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Smart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders

David Brühlmann - CMC Development Leader, Bioprocess Expert, Business Strategist

The go-to CMC and biomanufacturing podcast for bioprocess development scientists and CMC leaders scaling biologics into regulatory-ready therapies with less trial and error.


Practical, execution-focused, and strategic guidance on CMC development, tech transfer, scale-up, GMP readiness, CDMO partnerships, and manufacturing economics for biologics, cell and gene therapies, cultivated meat, and biomaterials.


Hosted by Dr. David Brühlmann, CMC strategist, former Bioprocess Innovation Manager at Merck, PhD in glycoengineering, and close to 20 years of biomanufacturing experience. Smart Biotech Scientist delivers actionable insights for the people doing the hard work of turning promising molecules into scalable, regulatory-ready therapies.


This podcast is for you if:


  • You are a process development scientist or CMC lead managing a technology transfer, scale-up, or CDMO partnership


  • You are a biologics developer working on upstream or downstream process development, cell culture optimization, or GMP manufacturing readiness


  • You are a biotech founder preparing for an IND filing or Series A fundraise, and need a CMC strategy that holds up under investor and regulatory scrutiny


  • You are building or advising an early-stage biopharma team and need to make smart manufacturing decisions with limited resources


What you will learn:


CMC strategy and regulatory planning, bioprocess scale-up from lab to clinical and commercial manufacturing, cell culture process development and media optimization, technology transfer best practices, CDMO selection and partnership management, hybrid modeling, manufacturing economics, continuous manufacturing, digitization, and Industry 4.0 in biopharma.


Top 10 life sciences podcast with 200+ episodes and guests from Merck, FUJIFILM Irvine Scientific, Cytiva, KBI Biopharma, Eppendorf, and biotech innovators worldwide.


New episodes released weekly. Subscribe and join 400+ biotech leaders already using these insights to accelerate development, reduce manufacturing costs, and de-risk scale-up.


Next Steps:


Get the 5-day CMC email course: https://smartbiotechscientist.com/#cmc


Visit the website: https://smartbiotechscientist.com


Email us: hello@bruehlmann-consulting.com

  • 21 episodes
  • Updated Thursday

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Episodes21

  • May 28 · 18 min

    256: Is Bioprocess Education Keeping Up With New Tech? The Training Gap Industry Cannot Afford to Ignore with Steffen Kreye - Part 2

    The "data lake" that was supposed to unify bioprocessing intelligence has, in most companies, become something else entirely: a data swamp, where information goes in and insight rarely comes back out. For anyone trying to deploy AI in GMP manufacturing, that is not a technical problem. It is the problem. Steffen Kreye has seen it from both sides. As former upstream development lead at Bayer and now Professor of Industrial Biotechnology at Berliner Hochschule für Technik, he brings an unusually grounded perspective on where AI in bioprocessing actually stands, what the next generation of scientists needs to be equipped with, and what industry can do right now to help close the gap. Key topics discussed: How soft skills like teamwork and self-motivation are becoming increasingly important for scientists, and strategies to foster them in education (02:47) The reality behind AI and machine learning in biotech today, including current limitations and the true state of industry adoption (05:48) Envisioning bioprocessing ten years from now: the potential of continuous manufacturing, digital twins, and automation, and the evolving diversity of bioprocesses (08:09) Practical ways industry professionals can support university education—from guest lectures to hands-on lab courses—and why it matters (10:09) Motivating students by connecting coursework to real industry roles and contributions (12:10) The importance of finding and following individual motivation in science careers (12:41) Reflections on moving from industry to academia: autonomy, challenges, and the satisfaction of seeing students grow into scientists (13:22) How strong collaboration between academia and industry leads to better innovation and prepares future scientists for success (15:53) Smart Insight: Most companies talking about AI in bioprocessing are still solving a more fundamental problem: getting their data into a state where AI could use it at all. The breakthrough will not come from the algorithm. It will come from the unglamorous, years-long work of making data accessible, harmonized, and meaningful across sites, systems, and GMP boundaries. Here are some other guests who touched on similar themes: Episodes 175 – 176 : How Virtual Reality Training Solves Europe's Bioproduction Talent Shortage with Sandrine Lemoine — about training the next generation of biopharma talent. Episodes 93 – 94: From Lab Coat to LinkedIn: Benjamin McLeod's Journey to Cell and Gene Therapy Influencer — another career pivot story from a scientist who stepped outside the traditional industry path. Episodes 111 – 112: AI Meets Biology: Why Domain Expertise Still Rules in the Age of Large Language Models with Lars Brandén — very aligned with Steffen's nuanced take that AI is a tool but human expertise in bioprocessing still matters. Connect with Steffen Kreye: LinkedIn: www.linkedin.com/in/steffen-kreye-3b531183/ Berliner Hochschule für Technik: www.prof.bht-berlin.de/kreye Next Step: If you enjoyed this episode, please leave a review on Apple Podcasts or your favorite podcast platform. By doing so, we can empower more scientists like you. Stay tuned for more inspiring biotech insights in our next episode. Support the show