Smart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders
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:
Visit the Website: https://smartbiotechscientist.com
Email us: hello@bruehlmann-consulting.com
Smart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders
248: Nitrosamine Risk Assessment and CRO Selection: The $6 Million Mistake CMC Teams Must Avoid with Ron Najafi - Part 2
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Getting an NDA signed shouldn't take weeks. If your CRO needs more than 48 hours to start the paperwork, your project timeline is already moving in the wrong direction.
Ron Najafi knows what rigorous analytical work actually looks like under pressure. As founder and CEO of Emery Pharma, he led the investigation that identified NDMA as a degradation product of ranitidine — findings the FDA formally validated and that reshaped how the industry approaches nitrosamine risk assessment. In Part 2, he moves from that scientific foundation into the operational questions that determine whether a CRO partnership accelerates your program or quietly slows it down.
If you haven't heard Part 1, it covers Ron's career arc and the technical details of nitrosamine contamination in pharmaceutical development. This episode stands on its own for anyone focused on CRO selection, bioanalytical strategy, and what three decades of building analytical companies actually teaches you.
Topics discussed:
- How to tell if a CRO’s workflow is robust—or just rigid (05:51)
- The importance of method validation and product stability testing (07:27)
- Managing expectations and trust-building in client relationships (08:29)
- Entrepreneurial lessons: raising capital, team-building, and finding the right partners (10:00)
- The hidden costs of public vs. private biotech ventures (12:31)
- Reducing bioanalytical costs in biologics through mass spectrometry (13:23)
- The future of analytical workflows and personalized medicine (14:48)
Smart insight:
In biotech, success isn’t just about the science—it’s about strategic discipline. Ron emphasizes a few hard-earned principles: raise more capital than you think you’ll need, don’t fixate on valuation, and invest in smart, creative talent. Just as important, real value is unlocked through strong partnerships and the ability to manage collaborations and acquisitions with intention.
If this topic resonates with you, here are a few related episodes on building strong CMC foundations and avoiding costly development mistakes:
- Episodes 231 - 232: From IND to BLA: The Biologics CMC Decisions That Determine Regulatory Success with Henri Kornmann
- Episodes 203 - 204: Mastering CRO Selection: Essential Questions for CMC Analytical Development with Daniel Galbraith
- Episodes 199 - 200: Mastering Quality by Design: From Product Failures to Commercial Success in Biologics CMC Development
- Episodes 189 - 190: Why Smart Biotech Founders Plan CMC First (While Competitors Burn Cash Later)
- Episodes 139 - 140: Regulatory Secrets Revealed: Why Your CMC Strategy Could Make or Break Your Biotech Startup with Rivka Zaibel
- Episodes 57 - 58: Crafting a Solid CMC Strategy: Key Factors and Common Pitfalls with Matthias Müllner
- Episodes 23 - 24: Strategies for Success: Master CMC Development with Gene Lee
Connect with Ron Najafi:
LinkedIn: www.linkedin.com/in/ronnajafi
Emery Pharma: www.emerypharma.com