Senior Manager Downstream Process Development and Manufacturing Sciences (m/f/d), Eysins

Fresenius Kabi ist ein weltweit tätiges Gesundheitsunternehmen, das Medikamente und Medizinprodukte zur Infusion, Transfusion und klinischen Ernährung anbietet. Unsere Produkte und Dienstleistungen werden in der Therapie und Versorgung von kritisch und chronisch kranken Patienten eingesetzt.

Main Tasks

• Oversee and guide outsourced (CDMO) downstream 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 downstream 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 DSP 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 downstream troubleshooting and root-cause investigation activities at the CDMO during Technology Transfer, GMP, 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 downstream expert for regulatory consultations/interactions, including briefing book and dossier preparation and question response
• Represent Downstream at cross functional internal and external meetings

Your profile

Education and languages:

• Minimum Masters or Bachelors degree in life sciences or engineering
• Fluency in English; French would be an asset

Professional skills and experience:

• Minimum 7 years experience in the Biotech Industry with demonstrated track record in Downstream processing for biologics (preferably a mammalian cell culture downstream and monoclonal antibody experience); previous experience working with biosimilars would be an advantage
• Strong technical expertise across the Downstream development spectrum including process development, scale up and tech transfer, large scale manufacturing, process characterization, and process validation

Job 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