Job Detail

permanent employment

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 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 / 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 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

 if you recognize yourself in this ad, don't wait any longer and apply now!



This ad was posted by Angèle, your Senior Recruiter from Randstad Geneva.

Do you want to know more about her? Take a look at her video introduction by clicking here.