Your tasks
* Oversee and guide outsourced (CDMO) upstream process and cell bank related activities around the technical development, approval and life cycle management of Biosimilar drug substance production, including process tech transfer, GMP manufacturing of drug substance, IND application authoring / review of CMC sections, process characterization and validation, and authoring / review of CMC sections for BLA/MAA, deviation and change control support as subject matter expert
* Provide scientific and technical oversight for the upstream process development activities at drug substance manufacturing CDMOs
* Define technical development that follow the principles of Quality by Design in line with relevant regulatory requirements and guidelines; specify activities required for preparation of Statement of Work (SOW); review the activities, timelines, and costs at drug substance manufacturing CDMOs
* Assume a leading role in the planning and execution of USP technology transfer activities for handover and scale up of projects to external GMP manufacturing sites or for tech transfer of commercial products; design and guide process characterization studies and process validation support activities
* Drive and support upstream troubleshooting and root-cause investigation activities at the CDMO during Technology Transfer, GMP Manufacturing, PPQ and commercial campaigns of approved products
* Review and approve external technical development protocols / reports and prepare and update Annual Process Development History Reports
* Serve as the technical upstream subject matter expert for regulatory consultations/interactions, including briefing book and dossier preparation and question-response phase with authorities
Our expectations
* Bachelors or Masters degree in life sciences or engineering
* Minimum 10 years relevant experience in the Biotech Industry with demonstrated track record in Upstream processing for biologics, preferably with mammalian cell culture and monoclonal antibody experience; previous experience working with biosimilars would be also an advantage
* Strong technical expertise across the Upstream development spectrum including process development, scale up and tech transfer, large scale manufacturing, process characterization, process validation and life cycle management of commercial products
* Fluency in English; French would be an asset
* Technical leadership and influencing skills to drive teams to deliver
* Strong analytical skills and ability to critically evaluate scientific data obtained at different stages of development
* Willingness to travel up to 20-30% of the time based on business needs principally to manufacturing sites and to I&D center located in Switzerland
We offer
* International challenges in a dynamic corporate environment
* Corporate social events
* Attractive performance-related salary package (annual gross salary starting at € 75.000,-, overpayment depending on occupational skills and experience)
We are caring for our employees
* Reliable employer
* Strong global growth
* International career opportunities
* Comprehensive education and training
* Homeoffice
* Jobticket
* Active health promotion
* Free parking space
* Bikeleasing
* Canteen
* Joint company events
Fresenius Kabi Austria
Frau Mag. Celina Gößler, MA
Hafnerstraße 36
8055 Graz
https://karriere-fresenius-kabi.at/ #J-18808-Ljbffr