Senior Manager CMC Data Analytics

Do you have a solid experience in statistics and a CMC experience in a Biotechnology industrial setting? Are you recognized for your excellent analytical and organizational skills? Are you looking for your next challenging role?

In this case, you should have a look at this opportunity!

Our client, an international biotechnology industry based in the Geneva area is looking for a:

Senior Manager CMC Data Analytics
(permanent contract)

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 withlaboratories, 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 / biosimilars
• 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 forproductsin 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 fullbreadth of functions contributing to drug development and product supply chain