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Senior Automation Scientist

IQVIA Holdings Inc.

Durham, North Carolina

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:  Lead the investigation, creation and development of new strategies, method validations and technologies for high through-put laboratory automation process improvements. These contributions are integral to the success of the business as a dynamic, high-throughput genomic laboratory specializing in clinical trial testing. Projects will require experience of appropriate technical and/or scientific area(s) of molecular biology and implementation of laboratory instrumentation including automation platforms.  As an integral member of the laboratory automation team, this individual will work directly with colleagues in the automation team, Laboratory Operations, Assay Development, Information Technology, and other stakeholders to understand requirements, to create and elaborate novel automation solutions, or that improve existing automation solutions.

Duties and Responsibilities

  • Adhere to all Q Squared Solutions policies, procedures and employee handbook contents.
  • Introduce and drive implementation of new technologies to improve processes for departmental and business unit objectives.
  • Development and validation of molecular assays using custom or bespoke automated solutions.
  • Interface directly with team members and internal clients in Laboratory Operations, Assay Development and Information Technology to understand and refine requirements for process improvement and to coordinate activities accordingly.
  • Responsible for, with increasing accountability for, creation and review of experimental designs, method validation protocols, plans, procedures, product/process documents and reports to achieve department objectives.
  • Responsible for the development and validation of new processes
  • Critically review new technology on an ongoing basis to understand suitability towards Q Squared Solutions business strategy.
  • Function in a team environment, recognizing that priorities will shift according to business needs and maintain a flexible work schedule.
  • Drive the development of new experimental techniques, while maintaining/refining existing techniques, as well as the setup and execution of validation protocols including IQ/OQ/PQ documentation.
  • Communicate effectively across functions and manage relationships with internal and external partners and customers.
  • Identify new industry/technology trends shaping the area of expertise.
  • Support training and guidance of lower level and new staff as required.
  • Review and write SOPs and other documents as needed.
  • Perform other duties, as assigned

Knowledge, Skills, and Abilities

  • Working knowledge of GxP, CLIA and HIPAA requirements.
  • Knowledge and experience working with contemporary molecular biology techniques, including DNA/RNA manipulation, qPCR and sequencing.
  • Validation of molecular assays methods requiring isolation of nucleic acid and detection using amplification, nucleic acid sequencing, genotyping, or gene expression analysis.
  • Excellent planning and organizational skills, as well as maintaining close attention to detail is essential.
  • Capable of contributing to multiple projects simultaneously.
  • Superior oral and written communications skills.
  • Proficient user of standard office productivity software such as Microsoft Word, Excel and PowerPoint, along with basic statistical analysis.
  • Experience with Automated Liquid handlers is strongly preferred.

Credentials and Experience

  • BS/MS in Molecular Genetics or related field, or an equivalent combination of education, training and experience.
  • Minimum of 5 years of experience in molecular biology, with significant experience in a laboratory setting developing automation solutions.
  • Experience in a clinical laboratory operating under GxP and/or CLIA guidelines and direct experience with clinical trials is preferred.

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.

Job posted: 2020-12-24

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