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Contractor Head of Downstream Process Development (m/w/d) in Biotech Startup
Zürich, Schweiz |
Temporary Employment
Job title: Contractor Head of Downstream Process Development (m/w/d) in Biotech Startup
Industry: BiotechSkills: Biopharma, Downstream, Development
Start of project: 01.09.2023
Duration of the project : 18 months
Location: Zürich
Tasks:
- Strategically define the technical corridor for analytical similarity to be achieved when developing biosimilar products
- Oversee and guide in sourced (DSP laboratory) and outsourced (CDO, CMO) downstream activities around the technical development of a Biosimilar; including, downstream process development and generation of drug substance, technology transfer, clinical trial manufacturing, process characterization and validation, submission of CMC documents and Life Cycle Management activities for licensed products
- Define technical development that follows the principles of Quality by Design (QbD) and specify activities, timelines, milestones and costs in collaboration with other functions (e.g. Supply)
- Drive issue resolution in order to achieve Biosimilarity within the pre-defined analytical similarity corridor
- Review results and interpretation of the package developed to demonstrate in vitro analytical similarity and achievement of the biosimilar corridor and make recommendation on the way forward with the Biosimilar Product Teams
- Provide scientific and technical operational guidance for the downstream process development activities to the Biosimilars Product Teams and the Biosimilar Leadership Teams
- Provide technical and scientific oversight of licensed product
Qualifications:
- Phd or BSc in relevant scientific / technical discipline and extensive experience with demonstrated track record in biopharm/biotech companies, or equivalent organisations
>10 years in either academic/pharmaceutical/biotech company. Highly experienced in the area of biosimilars would be a strong advantage
- Strong leadership and motivational skills
Able to deal with uncertainty and work outside scientific comfort zone
- Proven ability to lead major and complex programs in area of scientific expertise
- Ability to critically evaluate scientific data obtained at different stages of development
- Entrepreneurial spirit and action/results driven
Referenznummer:
Branche:
Beginn des Projekts:
Dauer:
Anstellungsart:
Kontakt
Lars Uhl
13387
Biotech
Ab sofort
18 months
Temporary Employment
