Fresenius Kabi Austria is a subsidiary of Fresenius Kabi AG, a world-leading manufacturer of infusion therapy and clinical nutrition products. With headquarters in Graz and a production site in Linz, the company has 1600 employees and ranks among the top enterprises in the region.
About Us
We value our employees and offer:
* A reliable employer
* Strong global growth opportunities
* International career possibilities
* Comprehensive training and further education
* Active health promotion
* Free parking
* Canteen
* Joint corporate events
Contact Person:
Fresenius Kabi Austria GmbH
Mag. Celina Gößler, MA
Hafnerstraße 36
8065 Graz
Karriere-Fresenius-Kabi
Job Description:
Sr Manager Upstream Process Development (m/f/d)
Responsibilities:
We are seeking a Senior Manager to oversee and guide outsourced upstream process and cell bank related activities around the technical development, approval, and life cycle management of Biosimilar drug substance production. Key responsibilities include:
* Overseeing and guiding outsourced upstream process and cell bank related activities for Biosimilar drug substance production
* Providing scientific and technical oversight for upstream process development activities at drug substance manufacturing CDMOs
* Defining technical development that follows Quality by Design principles in line with relevant regulatory requirements and guidelines
* Leading technology transfer activities for handover and scale-up of projects to external GMP manufacturing sites or commercial products
* Driving and supporting upstream troubleshooting and root-cause investigation activities at the CDMO during Technology Transfer, GMP Manufacturing, PPQ, and commercial campaigns of approved products
* Reviewing and approving external technical development protocols/reports and preparing Annual Process Development History Reports
* Serving as a technical upstream subject matter expert for regulatory consultations/interactions, including briefing book and dossier preparation and question-response phase with authorities
Requirements:
We expect you to have:
* Bachelor's or Master's degree in life sciences or engineering
* Minimum 10 years of 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 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, primarily to manufacturing sites and I&D center located in Switzerland
What We Offer:
We provide international challenges in a dynamic corporate environment, corporate social events, and an attractive performance-related salary package (annual gross salary starting at EUR 75,000,-).