Stefan Bibow

Associate Director, Drug Substance PD at CSL

Bern, Berne, Switzerland

About

Group leader, PMP-certified project manager and protein purification expert with extensive experience in biologics purification (recombinant and plasma) and protein structure determination. The teams under my leadership have successfully transferred several biologics purification processes from the lab into large-scale GMP facilities on time and in full. I am interested in performance management, strategy implementation and organisational resilience. My current book recommendation: "Where good ideas come from" by Steven Johnson. I love spending time with my family either above or under water :-) My guiding principle: first understand, then be understood.

Experience

  • Associate Director at CSL
    Feb 2024 - Present · 2 yrs 6 mos

    • Lead multiple cross-functional teams developing, optimizing, and scaling plasma-derived biotherapeutic processes from early research to commercial readiness • Evaluate and implement innovative technologies to improve process performance, robustness, scalability, and product quality across new and established plasma protein processes •Provide strategic and operational leadership to process development teams, including resource planning and prioritization across concurrent projects • Drive drug substance process development for major manufacturing changes, ensuring successful implementation and commercial readiness • Serve as a core member of cross-functional CMC delivery teams, contributing to governance and aligning development with program objectives • Prepare, review, and approve technical documentation and regulatory submissions in line with Quality by Design (QbD) principles • Champion a QbD culture and drive innovation, continuous improvement, and adoption of advanced manufacturing technologies • Partner with Process Engineering on scale-up, technology transfer, and facility fit for seamless transition to commercial manufacturing • Lead talent development—hiring, mentoring, and succession planning—to build a high-performing team aligned with strategic goals

  • Lonza (4 yrs)
    • Senior Project and Team Leader DSP Development
      Jun 2022 - Jan 2024 · 1 yr 8 mos

      • Leading the downstream process understanding and optimization activities of a late-stage biological drug to facilitate commercialization and tech transfer from lab scale (10-20 L) to large scale production (1'000 and 15'000 L) • Planing and analysis of custom DoEs and subsequent Monte Carlo Simulations to understand process parameter impact on CQAs using JMP • Introduced the Lonza Microbial Organization during the Lonza Welcome Days to new employees in Visp

    • Project and Team Leader DSP Development
      Feb 2021 - May 2022 · 1 yr 4 mos

      • Process development of a downstream purification process for a biosimilar, including refolding DoEs, data analysis with JMP, enzymatic reaction optimization and resin screening • Coordination and development of my project teams and my direct reports • Use of LIMS, JMP, Unicorn, PowerBI

    • Project Leader DSP Development
      Feb 2020 - Jan 2021 · 1 yr

      • Tech transfer of a mRNA purification process (purification of pDNA) to large scale • Downstream process development and optimization for a biological product to facilitate up-scaling to production scale (15'000 L) • Coordination of project teams in a matrix organization

  • SNSF Ambizione Fellow / Junior Group Leader at Biozentrum, University of Basel
    Jan 2017 - Dec 2019 · 3 yrs

    • Soluble and membrane protein expression (Sf9, e.coli), refolding and purification • Atomic-resolution investigation of lipid-induced membrane protein dynamics in lipid-bilayer nanodiscs • co-organizer of a retreat for postdocs from industry and academia

  • Postdoctoral Researcher (ETH fellowship) at ETH Zürich
    Jan 2012 - Dec 2016 · 5 yrs

    • gene design, expression, refolding and purification of soluble and membrane proteins • Structure determination of discoidal HDL particles by combining NMR, EPR and cryo-EM • Structural and dynamics characterization of OmpX in micelles, bicelles and nanodiscs • Supervising PhD students

  • Visiting Scientist at Salk Institute for Biological Studies
    Sep 2012 - Dec 2012 · 4 mos

    Expression and purification of Somatostatin receptor 5