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

Hosted on Acast. See acast.com/privacy for more information.

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

Hosted on Acast. See acast.com/privacy for more information.

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

Hosted on Acast. See acast.com/privacy for more information.

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/

Hosted on Acast. See acast.com/privacy for more information.

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

Hosted on Acast. See acast.com/privacy for more information.

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

Hosted on Acast. See acast.com/privacy for more information.

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

Hosted on Acast. See acast.com/privacy for more information.

This week, in another episode of the Making it in Manufacturing Spotlight Series, we sit down with Ankit Gupta, CEO of Instapill, a company redefining oral drug delivery through freeze-dried, fast-dissolving tablets.

With over 15 years of experience spanning investment banking, M&A, and leadership roles in pharmaceutical manufacturing, Ankit brings a sharp perspective on scaling, innovation, and sustainable differentiation.

In this episode, Ankit covers:

• Instapill’s unique FDA-approved non-gelatin ODT technology and why it’s transforming patient outcomes in paediatrics and geriatrics.
• Scaling up manufacturing capacity in India and future expansion plans into the US, and how automation will maintain quality at scale.
• How digital transformation and AI are shaping pharmaceutical manufacturing, from paperless R&D to data-driven precision in production.
• What makes a CDMO attractive to investors, and how sustainable differentiation trumps trend-driven momentum.
• Lessons from M&A and investment banking, and how they inform his approach as a CEO leading growth in a competitive CDMO landscape.

Be sure to check out this episode to hear how Instapill is not only innovating formulation, but reimagining the future of pharma manufacturing.

To listen to (or watch) the full episode, search "Making it in Manufacturing Instapill" on your preferred streaming platform. Or, click on the first link in the comments below.

Follow ARTO

LinkedIn: https://www.linkedin.com/company/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: https://www.youtube.com/@life_sciences

Ankit Gupta

CEO at Instapill

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

Thomas McMann

Director - Contracts Division

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

Timestamps:

00:11 Stand Out FDA Approval & Speed to Market

08:00 Global Growth and Operations

10:55 Insights & Leadership Takeaways

Hosted on Acast. See acast.com/privacy for more information.

This week, in another episode of the Making It in Manufacturing Spotlight Series, we sit down with Himanshu Gadgil, PhD, CEO of Enzene. With over a decade of experience spanning scientific innovation, biologics development & manufacturing, global expansion and CDMO leadership, Himanshu shares the story behind Enzene’s rise from a small R&D biotech in India to a rapidly scaling global CIDMO with newly established US manufacturing.

In this episode, Himanshu covers:

- How Enzene built and evolved its first-in-class, fully-connected continuous manufacturing platform, EnzeneX - including initial failures shaped breakthrough innovation.

- Why fully-connected continuous manufacturing™ is a cost and efficiency game-changer for biologics.

- The regulatory and operational challenges of scaling this technology - and how Enzene approached India-to-US expansion.

- Leadership lessons in his progression from scientist to CEO, including culture, resilience, and recognising that success depends on the combination of transformative innovation with a unique values/mission-driven approach to the way business gets done.

- The future of biomanufacturing - from localisation and personalised production to fully automated, analytics-driven systems.

Be sure to check out this episode to hear how Enzene is redefining what a modern CDMO can be.

To listen to (or watch) the full episode, search "Making it in Manufacturing Enzene" on your preferred streaming platform, or click on the first link in the comments below.

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

Himanshu Gadgil

CEO of Enzene

LinkedIn: https://www.linkedin.com/in/himanshu-gadgil-3326307/

Thomas McMann

Director - Contracts Division

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

Timestamps:

00:10 Enzene's Vision

04:10 Building & Scaling a Global Platform

07:51 Enzene's Competitive Edge

14:56 The Future of CDMO's

21:01 Vision for Enzene's Future Growth

Hosted on Acast. See acast.com/privacy for more information.

This week, in another episode of the Making It in Manufacturing Spotlight Series, hosted by Thomas McMann, we sit down with Dirk T. Lange, CEO at Pyramid Pharma Services. With 30 years of experience across drug-substance and drug-product CDMOs, global operations, outsourcing leadership, and life-science services, spanning Rentschler, KBI Biopharma, Novartis, Sandoz, and more, Dirk brings a rare dual-lens perspective from both the provider and sponsor side.

In this episode, Dirk covers:

- A full overview of Pyramid Pharma Services, a 37-year-old CDMO with an exceptionally broad drug-product offering from clinical to commercial supply.

- Key data behind Pyramid’s under-the-radar growth, including 15 successful FDA inspections, a strong legacy of quality, and decades of organic expansion driven by long-term customer partnerships.

- Why they’re doubling their fill–finish capabilities, including the strategic drivers, client demand, and the transition from clinical-scale to high-speed commercial lines.

- The operational realities of scaling, from maintaining culture to onboarding new teams, strengthening processes, and preserving execution excellence during rapid growth.

- How Pyramid positions itself as an enabler in the supply chain, supporting customers from early development through long-term commercial supply.

Be sure to check out this episode, a deep dive into what it really takes to scale a legacy CDMO while protecting quality, culture, and customer trust.

To listen to (or watch) the full episode, search "Making it in Manufacturing Pyramid Pharma" on your preferred streaming platform, or click on the first link in the comments below.

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

Dirk T. Lange

CEO at Pyramid Pharma Services

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

Thomas McMann

Director - Contracts Division

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

Timestamps:

00:11 Pyramid Overview

01:41 Key Data

03:46 Doubling Fill Finish Capabilities

05:38 Growth Challenges

Hosted on Acast. See acast.com/privacy for more information.

With over 12 months in the CCO role and extensive experience across the CDMO space, Raj brings insight from leading business development, project management, and commercial strategy across both life science/diagnostics and aseptic drug-product services.

In this episode, Raj covers:

- Why Argonaut chooses to support “N of 1” programmes, and the cultural impact of delivering life-saving therapies for single-patient treatments.

- The operational challenges of ultra-high-value API filling, and how Argonaut minimises line losses for rare-disease therapies.

- The company’s evolution, from diagnostics to becoming a major player in small- to mid-scale aseptic drug-product manufacturing.

- How Argonaut’s new $45M facility and commercial-scale filling line will transform output, enable prefilled syringes/cartridges, and support global demand.

- The realities of scaling a CDMO, including hiring, maintaining culture, preparing for FDA pre-approval inspection, and setting long-term strategy for future capabilities.

Be sure to check out this episode to hear Raj’s candid take on growth, culture, and the future of drug-product manufacturing.

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

Raj Puri

CCO at Argonaut Manufacturing Services

LinkedIn: https://www.linkedin.com/in/raj-puri-3137665/

Thomas McMann

Director - Contracts Division at ARTO

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

Timestamps:

00:10 Stepping Into The Role & Early Lessons

04:03 Scaling Smart: Challenges and Capabilities

09:07 Culture, Talent & The Future

Hosted on Acast. See acast.com/privacy for more information.

This week, in another episode of the Making it in Manufacturing Spotlight Series, we sit down with Ankit Gupta, CEO of Instapill, a company redefining oral drug delivery through freeze-dried, fast-dissolving tablets.

With over 15 years of experience spanning investment banking, M&A, and leadership roles in pharmaceutical manufacturing, Ankit brings a sharp perspective on scaling, innovation, and sustainable differentiation.

In this episode, Ankit covers:

- Instapill’s unique FDA-approved non-gelatin ODT technology and why it’s transforming patient outcomes in paediatrics and geriatrics.

- Scaling up manufacturing capacity in India and future expansion plans into the US, and how automation will maintain quality at scale.

- How digital transformation and AI are shaping pharmaceutical manufacturing, from paperless R&D to data-driven precision in production.

- What makes a CDMO attractive to investors, and how sustainable differentiation trumps trend-driven momentum.

- Lessons from M&A and investment banking, and how they inform his approach as a CEO leading growth in a competitive CDMO landscape.

Be sure to check out this episode to hear how Instapill is not only innovating formulation, but reimagining the future of pharma manufacturing.

To listen to (or watch) the full episode, search "Making it in Manufacturing Instapill" on your preferred streaming platform. Or, click on the first link in the comments below.

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

Ankit Gupta

CEO at Instapill

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

Thomas McMann

Director - Contracts Division

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

Timestamps:

00:11 Stand Out FDA Approval & Speed to Market

08:00 Global Growth and Operations

10:55 Insights & Leadership Takeaways

Hosted on Acast. See acast.com/privacy for more information.

This week, in another episode of the Making It in Manufacturing Spotlight Series, we sit down with Hanns-Christian Mahler, CEO & Founder of ten23.

With over 20 years of experience spanning senior roles at Merck, Roche, biopharma development, drug-product strategy, and CDMO leadership, Hanns-Christian brings a rare blend of scientific rigour, sustainability vision, and people-centric leadership.

In this episode, Hanns-Christian covers:

- The origin story of ten23 and why he left big pharma to challenge the CDMO status quo with ten23

- Why ten23 leads with partnership - not execution - and how “asking better questions” is their competitive edge ten23

- ten23’s rapid growth journey: new filling lines, site expansion, headcount growth, and strategic partnerships, like with BD

- The culture behind the company: transparency, autonomy, values-led leadership, and building a truly learning organisation at ten23

- The future of CDMOs: AI adoption with intention, sustainability as a scientific discipline, and what’s next for ten23’s global footprint

- Hanns-Christian also speaks about his partnerships with sustainability-focused companies such as Lio, led by CEO Vladimir Keil, highlighting how these collaborations help drive more responsible and efficient operations.

If you want a masterclass in modern CDMO leadership, rooted in science, innovation, and purpose, this is the episode to watch.

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

Hanns-Christian Mahler

CEO at ten23

LinkedIn: https://www.linkedin.com/in/hanns-christian-mahler/

Thomas McMann

Director - Contracts Division at ARTO

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

Timestamps:

00:00 Career Beginnings & ten23

08:18 Challenges with Scaling

14:29 Culture & Leadership Style

20:00 Scientific Rigour vs Sustainability

26:07 Challenges with Geopolitical Issues

29:13 The Future & AI

Hosted on Acast. See acast.com/privacy for more information.

This week, we kick off Season 2 of Making It In Manufacturing with a heavyweight guest: J.D. Mowery, Division President, CDMO at Bora Pharmaceuticals. With more than 25 years of experience across the biopharmaceutical and CDMO sectors, J.D. brings a proven track record of building high-performing teams, scaling operations, and driving innovation at every stage of the drug development lifecycle. He has held impactful leadership roles at industry leaders such as Genentech, Lonza, and JSR Life Sciences, and most recently served as CEO of KBI Biopharma. His expertise spans operations, manufacturing, technology transfer, facility construction, and business development, with a global perspective shaped by work across North America, Europe, and Asia. J.D. is known for his hands-on leadership style, commitment to operational excellence, and passion for building strong, collaborative cultures.

In this episode, J.D. unpacks:

- Smart integration and scaling: Integration and scaling of sites post-acquisition

- Why quality is still the sharpest competitive edge

- What it means to partner with purpose in today’s pharma landscape

- Where CDMOs are headed next - and how AI is shaping that direction

If you're in a leadership role within pharma or biotech, this is the episode you’ll want your entire team to hear.

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

J.D. Mowery

Division President - CDMO

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

Thomas McMann

Director - Contracts Division at ARTO

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

Timestamps:

00:00 Filling Sites & Scaling Smartly

06:38 Quality as a Differentiator

13:30 Partnering with Purpose

17:19 The Future of CDMOs and AI

Hosted on Acast. See acast.com/privacy for more information.

• He oversees the end-to-end design and delivery of GMP-compliant manufacturing facilities for APIs, peptides, and oligonucleotides, combining technical depth with strategic execution.
• With over 20 years of experience in pharmaceutical and biotech engineering, Abbas has led major capital projects across global markets.
• His career includes an extensive tenure at Sanofi, where he held senior roles in process engineering, project delivery, and technology transfer.
• A regular speaker on the international stage, Abbas most recently represented EUROAPI at the 2025 ISPE Europe Annual Conference in London.

In this episode, we cover a range of topics including Culture, CAPEX, Project Planning & Delays, Sustainability, AI, Quickfire Questions and a lot more. This conversation applies broadly to all types of connections in the Life Sciences Industry, and aims to educate and inspire those who want to excel in the manufacturing and engineering space.

Follow ARTO

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

Spotify: Leading Beyond The Lab

Instagram: Instagram (@arto.talent)

TikTok: artotalent on TikTok

Apple Podcasts: Leading Beyond The Lab

Website: Home

Youtube: ARTO Recruitment\

Abbas Hussain

Projects & Engineering Manager at EUROAPI.

LinkedIn: https://www.linkedin.com/in/abbas-sayyed-028a7812/

Thomas McMann

Director - Contracts Division at ARTO

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

Timestamps:

00:00 Career Beginnings

08:31 Culture Differences

16:58 CAPEX, Project Planning & Delays

30:42 Sustainability

36:54 AI & Rounding Up

#MakingItInManufacturing #ARTOTalent #ManufacturingAndEngineering #ISPE #AI #OPEX #CDMOS #DataIntegrity #Auditing #CSV #CAPEX #Sustainability

Hosted on Acast. See acast.com/privacy for more information.

• Currently Manager, Manufacturing Technology at Incyte (since 2021), leading cleaning process development and validation at Incyte’s biologics manufacturing site in Switzerland.
• Brings nearly 20 years of experience in biopharma manufacturing, specialising in cleaning processes, cleaning validation, tech transfer, continuous improvement, and CAPEX in multi‑product environments.
• Spent over a decade as a consultant - serving as Senior Consultant with GxP Consulting Switzerland, and holding senior C&Q/validation roles at Novartis, MSD, Biogen, Pfizer, and Dako.
• A recognised ISPE speaker, Michael shares his expertise on large stages including ISPE conferences, engaging global audiences on biopharma manufacturing best practices.

In this episode, we cover a range of topics including Michael’s Career Beginnings, Cleaning and Validation, Common Mistakes Businesses make, Auditor Handling, Advice for young Engineers, and a lot more. This conversation applies broadly to all types of connections in the Life Sciences Industry, and aims to educate and inspire those who want to excel in the manufacturing and engineering space.

Follow ARTO

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

Spotify: Leading Beyond The Lab

Instagram: Instagram (@arto.talent)

TikTok: artotalent on TikTok

Apple Podcasts: Leading Beyond The Lab

Website: Home

Youtube: ARTO Recruitment

Michael Vrijs

Manager Manufacturing Technology

LinkedIn: https://www.linkedin.com/in/michael-vrijs-84b97940/

Thomas McMann

Director - Contracts Division at ARTO

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

Timestamps:

00:00 Career Beginnings

06:09 Cleaning / Validation

13:53 Common Mistakes / Auditor Handling

22:11 Advice for Engineers

#MakingItInManufacturing #ARTOTalent #ManufacturingAndEngineering #ISPE #AI #OPEX #CDMOS #DataIntegrity #Auditing #CSV, CAPEX, Sustainability #Cleaning #Validation

Hosted on Acast. See acast.com/privacy for more information.

• Carsten leads Quality & Compliance within Charles River’s R&D division, where he oversees risk management and the validation of regulated systems.
• With 20 years of experience across in-vitro diagnostics, aseptic manufacturing, and total quality management, he brings deep regulatory and operational expertise.
• He also runs Jasper Consulting and contributes to PTS Training Service, developing AI-powered tools such as VR/AR simulations and digital twins for cleanroom training.
• Previously, he held senior roles in diagnostics and chemical technology and is a regular industry speaker, most recently presenting on AI in cleanroom design at a leading Life Sciences engineering conference.

In this episode, we discuss a range of topics including CSV Validation, Risk Management, Data Integrity, AI, Auditing, Advice for Candidates and more. This conversation applies broadly to all types of connections in the Life Sciences Industry, and aims to educate and inspire those who want to excel in the manufacturing and engineering space.

Follow ARTO

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

Spotify: Leading Beyond The Lab

Instagram: Instagram (@arto.talent)

TikTok: artotalent on TikTok

Apple Podcasts: Leading Beyond The Lab

Website: Home

Youtube: ARTO Recruitment

Carsten Jasper

Senior Director, QRM and CQV (R&D)

LinkedIn: https://www.linkedin.com/in/carsten-jasper-59189982/

Thomas McMann

Director - Contracts Division at ARTO

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

Timestamps:

00:00 Career Beginnings

10:09 CSV Validation & Risk Management

15:13 Data Integrity & AI

23:53 Auditing

31:54 Rounding Up

#MakingItInManufacturing #ARTOTalent #ManufacturingAndEngineering #ISPE #AI #OPEX #CDMOS #DataIntegrity #Auditing #CSV

Hosted on Acast. See acast.com/privacy for more information.

• He is the Founder and Principal at Adams Bio Consulting Ltd, a leadership consultancy dedicated to the Life Sciences industry.
• With 25+ years of experience, he specialises in organisational transformation and leadership development in high-stakes environments.
• His career includes Pharma and Biopharma as well as the broader life sciences remit with previous roles at VP and Group Director levels in Operations, Leadership and Operational Excellence providing services in the UK and extensively across the continent.

In this episode, we discuss a range of topics including aseptic compounding, CDMOs - when, where and why use them, OPEX , leadership, cross functional management and more. This conversation applies broadly to all types of connections in the Life Sciences Industry, and aims to educate and inspire those who want to excel in the manufacturing and engineering space.

Follow ARTO

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

Spotify: Leading Beyond The Lab

Instagram: Instagram (@arto.talent)

TikTok: artotalent on TikTok

Apple Podcasts: Leading Beyond The Lab

Website: Home

Youtube: ARTO Recruitment

Simon Adams

Founder and Principal at Adams Bio Consulting Ltd

LinkedIn: https://www.linkedin.com/in/simon-adams-86005710/

Thomas McMann

Director - Contracts Division at ARTO

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

Timestamps:

00:00 Career Beginnings

07:18 Aseptic Compounding

18:50 CDMOs

28:19 OPEX

45:44 Leadership & Management

#MakingItInManufacturing #ARTOTalent #ManufacturingAndEngineering #ISPE #AI #OPEX #CDMOS

Hosted on Acast. See acast.com/privacy for more information.

• Hazem leads the Global Quality Engineering team at CSL Behring, a global biopharmaceutical company specialising in plasma-derived therapies and he holds a Master's degree in Mechanical Engineering from the University of Utah.
• 30+ years of global experience. Hazem has expertise in manufacturing, process engineering, quality engineering, technology management, and project engineering.
• His career includes significant roles at Fluor Daniel, Jacobs Engineering, Merck, and Johnson & Johnson, where he led global commissioning and qualification initiatives, and is internationally recognised for his contributions to pharmaceutical engineering, including co-authoring the ISPE Baseline Guide 5.
• Hazem has been a featured speaker at the 2025 ISPE Europe Annual Conference, discussing topics such as risk-based qualification and good engineering practices.

In this episode, we discuss a range of topics including risk management, AI, project acceleration and its drawbacks, traits that make a great CQV engineer, common mistakes, cross functional management, as well as tips when it comes to inspectors visiting a new site. This conversation applies broadly to all types of connections in the Life Sciences Industry, and aims to educate and inspire those who want to excel in the manufacturing and engineering space.

Follow ARTO

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

Spotify: Leading Beyond The Lab

Instagram: Instagram (@arto.talent)

TikTok: artotalent on TikTok

Apple Podcasts: Leading Beyond The Lab

Website: Home

Youtube: ARTO Recruitment

Hazem Eleskandarani

Senior Director, Global Quality Engineering

LinkedIn: https://www.linkedin.com/in/hazem-eleskandarani-p-e-pmp-47705842/

Thomas McMann

Director - Contracts Division

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

Timestamps:

00:00 Career Beginnings

12:40 Project Acceleration & Drawbacks

20:36 Risk Management & Project Delays

31:45 AI & Leadership

38:41 Cross Functional Managing

#MakingItInManufacturing #ARTOTalent #ManufacturingAndEngineering #ISPE #AI

Hosted on Acast. See acast.com/privacy for more information.

• Hilary serves as the Chair of the UK GAMP Community of Practice, where she leads initiatives to advance good automated manufacturing practices in the pharmaceutical industry, and was previously the European Quality and Validation Manager at Emerson Automation Solutions.
• 35+ years in process automation engineering and more than 20 years in the life sciences sector, Hilary has extensive experience in computer systems validation and quality assurance, as well as holding a BSc and an MEng in Engineering from Brunel University London.
• Hilary is internationally recognised for her contributions to the ISPE GAMP®5 good practice guides, including co-leading the update of the Process Control Systems Good Practice Guide following the publication of GAMP®5 2nd Edition.
• Hilary was a featured speaker at the 2025 ISPE Europe Annual Conference, where she discussed the integration of digitalised project execution tools in automation and AI-enabled processes.

In this episode, we discuss a range of topics including DeltaV, automation, Gender Diversity within Manufacturing and Engineering, GAMP, the ISPE conference, as well as AI and CyberSecurity and a lot more. This conversation applies broadly to all types of connections in the Life Sciences Industry, and aims to educate and inspire those who want to excel in the manufacturing and engineering space.

Follow ARTO

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

Spotify: Leading Beyond The Lab

Instagram: Instagram (@arto.talent)

TikTok: artotalent on TikTok

Apple Podcasts: Leading Beyond The Lab

Website: Home

Youtube: ARTO Recruitment

Hilary Mills-Baker

European Manager of Quality and Validation

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

Thomas McMann

Director - Contracts Division

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

Timestamps:

00:00 Career Beginnings

12:03 DeltaV & Automation

16:40 AI & Cyber Security

22:31 Gender Diversity in M&E

28:42 GAMP and ISPE

#MakingItInManufacturing #ARTOTalent #ManufacturingAndEngineering #ISPE #AI

Hosted on Acast. See acast.com/privacy for more information.