Job Details

  • Title: Document Validation Scientist
  • Code: RCI-7400
  • Location:
  • Posted Date: 06/25/2020
  • Duration: 9 Months
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  Job Description

Must be able to work fully remote & in PST or EST

The Scientist role in Commercial Process Development will be responsible for the compilation and drafting of method validation protocols and reports for raw material methods. The position will be a documentation centric role and the candidate will need to have experience with document management systems.

  • Will be part of a team responsible for authoring method transfer and method validation protocols and reports for late stage and commercial programs
  • Technologies can include chromatography, spectroscopy, and compendia based methods
  • Will be supporting fixed program deliverables by ensuring protocols and reports are completed for developed and validated methods
Basic Qualifications:
  • PhD - 1+ years within a Pharma or Biotech environment OR Master’s degree and 3 years of Operations or Scientific experience within a Pharma or Biotech environment OR Bachelor’s degree and 5 years of Operations or Scientific experience within a Pharma or Biotech environment
  • **(Manager is looking for industry - non academia experience)**
  • Strong experience with method validation protocol and report writing from a Pharmaceutical or Biotechnology area
  • Experience in method validation document writing for pharma regulations
  • Experience with working remotely and delivering
  • Experience within biopharma company with analytical methods
  • Experience in method validation protocols and reports meeting ICH criteria
  • Strong project scientific management experience
  • Strong technical writing skills
  • A scientific background in Quality and/or Analytical Sciences will be appropriate