Senior Manager CMC Data Analytics
Randstad Professionals Switzerland
Lausanne
vor 1 Tg.

MAIN TASKS :

  • Develop and implement an approach to CMC data management and integrate CMC data analysis across the RDMS organization
  • Strengthen and build cross-organizational partnerships with laboratories, QA and IT groups to enable compliant CMC data management, integration, and analysis
  • Strengthen core CMC statistical capability consisting of data management, programming, and reporting
  • Support statistical approach to CMC data (e.g. similarity assessments establishment of specifications, bridging of analytical methods, bridging of reference standards, method performance monitoring DoE-assisted developments, etc), both internally in process development and analytical development labs and externally at CRO / CMOs
  • Ensure applicability and compliance of statistical tools used for data analysis to enable CMC development and submission of biosimilar applications in highly regulated markets
  • Drive implementation, maintenance and upgrade of integrated CMC data analysis platforms to enable phase appropriate analyses
  • Analyze internal operations and identify areas of improvement
  • PROFILE :

  • Advanced scientific degree : PhD with degree in statistics or Master with post grad training in respective fields
  • Fluency in English is required
  • WORK EXPERIENCE :

  • Minimum of 10 years+ experience in the biopharmaceutical industry
  • Demonstrated successful track record in CMC statistical sciences of biologics.
  • Command of statistical data analysis softwares e.g. SAS, JMP, etc
  • Sound knowledge in GLP / GMP, ability to interpret guidelines and to implement compliant data analysis packages in highly regulated markets
  • Proven experience in regulatory consultations for products in the EU / US
  • Thorough understanding of some aspect of CMC operations; interest and demonstrated ability to learn across several disciplines (technical development manufacturing, analytics, tech transfer, quality, regulatory, etc)
  • Demonstrated success operating in a global matrix organization with the full breadth of functions contributing to drug development and product supply chain
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