Building Novo Nordisk's Biggest QC Lab in History

This week on Making It In Manufacturing, Thomas McMann sat down with Thomas Emerik Rasmussen, a project and operations leader specialising in lean manufacturing and operational excellence, with over 15 years at Novo Nordisk spanning nine different roles across Denmark, Italy and the United States, building and leading large CapEx expansion projects before moving into consulting to help companies transform their quality operations.

In this episode, Thomas covers:

• How an unconventional start as a management consultant shaped a career built on teams, mission and visible purpose
• Why the API expansion in Clayton, North Carolina, the biggest pharma investment in the world when it broke ground in 2015, became a career-defining project
• What made the 2.9 billion QC facility unique, and why stakeholder management across five different cultures proved harder than the construction itself
• How the design one, build many model cuts years off design, construction and regulatory timelines, with Fujifilm Biotechnologies cited as another adopter
• Where AI, digital twins and modular design are taking facility design next, drawing on examples shared by Roche at the ISPE conference

If you work in pharmaceutical manufacturing, operational excellence or facility design, this conversation offers a grounded look at how one of the industry's most successful scale-up stories was actually built, and where it goes from here. Worth your time from start to finish.

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Timestamps:

00:00 Introduction

01:21 Welcome to the podcast

01:34 Getting into engineering and lean manufacturing

03:31 Family, mentors and the draw to life sciences

04:50 Starting out as a management consultant

06:05 Advising medtech companies as a fresh graduate

07:08 Joining Novo Nordisk and an early promotion

09:10 Staying engaged across nine different roles

11:13 The proudest project: API expansion in Clayton, North Carolina

12:27 Relocating the family to the United States

13:17 The secret behind Novo Nordisk's growth

15:42 Scaling the business and optimising existing lines

16:04 Underestimating volumes and quadrupling API capacity

17:20 Separating operations from the CapEx organisation

19:51 The 2.9 billion QC facility and why it was unique

22:37 Innovation, automation and material handling

24:32 Project status and timeline to completion

25:21 The design one, build many model explained

27:10 The major benefits of modular design

29:13 Why more companies are adopting modular thinking

31:02 Keeping innovation alive within a standardised approach

32:37 How lean and operational excellence enable rapid expansion

34:03 Methodologies: value stream mapping

35:11 A wind turbine case study and a 25% lead time reduction

37:17 The lean mindset built into the API expansion

39:47 The biggest opportunities for innovation in facility design

41:18 Digital twins, AI and the future of facility flow

43:57 The risks around AI in design and regulation

44:57 Takeaways from the ISPE conference in the UK

45:27 Key lessons from scaling operations

48:36 The one thing he would have done differently

51:14 Closing thoughts

#MakingItInManufacturing #ARTOTalent #Pharma #PharmaceuticalManufacturing #LifeSciences #OperationalExcellence #LeanManufacturing #QualityControl #FacilityDesign #NovoNordisk #CapEx #ModularDesign

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