation, create the report, and support additional activities required for assay implementation in a high-throughput genomics laboratory. Goals will be met via individual contributions and supervision of supporting laboratory staff. The Staff Scientist is also responsible for developing budgets and tracking ongoing costs, establishing and adhering to time-bound project plans, maintaining regulatory compliance, and communicating progress to internal and external stakeholders.

Duties and Responsibilities

•             Adhere to all Q Squared Solutions policies, procedures and employee handbook contents.

•             Serve as an Assay Development lead on new assay/method development and process improvement initiatives involving contemporary genomic technologies.

•             Evaluate new genomic technologies, develop, optimize and validate methods, and drive their implementation within the assay development team and in the production lab.

•             Serve as a Subject Matter Expert (SME) in molecular biology, oncology, immunology, microbiology, and/or human genetics in internal and external interactions. 

•             Engage, communicate, and influence clients on assay development strategies.

•             Coach/mentor professionals in a broad scope of technical, product and professional subjects.

•             Seeks, identifies and delivers on opportunities to publish (posters, patents, journals) as applicable to our business focus.

•             Responsible for creation and review of experimental designs, protocols, plans, procedures, product/process documents and reports to achieve department objectives.

•             Leads/facilitates technical and strategic discussions and decision making across functions.

•             Uses sound judgment and thinks through impacts of situations, options, and broader impact as well.

•             Liaises with other functions such as Project Services, Bioinformatics, Software, Operations, and Quality to achieve business unit objectives

Knowledge, Skills and Abilities

•             Working knowledge of GxP, CAP/CLIA and HIPAA requirements, including preparing compliance documentation.

•             Deep knowledge and demonstrated expertise in the use of contemporary molecular biology and genomic methods.

•             Superior oral and written communication skills; demonstrated ability to summarize, analyze and convey complex information clearly and adjust communication to the audience.

•             In-depth understanding of risk management concepts and can assess product, process, project and schedule risks.

•             Leads by example in driving collaboration, encouraging team work, and motivating and recognizing the team. Removes obstacles to team work and collaboration.

•             Proficient user of standard office productivity software such as Microsoft Word, Excel and PowerPoint, along with basic statistical analysis.

Credentials and Experience

•             PhD or equivalent combination of education and experience equivalent in genomics, molecular biology, cancer biology or related field, with at least 8 years relevant experience in a professional setting.

IQVIA is an EEO Employer - Minorities/Females/Protected Veterans/Disabled

IQVIA, Inc. provides reasonable accommodations for applicants with disabilities.  Applicants who require reasonable accommodation to submit an application for employment or otherwise participate in the application process should contact IQVIA’s Talent Acquisition team at workday_recruiting@iqvia.com to arrange for such an accommodation.