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Job Detail

Senior Scientist - Global Technical Operations - Analytical

Experience Level

5-7 Year(s)


Gaithersburg, MD (remote)

Posted Date

Job Requirements

Position Description:
This position will provide overall scientific and strategic leadership for  bio analytical operations network leading strategic analytical projects and supporting Science and Technology Excellence.

Essential Job Functions:
Key area of responsibility will be enterprise wide analytical activities in Operations, which include the following functions.

  • Responsible for analytical method transfer 
  • Biopharmaceutical Development or Global Technical organization to commercial manufacturing sites as well as outside testing laboratories
  • Responsible for developing pragmatic implementation plan, by working with stakeholders from cross functional areas
  • Responsible for ensuring harmonized compliance to internal standards and policies related to analytical operations supporting third party suppliers
  • Foster creative collborations between R&D, Operations and the third-party suppliers to progress the projects and coming up with win/win solutions
  • Author/Review technical documents in the subject matter for regulatory submissions as needed
  • Provide input and review for regulatory filings to ensure consistency in depth of content and strategic approach
  • Provide forward thinking in anticipation of future needs

Position Qualifications:
Knowledge and Scope

  • Experience in cell culture, Immuno assay, PCR, next generation genome sequencing, biologics, residuals and impurities assay, analytical method development, transfer and method validation- Vaccine experience preferred. Leadership experience in leading global team and working with CMO is essential
  • Must have significant experience with most of the following standard analytical techniques used in the biopharmaceutical industry: e.g., UV-Vis, HPLC, LC-MS, GC, FT-IR, SDS-PAGE, IEF, CE, ELISA, mass spectrometry, bioassay.
  • Has a working knowledge of biosafety testing and microbiology requirements in a manufacturing environment
  • Analytical method development and validation experience; knowledge of cGMP practices and ICH requirements
  • Leadership experience in leading global team and working with CMO is essential

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