Making it in Manufacturing

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What does it really take to build a world-class pharmaceutical manufacturing business from the ground up while navigating risk, regulation, and rapid innovation?

This week on Making It In Manufacturing, Harry Sloan sat down with David Stevens, CEO of Kindeva, with over 20 years of experience spanning CDMO leadership, startup scale-ups, and pharmaceutical manufacturing across both Europe and the United States, including leadership roles at Kindeva and prior ventures acquired within the pharma ecosystem.

In this episode, David Stevens covers:

(00:01:02) Transitioning from startup CEO to leading Kindeva, and the strategic vision behind building advanced sterile fill-finish capabilities

(00:02:50) Scaling a biologics CDMO from zero to 250 employees during COVID, including lessons from building facilities and teams from scratch

(00:05:41) The future of inhalation technologies, including the shift to low-carbon propellants and the impact on sustainability and patient choice

(00:07:44) Designing next-generation sterile manufacturing facilities with Annex 1 compliance, advanced robotics, and contamination risk reduction

(00:09:57) Why trust, transparency, and operational discipline are critical in a competitive CDMO landscape, especially when managing capacity and client expectations

If you are working in pharmaceutical manufacturing, CDMO strategy, or scaling complex life sciences operations, this conversation offers a grounded perspective on leadership, growth, and building for long-term impact.

Follow ARTO

LinkedIn: https://www.linkedin.com/company/artotalent

Spotify: https://open.spotify.com/show/0kEcRZOiJChOoN1KF2n1ng

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Apple Podcasts: https://podcasts.apple.com/us/podcast/leading-beyond-the-lab/id1783115575

Website: https://arto-talent.com/

Youtube: https://www.youtube.com/@artotalent

David Stevens

LinkedIn: https://www.linkedin.com/in/davecstevens/

Harry Sloan

LinkedIn: https://www.linkedin.com/in/harry-sloan-605620154/

Timestamps:

00:00 Introduction

00:14 Guest introduction and CEO journey

01:02 Career background and move into @Kindeva

02:50 Building and scaling a biologics CDMO

05:41 Vision for inhalation technology and sustainability

07:44 Future of sterile manufacturing and facility design

09:57 Trust and partnerships in CDMO relationships

12:12 Managing growth, capacity, and reputation

12:36 Long-term vision and defining success as CEO

#MakingItInManufacturing #ARTOTalent #PharmaceuticalManufacturing #CDMO #Biologics #LifeSciences #ManufacturingLeadership

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What does it really take to move from science into CEO leadership while delivering real impact for patients?

This week on Making It In Manufacturing, Harry Sloan sat down with Dr Adriana Kiedzierska-Mencfeld, CEO of Rezon Bio, with 20 years of experience spanning biotech, biologics manufacturing, and leadership across industry and scientific roles.

In this episode, Dr Adriana Kiedzierska-Mencfeld covers:

- Transitioning from academia to industry and the drive to turn science into real patient value

- Key leadership moments including entering new technology areas and managing high-pressure decision making

- Leading through COVID, maintaining operations, and ensuring both product delivery and team safety

- Transforming into a CDMO model and leading organisational change with clarity and purpose

- Competing in a crowded CDMO market through cost discipline, quality standards, and operational efficiency

If you are working in biotech, manufacturing, or scaling scientific innovation into real-world impact, this conversation offers a clear and grounded perspective on leadership, decision making, and building high-performing teams under pressure.

Follow ARTO

LinkedIn: https://www.linkedin.com/company/artotalent

Spotify: https://open.spotify.com/show/0kEcRZOiJChOoN1KF2n1ng

Instagram: https://www.instagram.com/arto.talent?igsh=MWdhbWl5N204a253NQ%3D%3D&utm_source=qr

TikTok: https://www.tiktok.com/@artotalent?_t=ZG-8tHbGACAZaj&_r=1

Apple Podcasts: https://podcasts.apple.com/us/podcast/leading-beyond-the-lab/id1783115575

Website: https://arto-talent.com/

Youtube: https://www.youtube.com/@artotalent

Dr Adriana Kiedzierska-Mencfeld

LinkedIn: https://www.linkedin.com/in/dr-adriana-kiedzierska-mencfeld/

Harry Sloan

LinkedIn: https://www.linkedin.com/in/harry-sloan-605620154/

Timestamps:

00:00 Introduction

00:33 Moving beyond science into leadership

02:06 Career-defining moments and leadership growth

04:56 Leading through COVID and regulatory pressure

06:01 FDA inspection and managing high-stakes environments

07:13 Transition to CDMO and company transformation

09:20 Launch of Resins Bio and stepping into CEO role

11:39 Building trust and delivering for clients

12:29 Cost competitiveness and market positioning

14:20 Speed, quality, and CDMO differentiation

15:22 Market trends and opportunities in biologics

17:33 CDMO positioning and capabilities

18:09 Balancing existing clients and new business

20:08 Personal career journey and challenges

21:44 Advice for women in biotech leadership

22:46 Future of biologics manufacturing

24:33 Motivation and leadership purpose

#MakingItInManufacturing #ARTOTalent #Biotech #CDMO #Biologics #LifeSciences #ManufacturingLeadership

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What if you could access GMP manufacturing without giving up control, ownership, or flexibility? In this episode, a new model challenges how biotech companies think about scaling.

This week on Making It In Manufacturing, Harry Sloan sat down with Sarah Stevens, CEO of Chrysalis, with over 20 years of experience spanning CDMO services, technical operations, and leadership roles across biopharma manufacturing.

In this episode, Sarah Stevens covers:

(00:00) How Chrysalis is redefining the CDMO model with a hybrid approach that allows companies to retain control of IP, timelines, and manufacturing processes

(02:20) Why today’s biotech environment demands more flexible, cost-conscious manufacturing strategies and how companies can better manage capital allocation

(04:25) Where biotech companies get manufacturing strategy wrong when balancing speed versus long-term scalability in GMP processes

(08:57) A 20-year career journey from academic research into executive leadership and what drives success in CDMO environments

(13:21) How Chrysalis evolved its model into a scalable and mobile platform, enabling customers to transition seamlessly into their own facilities

If you are navigating manufacturing strategy, scaling operations, or evaluating CDMO partnerships, this episode offers a clear perspective on how to approach flexibility, control, and long-term success in biopharma.

Follow ARTO

LinkedIn: https://www.linkedin.com/company/artotalent

Spotify: https://open.spotify.com/show/0kEcRZOiJChOoN1KF2n1ng

Instagram: https://www.instagram.com/arto.talent?igsh=MWdhbWl5N204a253NQ%3D%3D&utm_source=qr

TikTok: https://www.tiktok.com/@artotalent?_t=ZG-8tHbGACAZaj&_r=1

Apple Podcasts: https://podcasts.apple.com/us/podcast/leading-beyond-the-lab/id1783115575

Website: https://arto-talent.com/

Youtube: https://www.youtube.com/@life_sciences

Sarah Stevens

LinkedIn: https://www.linkedin.com/in/sarah-stevens-1135964

Harry Sloan

LinkedIn: https://www.linkedin.com/in/harry-sloan-605620154/

#MakingItInManufacturing #ARTOTalent #Biopharma #CDMO #GMP #BiotechManufacturing #LifeSciences

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How do you bring a $400M biotech facility online… without getting automation wrong?

This week, in another episode of Making It in Manufacturing, we feature Daniel Shearer, Head of Automation at FUJIFILM, with over 15+ years of experience spanning automation engineering, capital projects, and large-scale biotech manufacturing environments.

In this episode, Dan covers:

- The $400M multi-modal manufacturing asset at Fujifilm’s Billingham site and what it takes to bring it online

- How automation has evolved over the past decade and why data integration is now critical

- The importance of standardisation, and how it can reduce cost, validation time, and complexity

- Integration challenges across systems like MES, LIMS, and quality platforms

- The most common pitfalls in automation projects, and how to avoid them

Whether you're building a new facility or scaling existing operations, this episode is packed with practical insights from someone working at the forefront of modern biomanufacturing.

👉 Be sure to check out the full episode and learn how to get automation right from day one.

Follow ARTO

LinkedIn: https://www.linkedin.com/company/artotalent/?viewAsMember=true

Spotify: https://open.spotify.com/show/0kEcRZO...

Instagram: https://www.instagram.com/arto.talent...

TikTok: https://www.tiktok.com/@artotalent?_t...

Apple Podcasts: https://podcasts.apple.com/us/podcast...

Website: https://arto-talent.com

Youtube: https://www.youtube.com/@artotalent

Daniel Shearer

Head of Automation at FUJIFILM Biotechnologies

LinkedIn: https://www.linkedin.com/in/daniel-shearer-80574b36/

Thomas McMann

Director - Contracts Division

LinkedIn: https://www.linkedin.com/in/thomas-mcmann-05540a10b/

Timestamps:

00:24 $400M Multi-Modal Asset

01:38 Automation Challenges

06:59 Standardisation

11:18 Integration + Common Pitfalls

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Building a CDMO capable of taking therapies from early discovery to commercial supply requires more than scale. It requires scientific depth, operational discipline and a culture that embraces problems rather than avoids them.

This week on Making It In Manufacturing, Harry Sloan sat down with Philippe Clavel, CEO of Curapath, bringing decades of experience across pharmaceutical manufacturing, leadership and CDMO strategy.

In this episode, Philippe Clavel covers:

• The evolution of CuraPath from a university spin-off focused on polymer science to a drug delivery CDMO serving biotech and large pharmaceutical companies (00:00)

• Why deep scientific expertise in polymer science and lipid nanoparticles is essential for solving complex drug delivery challenges and improving manufacturing processes (02:29)

• How CuraPath transitioned from early-stage discovery work to commercial manufacturing, growing from 0% commercial revenue to roughly 30% within five years (05:14)

• The operational realities of scaling into GMP manufacturing, including building robust processes, documentation and training across the organisation (10:12)

• Why successful CDMO partnerships are built on trust, technical questioning and understanding the deeper motivations behind a customer’s drug development programme (17:00)

If you’re interested in the realities of scaling a specialist CDMO, building high-trust biotech partnerships and transforming scientific innovation into manufacturable therapies, this conversation offers valuable insight from someone leading that journey firsthand.

Follow ARTO

LinkedIn: / artotalent

Spotify: https://open.spotify.com/show/0kEcRZO...

Instagram: https://www.instagram.com/arto.talent...

TikTok: https://www.tiktok.com/@artotalent?_t...

Apple Podcasts: https://podcasts.apple.com/us/podcast...

Website: https://arto-talent.com/

Youtube: @life_sciences

Philippe Clavel

LinkedIn: / philippe-clavel-cdmo-gxapis

Harry Sloan

/ harry-sloan-605620154

Timestamps

00:00 Introduction

00:17 Overview of CuraPath and its drug delivery focus

02:29 What differentiates CuraPath as a CDMO

04:00 Balancing cost, scalability and complex modalities

05:14 Growth from discovery projects to commercial manufacturing

06:10 Expanding expertise from polymers to lipid nanoparticle technologies

07:41 Supporting customers across the full development journey

09:21 The significance of delivering a therapy reaching the market

10:12 Transitioning to GMP manufacturing and operational discipline

11:34 Challenges that come with scaling CDMO operations

13:27 Building a culture that embraces problems and deviations

15:27 Understanding customer motivations and building trust

18:24 Collaboration across supply chains within drug manufacturing

21:17 Maintaining company culture while scaling leadership

23:32 Encouraging challenge and empowerment within teams

27:13 Advice for business development professionals in CDMO

31:08 Future outlook for CuraPath and its pipeline

34:25 Personal motivation behind leading the company

39:02 Episode closing

#MakingItInManufacturing #ARTOTalent #CDMO #PharmaceuticalManufacturing #DrugDelivery #Biotech #LifeSciences

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What does it take to standardise an entire industry, and keep pace with AI, cloud, and digital transformation?

This week on Making It in Manufacturing, we feature Thana Subramanian, GAMP Global Steering Committee Co-Chair, with over 32 years of experience in idustry, with 25 years as an ISPE member and 15 years as part of the GAMP CoP.

In this episode, Thana covers:

- The history and purpose of ISPE and its role in advancing pharmaceutical manufacturing

- How GAMP evolved alongside regulatory bodies like the FDA and EMA

- The benefits of ISPE membership, from networking to access to global best practices

- The origins and evolution of GAMP, from early guidance to modern AI-driven systems

- The objectives and key themes of the latest GAMP UK Conference, including AI, digital validation, and data integrity

If you’re working in pharma, biotech, or advanced manufacturing, this episode gives you a clear lens into how global standards are shaped — and where the industry is heading next.

Be sure to check out the full episode.

Follow ARTO

LinkedIn: https://www.linkedin.com/company/artotalent/?viewAsMember=true

Spotify: https://open.spotify.com/show/0kEcRZO...

Instagram: https://www.instagram.com/arto.talent...

TikTok: https://www.tiktok.com/@artotalent?_t...

Apple Podcasts: https://podcasts.apple.com/us/podcast...

Website: https://arto-talent.com

Youtube: https://www.youtube.com/@artotalent

Thana Subramanian

GAMP Global Steering Committee Co-Chair

LinkedIn: https://www.linkedin.com/in/thanasubramanian/

Thomas McMann

Director - Contracts Division

LinkedIn: https://www.linkedin.com/in/thomas-mcmann-05540a10b/

Timestamps:

00:27 ISPE History

02:33 GAMP New Good Practice Guide (GxP Process Control Systems) Third Edition

07:32 Benefits of ISPE and GAMP

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What does it take to turn around a global antibiotic manufacturer and redefine its future in one of the toughest market environments in Europe?

This week, in another episode of the Making It in Manufacturing Spotlight Series, hosted by @Thomas McMann we sit down with @Michael Kocher, CEO of @Xellia, who brings over two decades of leadership experience across global pharma and large-scale operations. With a career spanning senior roles in big-pharma and now leading a globally influential API manufacturer, Michael shares a remarkably honest look at the realities, decisions, and opportunities shaping Xellia today.

In this episode, Michael covers:

- Surprises from his first two years as CEO, including the talent, mindset, and culture he found inside Xellia.

- His early strategic focuses, stabilising finances, divesting business operations, and rebuilding a sustainable foundation.

- Xellia’s key differentiators, its portfolio of anti-infectives, their role in fighting severe infections and AMR.

- The decision to close its Copenhagen manufacturing site over 8-10 years, why the long-term shift was necessary and how it impacts future manufacturing.

- European policy and market pressures, reimbursement challenges, OPEX subsidies, and why reshoring isn’t realistic.

- Future priorities, financial strengthening, product transfers, market-share growth, and new product launches.

- Biggest opportunities ahead, expanding the fermentation-based API portfolio and doubling down on critical medicines. Full Podcast

Be sure to check out this episode to hear Michael’s candid perspective on leadership, manufacturing, European policy, and what it truly takes to win in today’s API landscape.

Follow ARTO:

LinkedIn: https://www.linkedin.com/company/artotalent

Spotify: https://open.spotify.com/show/0kEcRZOiJChOoN1KF2n1ng

Instagram: https://www.instagram.com/arto.talent?igsh=MWdhbWl5N204a253NQ%3D%3D&utm_source=qr

TikTok: https://www.tiktok.com/@artotalent?_t=ZG-8tHbGACAZaj&_r=1

Apple Podcasts: https://podcasts.apple.com/us/podcast/leading-beyond-the-lab/id1783115575

Website: https://arto-talent.com/

YouTube: https://www.youtube.com/@life_sciences

Michael Kocher

CEO at Xellia Pharmaceuticals

LinkedIn: https://www.linkedin.com/in/michael-kocher-191863a/

Thomas McMann

Director - Contracts Division

LinkedIn: https://www.linkedin.com/in/thomas-mcmann-05540a10b/

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What does it really take to scale pharmaceutical manufacturing globally, without losing sight of patients?

In this standout episode of Making It in Manufacturing, we sit down with Preben Haaning, Board Member at Xellia Pharmaceuticals, and a global pharmaceutical executive with 25+ years of experience spanning sales, finance, site leadership, and board-level strategy.

Preben shares lessons from an extraordinary career: including his pivotal years at Novo Nordisk, where he helped scale global manufacturing networks and supported the early foundations of today’s GLP-1 supply chain.

In this episode, Preben covers:

• How Xellia Pharmaceuticals is scaling critical anti-infectives while maintaining reliable global supply

• His unconventional journey from the military into life sciences leadership, and what it taught him about resilience and decision-making

• Real-world examples of project success and failure, including moments where patient access was directly at risk

• What it’s like operating as a global pharmaceutical executive, managing multi-site, multi-culture manufacturing networks

• Inside Novo Nordisk’s US expansion, including the launch of its first US-produced drug and early GLP-1 manufacturing challenges

If you’re working in pharmaceutical manufacturing, engineering, operations, or leadership, this is an episode packed with hard-won insight from the front lines.

👉 Be sure to check out the full episode and subscribe for more conversations with the leaders shaping life-sciences manufacturing.

Follow ARTO

LinkedIn:   / artotalent  

Spotify: https://open.spotify.com/show/0kEcRZO...

Instagram: https://www.instagram.com/arto.talent...

TikTok: https://www.tiktok.com/@artotalent?_t...

Apple Podcasts: https://podcasts.apple.com/us/podcast...

Website: https://arto-talent.com

Youtube:    / @life_sciences  

Preben Haaning

Board Member at Xellia Pharmaceuticals

LinkedIn:   / preben-haaning-18a6193  

Thomas McMann

Director - Contracts Division

LinkedIn:   / thomas-mcmann-05540a10b  

Timestamps:

02:03 Xellia Pharmaceuticals

11:07 From the Military to Life Sciences

19:11 Project Success and Failure

28:51 Global Pharmaceutical Executive

46:41 Novo Nordisk Expansion of US Supply

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What does it take to step into a publicly listed CDMO and immediately reposition it for growth in a shifting global market? At Mabion, it starts with people, scientific excellence and a clear commercial vision.

This week on Making It In Manufacturing, Thomas McMann sat down with Gregor Kawaletz, CEO of Mabion, bringing over 20 years of experience in the CDMO space spanning leadership roles across NextPharma, Catalent and Recipharm. Now in the first month as CEO, Gregor shares why this move was about broader impact and how the organisation will be steered into its next phase.

In this episode, Gregor covers:

• The first month as CEO at @Mabion and why “every company is about people”

• The transition from Chief Commercial Officer roles into a CEO position with responsibility for the full organisation

• Growth priorities, pipeline confidence and an upcoming adjusted business model

• The €500,000 innovation initiative and awarding @WPD for novel antibody drug conjugate programmes in oncology

• Regulatory shifts in the biosimilar space and how reduced requirements are expanding patient access

The conversation also explores operating in a more multipolar global environment and why CDMOs must move beyond traditional fee-for-service models toward deeper collaboration and network thinking.

For professionals in biologics, biosimilars or CDMO partnerships, this episode offers strategic insight shaped by experience across NextPharma, Catalent, Recipharm and now at Mabion.

Check out this episode to hear how scientific depth, commercial leadership and organisational alignment can reposition a CDMO for long-term success.

Follow ARTO

LinkedIn: https://www.linkedin.com/company/artotalent

Spotify: https://open.spotify.com/show/0kEcRZOiJChOoN1KF2n1ng

Instagram: https://www.instagram.com/arto.talent?igsh=MWdhbWl5N204a253NQ%3D%3D&utm_source=qr

TikTok: https://www.tiktok.com/@artotalent?_t=ZG-8tHbGACAZaj&_r=1

Apple Podcasts: https://podcasts.apple.com/us/podcast/leading-beyond-the-lab/id1783115575

Website: https://arto-talent.com/

Youtube: https://www.youtube.com/@life_sciences

Gregor Kawaletz - CEO at Mabion

LinkedIn: https://www.linkedin.com/in/gregor-kawaletz-276a4830/

Thomas McMann - Director At ARTO

LinkedIn: https://www.linkedin.com/in/thomas-mcmann-05540a10b/

Timestamps:

00:00 First month as CEO at Mabion

02:19 Two decades in the CDMO space including NextPharma, Catalent and Recipharm

02:42 Moving from CCO to CEO

05:10 Growth strategy and business model evolution

06:57 €500k innovation award and WPD

09:41 Biosimilars regulation and market access

11:04 Navigating a multipolar global supply landscape

12:47 Expanding Mabion’s future offering

#MakingItInManufacturing #ARTOTalent #CDMO #Biologics #Biosimilars #LifeSciences #ManufacturingLeadership

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What does it really take to build trust in pharmaceutical and biotech partnerships when timelines are tight, expectations are high, and the market never stands still?

This week on Making It In Manufacturing, Tom McMann sat down with Alexander Schäfer, Business Development Manager, to unpack what strong execution, honest communication, and long-term thinking look like inside global contract packaging services.

In this episode, Alexander shares insights from his work across European operations in pharmaceutical and biotech packaging, supporting everyone from early-stage virtual biotechs to established blue-chip pharma organisations. Speaking from the floor of CPHI, one of the industry’s most important global events, he breaks down how expectations shift across company sizes and why trust is earned through delivery, not promises.

Throughout the conversation, Alexander references the realities of operating at scale within global packaging services, the importance of listening to market demand, and how investment decisions are shaped by customer needs and long-term industry trends.

In this episode, Alexander Schäfer covers:

• How servicing small biotechs versus large pharma companies requires different approaches to expectations and support (01:28)

• Why trust in business development is built through execution, consistency, and reputation over time (03:12)

• The importance of open communication and solution-led thinking when projects face challenges (04:24)

• What skills matter most in business development, including listening, asking the right questions, and understanding customer pain points (06:29)

• How major investments into packaging capacity, injectables, and device assembly are shaping the future of the industry (07:21)

This conversation was recorded during CPHI, where industry leaders come together to discuss innovation, investment, and the future of pharmaceutical manufacturing. It offers a grounded look at how business development works behind the scenes in a highly regulated, fast-moving environment.

If you are working in pharma, biotech, manufacturing, or commercial leadership, this episode offers practical insight into how long-term partnerships are built and sustained.

Check out the full episode now.

Follow ARTO

LinkedIn: https://www.linkedin.com/company/artotalent

Spotify: https://open.spotify.com/show/0kEcRZOiJChOoN1KF2n1ng

Instagram: https://www.instagram.com/arto.talent?igsh=MWdhbWl5N204a253NQ%3D%3D&utm_source=qr

TikTok: https://www.tiktok.com/@artotalent?_t=ZG-8tHbGACAZaj&_r=1

Apple Podcasts: https://podcasts.apple.com/us/podcast/leading-beyond-the-lab/id1783115575

Website: https://arto-talent.com/

YouTube: https://www.youtube.com/@life_sciences

Alexander Schäfer

LinkedIn: https://www.linkedin.com/in/alexander-sch%C3%A4fer-4515a433/

Tom McMann

LinkedIn: https://www.linkedin.com/in/thomas-mcmann-05540a10b/

Timestamps:

00:00 Introduction and context from CPHI

00:54 Overview of European operations and contract packaging services

01:28 Servicing biotech versus pharma clients

03:12 Building trust through execution and reputation

04:24 Managing challenges with open communication and solutions

06:29 Essential skills for business development professionals

07:21 Investment in injectables, devices, and future capacity

10:25 Closing reflections

#MakingItInManufacturing #ARTOTalent #PharmaManufacturing #Biotech #BusinessDevelopment #CPHI #ContractPackaging

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