Senior Manager (Physicochemical CMC Development/Biosimilars)
- Permanent
- Technical Operations
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Hobson Prior are working with a world-wide healthcare organisation whose products and services are used to help care for patients who are critically ill. Our client is looking for a Senior Manager (Physicochemical CMC Development or Biosimilars) to join them on a permanent basis in Eysins, Switzerland. You will be accountable for development and implementation of the CMC analytical strategy for biosimilars from project initiation to phase 3 and market.
Job Responsibilities:
- You will deliver guidance across biosimilar projects on scientific and quality strategy applicable to analytics.
- Understand complex physicochemical data and assess their relevance at the functional level.
- Develop with scientists within the 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.
- Oversee CQA assessment and establishment of analytical similarity corridor (Quality Target Product Profile) using state of the art analytical assays.
- 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 the organisations 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 the organisation 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.
Key Skills:
- Excellent analytical and strategic skills.
- Leadership competencies.
- 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.
Requirements:
- Advanced scientific degree: PhD or equivalent with degree in biochemistry, bioanalytics and post grad training in respective fields.
- A minimum of 10 years' experience in R&D in biopharma/biotech industry.
- 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.
- Fluency in English essential, both oral and written; additional languages (German or French) are an asset.
Apply now:
If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.
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