Remote: Sr Scientist- Analytical Life Cycle (227119)

Life Sciences & Technology | Validation

Location: Remote   

Required Skills:

  • Proficient in Spotfire, SQL, Python, R as well as ability to develop sophisticated visualizations
  • Experience in developing simple software solutions to complex large data sets
  • Experience in working with large sets of structured and unstructured data
  • Knowledge of MS Excel programming

Essential Job Functions:

  • Responsible for analytical method lifecycle management strategy and execution
  • Provides overall leadership to analytical method performance monitoring across sites
  • Develop predictive models and determine the appropriate approaches or techniques to evaluate analytical method issues and potential solutions
  • Lead analytical method reviews to drive compliance
  • Serve as a the business process lead for analytical method life cycle management.
  • Work cross functionally to continuously improve the analytical method capability for biologics
  • Actively contribute to the preparation of internal audits and regulatory inspections (on-site)
  • 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
  • Ensure compliance to internal procedures, Quality Systems, applicable GMP regulations globally, and understand and maintain industry standards.
  • Responsible for establishing and simplifying process of data analytics employing novel data mining tools.
  • 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

Position Qualifications:

  • Proficient in Spotfire, SQL, Python, R as well as ability to develop sophisticated visualizations
  • Experience in developing simple software solutions to complex large data sets
  • Experience in working with large sets of structured and unstructured data
  • Understanding of cell culture, Immuno assay, PCR, next generation genome sequencing, biologics, residuals and impurities assay, analytical method development, transfer and method validation
  • Analytical method development and validation experience; knowledge of cGMP practices and ICH requirements
  • Demonstrates the ability to effectively explain complex scientific concepts to a broader, diverse audience.
  • Proficient in project management and stakeholder management skills
  • Experience in using Lean/continuous improvement methodology for process improvement
  • At least bachelors degree in mathematics or biological or engineering required with 5-10 years relevant experience

 

JOB ID# 227119

#LI-NG1

Start Date
ASAP
Location
Remote

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