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; Prepare and update Annual Process Development History Reports
Prepare, author and review the relevant CMC sections of regulatory dossiers
Serve as the technical upstream subject matter expert for regulatory consultations/interactions, including briefing book and dossier preparation and question-response phase with authorities
Represent Upstream Team at cross functional internal and external meetings
Minimum Masters or Bachelors degree in life sciences or engineering
Fluency in English; French would be an asset
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
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 20-30% of the time based on business needs principally to manufacturing sites and to I&D center located in Switzerland
Ability to work in a matrix organization
Note: No direct reports for this position