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Immunoassay Method Development (Associate Principal Scientist)

Aplica ya
Mapa de ubicación: Durham, North Carolina, United States Full time R1227356

Descripción del trabajo

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. 

RESPONSIBILITIES

  • Execution of ELISAs, cell-based assays and other immunoassay techniques as required in a BSL2 lab under direction of project leader.
  • Learn and perform required laboratory techniques using novel and established protocols and Standard Operation Procedures under the direction of project leader.
  • Perform assays under direction of the project leader.
  • May act as project leader depending on experience/training level.
  • Sample accessioning/handling according to SOP using LIMS system, as required.
  • Perform data analysis, upload run data/results to LIMS system with assistance of project leader.
  • Preparation of stock buffers.
  • Prepare stock and working solutions/standards and QC samples as directed.
  • Aliquot standards, controls, control matrices and other reagents as required.
  • Accurately dispense proprietary/commercial compounds for the preparation of reference material and assay reagents according to direction of project leader or designee.
  • Responsible for documentation of all project work in appropriate laboratory notebooks according to Q² Solutions and GLP procedures and processes.
  • Prepare and review run binders and notebooks and other project-related documentation with assistance.
  • Assist in changes in Standard Operating Procedure for modifications of existing processes.
  • Ability to work a flexible schedule and adapt efficiently to program changes.
  • Production of quality data and documentation in adherence to timelines and maintenance of GLP functions in the lab.
  • Responsible for ordering and stocking of laboratory supplies as directed.
  • Maintenance of MSDS and chemical inventory as needed.
  • Maintenance of Calibration certifications and CoA files.
  • Maintenance of laboratory instrumentation as directed.
  • Monitor laboratory systems as directed.
  • Routine safety inspections as directed.
  • Maintain personal training file and assist in training of other technical staff if needed.

MINIMUM REQUIRED EDUCATION AND EXPERIENCE

  • Bachelor’s Degree in Chemistry or a related field with 1 year of related experience; or equivalent combination of education, training and experience in GLP laboratory environment.

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

  • Technical knowledge of serological immunoassay techniques, instrumentation, sample handling and preparation, and data analysis.
  • Technical knowledge in key areas of cell-culture and cell-based immunoassays.
  • Ability to maintain clear and efficient method development documentation
  • Ability to optimally maintain long-term culture as needed
  • Ability to assist with the development of cell-based assays
  • Ability to perform accurate and precise processing of client samples
  • Ability to follow scientific directions and work in a team
  • Ability to complete documentation per GLP (Good Laboratory Practices) requirements
  • Ability to adhere to SOPs (Standard Operating Procedures)
  • Ability to follow verbally communicated or draft procedures
  • Experienced in all routine laboratory procedures
  • Understanding of development/validation of methodology
  • Ability to work to objectives/timelines
  • Excellent attention to detail and communication skills
  • Ability to establish and maintain effective working relationships with coworkers, managers and clients

PHYSICAL REQUIREMENTS

  • Extensive use of keyboard requiring repetitive motion of fingers
  • Ability to lift-up to 40lbs
  • Regular standing and sitting for extended periods of time

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law.

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.

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