Senior Manager, Physicochemical CMC Development, Biosimilars
Purpose of the role :
You will be accountable for development and implementation of the CMC analytical strategy for biosimilars from project initiation to phase 3 and market.
You will supply strategic and scientific expertise to guide Development Teams towards biochemical and biophysical analytical packages showing analytical similarity and comparability.
You will review and validate analytical sections of dossiers delivered to regulatory agencies.
Key tasks and Responsibilities :
Provide guidance across biosimilar projects on scientific and quality strategy applicable to analytics
Oversee CQA assessment and establishment of analytical similarity corridor (Quality Target Product Profile) using state of the art analytical assays
Interpret complex physicochemical data and assess their relevance at the functional level
Develop with scientists within Analytical Team and / or CROs stage-adapted analytical toolbox for manufacturing clone selection, process development, demonstration of analytical similarity at large scale and assessment of comparability.
Create and maintain detailed, ambitious yet realistic analytical testing plans ensuring rigorous and timely decision making that maintains rapid project progression
Manage direct / indirect interaction with Analytical Teams and external CROs / CMOs respectively, including setting expectations and monitoring progress
Prepare statistical analysis plans and similarity assessments with CMC Statistics
Work with project managers to review submissions including Briefing Book, IND, IMPD etc. prior to regulatory consultations
Understand project strategy and highlight risks and issues, propose mitigation
Represent SwissBioSim at regulatory authority meetings and at internal review committees
Ensure that biosimilar mindset and specific requirements are communicated and adhered to by the dedicated internal and external resources
Build and maintain scientific excellence in analytical research
Remain abreast of new developments in the Biosimilar field, and contribute to building business insight and knowledge within the Biosimilars team
Understand corporate quality standards and ensure they are adhered to in the area of Biosimilars
Main Interfaces :
Internally : Members of the Biosimilars Leadership and Development Teams, CMC Regulatory, CMC Statistics, Head of Pre-Clinical Pharmacology Biosimilars, Analytical Operational Team, Process Development and Manufacturing Science
Externally : Regulatory agencies; CROs, CMOs, licensing partners, scientific leaders in biochemical and biophysical analytical research.
Profile : Education & Languages
Education & Languages
Professional skills and Experience
o streamlining phase specific method development and validation (including method transfer) utilizing QbD and DoE principles
o Significant exposure to biotech manufacturing operations and related analytics with responsibility for establishing pharmacopeial compliant DS and DP analytical control strategies
Personal skills & competences