Dr. Simon S. Gerber

Bioprocess & CMC Leadership (Plasma & Recombinant) | +10% IgPro yield

Bern, Berne, Switzerland

About

I design and scale robust downstream processes that make plasmaderived proteins and recombinant proteins (fusion proteins & mAbs) reproducible, compliant, and commercialready. With 15+ years in Bioprocess Development (CMC), I lead crossfunctional global teams and turn complex technical programs into measurable outcomes. Signature results include a +10% yield improvement in CSL’s IgPro process (Privigen®/Hizentra®) and the implementation of an isoagglutininremoval step to strengthen product safety. I also led Phase III/commercial process development for Garadacimab (mAb) and built predictive scaledown models used across multiple assets and sites. My core strengths span Downstream processing, Scaledown & scaleup, Tech transfer (internal & external), site comparability, deviation investigations, process characterization, facility fit, and regulatory authoring (IND/BLA). I’m comfortable partnering with QA/Manufacturing, Research, and external CMOs to drive lifecycle improvements and resolve critical deviations under tight timelines. Current focus: advancing an ethanolfree, lowOPEX, highyield downstream process for human Albumin, integrating rigorous comparability and validation principles to ensure developability and commercial readiness. If you’re working on CMC strategy, yield optimization, scaledown model fidelity, tech transfers, or regulatory readiness, let’s connect—I enjoy swapping lessons learned and collaborating on approaches that make biologics safer, more robust, and simpler to manufacture.

Experience

  • CSL (9 yrs 11 mos)
    • Director Early Research Supply, Global Process Development at CSL Behring
      Mar 2025 - Present · 1 yr 4 mos

    • Director, Bioprocess Development, Global Plasma Product Development at CSL Behring
      Sep 2022 - Present · 3 yrs 10 mos

    • Associate Director, Bioprocess Development, Global Plasma Product Development at CSL Behring
      Jun 2019 - Sep 2022 · 3 yrs 4 mos

  • CSL Behring (6 yrs 3 mos)
    • Manager deputy
      Mar 2015 - Jun 2016 · 1 yr 4 mos

      u.a. Personalführung, Projektverantwortung, Prozessentwicklung, Evaluierung und Etablierung neuer Technologien sowie Vertretung der Abteilung in globalen Projektteams

    • Teamleader
      Nov 2013 - Feb 2015 · 1 yr 4 mos

    • Scientist
      Apr 2010 - Oct 2013 · 3 yrs 7 mos