Senior CMC Analytical Life Cycle Manager
- Experience Level
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 CMC Analytical Life Cycle Manager to join them on a permanent basis in Nyon, Switzerland.
- Co-operate with CMC Development teams, Regulatory Affairs and Quality functions to co-ordinate and deliver analytical packages of the required standard for adherence to Global Health Authorities (in particular US and EU) requirements.
- Work with project managers to write and review analytical relevant sections of Health Authority submissions including BLA and MAA and post-approval variations.
- Manage direct/indirect interaction with internal Analytical Teams in support of Phase III development, Biosimilar licence application and post-marketing support ensuring scientific rigor and data integrity.
- To work with Quality function to review and implement QTAs. Initiate and process CCPs and deviations with analytical SMEs.
- Develop risk management strategies for product lifecycle maintenance.
- Interface with external CROs, CMOs and licensing partners to set expectations, define work packages, measure progress and delivery including continuous method performance monitoring.
- Development of long-term plans for analytical support of licensed Biosimilar products.
- Represent the organisation's SwissBioSim at regulatory authority meetings and at internal review committees.
- Provide guidance across biosimilar projects on scientific and quality strategy applicable to analytics.
- Ensure rigorous and timely decision making that maintains rapid project progression while continuously weighing the many variables and uncertainties associated with the biosimilar business.
- Understand the organisation's corporate quality standards and ensure they are adhered to in the area of Biosimilars.
- Strong analytical and organizational skills.
- Leadership competencies (proactive problem solving, influencing and decision making).
- Ability to work accurately with attention to detail, motivated and focused on delivery to product objectives.
- Robust communication skills, both oral and written.
- Strong interpersonal, networking and relationship skills required, including teamwork and listening skills.
- Advanced scientific degree: MSc or equivalent with degree in biochemistry, and post grad training in respective fields.
- At least 10 years' experience in R&D in biopharma/biotech industry.
- Demonstrated successful track record in analytical sciences of biologics, preferably biosimilars+
- Sound knowledge in GLP/GMP, ability to interpret guidelines and to implement compliant analytical packages in highly regulated markets
- Proven experience in regulatory consultations for biosimilar products (preferably) and/or New Biological Entities in the EU/US
- Significant exposure to biotech manufacturing operations and related analytics from Phase iii development to licensed Biopharmaceuticals including product life cycle management and product maintenance
- Demonstrated success operating in a global matrix organization with the full breadth of functions contributing to drug development and product supply chain
- Fluency in English essential, both oral and written; additional languages (German or French) are an asset.
If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" 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.