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Senior Manager (m/f/d) Upstream Process Development
Eysins (Schweiz)
Aktualität: 11.03.2023


11.03.2023, Fresenius Kabi
Eysins (Schweiz)
Senior Manager (m/f/d) Upstream Process Development
Main Tasks: Oversee and guide outsourced (CDMO) upstream activities around the technical development of a Biosimilar; 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 Provide scientific and technical coaching and guidance for the upstream process development activities for in-house development labs 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 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; 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 Review and approve external technical development protocols / reports; Prepare and update Annual Process Development History Reports Prepare, author and review the relevant CMC sections of regulatory dossiers Serve as the technical upstream expert for regulatory consultations / interactions, including briefing book and dossier preparation and question response Represent Upstream Team at cross-functional internal and external meetings
Sionals, enabling them to find the right answer to the challenge they face. Fresenius Kabi is a driver of healthcare for the coming decade. We truly live diversity and value different backgrounds and motivations. Around the world, all of us are committed to our shared endeavor: caring for life. Education and languages: Minimum Master or Bachelor degree in life sciences or engineering Fluency in English; French would be an asset Professional skills and experience: Minimum 7 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, furthermore, experience with microbial expression systems (e.g. E. coli ) is an advantage; 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, and process validation Specific skills and competencies: Technical leadership and influencing skills to drive teams to deliver Collaborative, drives engagement and ensures accountability Strong analytical skills and ability to critically evaluate scientific data obtained at different stages of development Ability to work on multiple projects concurrently and flexibility to switch between projects if necessary Strategic thinking and cultivates innovation Willingness to travel up to 20 % of the time based on business needs Ability to work in a matrix organization Note: No direct reports for this position



Senior Manager (m­­/­­f­­/­­d) Upstream Process Development

Eysins (Schweiz)