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Associate Principal Scientist (Immunoassay Method Development)

Aplica ya
Mapa de ubicación: Durham, North Carolina, United States Full time R1312789

Descripción del trabajo

As an Associate Principal Scientist, candidate will be responsible for developing bioanalytical immunoassay or cell-based assays supporting PK/PD concentration and immunogenicity assessment. By applying expertise in ligand binding assays such as ELISA and ECLA, bioassay and immunological techniques to quantitate biotherapeutics and biomarkers and to characterize immune responses to biologics, candidate will turn hope into help by accelerating our partners’ drug development programs. Contributions to this platform of testing will support multiple modalities across the spectrum of drug development in a custom-built state-of-the-art laboratory that includes bioanalytical, vaccines, genomics, anatomical pathology, and flow cytometry laboratories.

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 7+ years 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.

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. https://www.q2labsolutions.com/careers

We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities. https://jobs.iqvia.com/q2-solutions-eoe

As the COVID-19 virus continues to evolve, Q² Solutions' ability to operate and provide certain services to customers and partners necessitates Q² Solutions and its employees meet specific requirements regarding vaccination status. https://jobs.iqvia.com/q2-solutions-covid-19-vaccine-status

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