Senior Manager
Hobson Prior
Switzerland, Switzerland
vor 15 Tg.

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

  • Advanced scientific degree : PhD or equivalent with degree in biochemistry, bioanalytics and post grad training in respective fields
  • Fluency in English essential, both oral and written; additional languages (German or French) are an asset
  • Professional skills and Experience

  • Minimum of 10 years’ experience in R&D in biopharma / biotech industry
  • Specific experience of either of the following will be considered an advantage : -
  • 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

  • Demonstrated successful track record in analytical sciences of biologics, preferably in the field of biosimilars
  • Proven experience in regulatory consultations for biosimilar products and / or New Biological Entities in the EU / US
  • Demonstrated success operating in a global matrix organization with the full breadth of functions contributing to drug development
  • Personal skills & competences

  • Excellent analytical and strategic skills
  • Leadership competencies (proactive problem solving, influencing and decision making skills)
  • Ability to work accurately with attention to detail, motivated and focused on delivery to product objectives to challenging timelines
  • Excellent communication skills, both oral and written
  • Strong interpersonal, networking and relationship skills required, including team work and listening skills
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