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Validation Scientist (Anatomic Pathology)

IQVIA Holdings Inc.

Valencia, California

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.

Responsibilities:

Management of validation requirements for all new immunohistochemical (IHC) and Fluorescent In-Situ Hybridisation (FISH) assays within the Anatomic Pathology Laboratory:

  • Serve as subject matter expert (SME) in initial contacts with sponsor to discuss feasibility/capability of validation proposals. Assures that proposal meets scientific objectives and are aligned with sponsor requirements.
  • Liaise with sponsors to maintain regular updates on validation progress.
  • Develop and optimize IHC assays on automated staining platforms (Dako Autostainer Link 48 and Ventana Benchmark ULTRA) and any other required equipment.
  • Develop and optimize FISH assays.
  • Co-ordinate tech transfer of validated assays as appropriate to other Q2 Solutions Laboratories by providing reagents, protocols and knowledge transfer.
  • Prepare validation plans to document the proposed scope of work and writes the final validation report detailing all the work completed with the accompanying data.
  • Responsible for sourcing and procuring reagents and samples from approved vendors.
  • Perform scientific literature reviews as appropriate for background preparation for validations.
  • Update validation status tracker with regular meetings with science team, global AP and QA.
  • Act as Anatomic Pathology SME and mentor fellow colleagues within AP.
  • Keeps abreast of latest industry developments in immune oncology and look to find business opportunities for introduction eg Multiplex IHC, (fluorescent and chromogenic) and image analysis based digital pathology.
  • Collaborates and liaises with other functional groups to accomplish specific objectives within project timelines.

Required Skills/Experience

  • Detailed and extensive experience of automated IHC using Dako Autostainer Link 48 and Ventana BenchMark ULTRA systems in a GCPL setting. Knowledge of staining methods (manual and automated for chromogenic and immunofluorescence assays including multiplex IHC is recommended.
  • Excellent attention to detail in writing, verbal, and presentation skills with proven experience in report and plan writing.
  • Experience with project management with evolving priorities and timelines.
  • Experience in a pathology services laboratory or academic core laboratory.
  • Excellent team and interpersonal skills.
  • Excellent time management.
  • Able to work on multiple validations concurrently.

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: 2020-06-03

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