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Senior Scientist
Morristown, NJ
$40-44/HR

Senior Scientist will perform extensive laboratory work to support pre-formulation, formulation development, technology transfer activities, clinical trials, and evaluation of product performance and stability.

Senior Scientist Responsibilities:
  • Performs extensive laboratory work to support pre-formulation, formulation development, technology transfer activities, clinical trials, and evaluation of product performance and stability.
  • Conducts analytical method development, method validation and transfer
  • Performs analytical laboratory work to support product development
  • Accurately and timely documents the experiments and results into the notebooks, ELN and LIMS (if required)
  • With minimum supervision, manages projects to ensure all tests are completed on time, results are accurate, and all activities are documented.
  • Effectively communicates to all stakeholders the analytical activities and findings.
  • Follows SOPs/OIs and analytical laboratory practices to ensure the work quality and compliance
  • Writes the analytical methods, specifications, method validation reports, experimental reports, and SOPs/OIs
  • Performs GMP comprehensive review of analytical activities such as but not limited to method development, method validation, method transfer, testing of analytical product development batches, process optimization batches, stability submission batches and instrument technical records
  • Interacts with analysts on the data review to recommend appropriate corrections / modifications / improvements needed to build consistency with respect to documentation practice guideline

Senior Scientist Requirements:
  • Bachelor’s degree in Science, or international equivalent, with a 7+ years of proven Pharmaceutical Analytical Laboratory experience OR A Master’s degree or higher in Science, or international equivalent, with a 5+ years of proven Pharmaceutical Analytical Laboratory experience
  • Must have QC or R&D experience in pharmaceutical industry
  • Specific Hands-on experience with Waters & Agilent HPLC / UPLC and dissolution apparatus (USP Type 1 and 2)
  • Understands fundamental analytical chemistry and chromatography.
  • Able to troubleshoot testing and/or analytical method related issues.
  • Expertise in Waters Empower3 CDS
  • Practical knowledge and experience with application of analytical method development and method validation activities
#INDHP

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