Making it in Manufacturing

95% of our viewers aren’t subscribed. If you’re watching and not yet subscribed, please subscribe to the channel so you don’t miss future episodes.How do leading CDMOs move beyond scale to become true strategic partners?This week on Making It In Manufacturing, Harry Sloan sat down with John Gagliardi, Sales Director, Key Account Management at Samsung Biologics, with 25+ years of experience spanning operations, supply chain, procurement, sourcing and commercial leadership across biopharma, including previous experience at GSK and leadership in CDMO partnerships. In this episode, John Gagliardi covers:- How Samsung Biologics has evolved as a pure-play CDMO, including US expansion and the value of integrated support from clinical development through commercial supply.- Why long-term partnerships in biomanufacturing depend on value creation beyond capacity, from lifecycle management to flexible supply chain strategies.- What credible ADC capability really looks like, including integrated manufacturing, simplified supply chains and how co-located operations can accelerate speed to market.- The strategic importance of the Lilly Gateway Labs collaboration with Eli Lilly, and how incubating early-stage biotech can strengthen the future innovation ecosystem.- Where growth is heading next for Samsung Biologics, from Bio Campus expansion and emerging modalities to scaling quality while maintaining operational agility.If you are interested in where biomanufacturing partnerships are heading, and how leading CDMOs are thinking beyond capacity alone, this conversation offers practical insight worth your time. Watch the full episode to hear how John approaches growth, innovation and patient impact through a commercial and operational lens.Follow ARTOLinkedIn: https://www.linkedin.com/company/artotalentSpotify: https://open.spotify.com/show/0kEcRZOiJChOoN1KF2n1ngInstagram: https://www.instagram.com/arto.talent?igsh=MWdhbWl5N204a253NQ%3D%3D&utm_source=qrTikTok: https://www.tiktok.com/@artotalent?_t=ZG-8tHbGACAZaj&_r=1Apple Podcasts: https://podcasts.apple.com/us/podcast/leading-beyond-the-lab/id1783115575Website: https://arto-talent.com/Youtube: https://www.youtube.com/@artotalentJohn GagliardiSales Director at Samsung BiologicsLinkedIn: https://www.linkedin.com/in/john-gagliardi-7a8a252/Harry SloanCDMO BD Lead at ARTOLinkedIn: linkedin.com/in/harry-sloan-605620154/?lipi=urn%3Ali%3Apage%3Ad_flagship3_profile_view_base%3B7ieBaX%2FATH6lSPMIPdsI8w%3D%3DTimestamps:00:00 Introduction from New York and conference spotlight00:42 Samsung Biologics as a pure-play CDMO02:10 Building strategic customer partnerships03:45 Differentiation beyond standard CDMO models05:01 Building credibility in ADC manufacturing07:53 Technical collaboration and winning partnerships09:07 Lilly Gateway Labs collaboration11:40 Growth trajectory and future modalities13:19 Scaling while maintaining quality15:00 Patient impact and personal motivation16:35 Closing remarks#MakingItInManufacturing #ARTOTalent #Biomanufacturing #CDMO #Biopharma #SupplyChain #ADC #PharmaceuticalManufacturing #BiotechLeadership Hosted on Acast. See acast.com/privacy for more information.

What does it really take to build credibility as a new CDMO in a highly competitive biologics market, while staying grounded in patient impact?This week on Making It In Manufacturing, Harry Sloan sat down with Joon Chang, Chief Business Officer at Lotte Biologics, with years of experience spanning Pharma, CDMO, project management, and business development roles across global organisations.In this episode, Joon Chang covers:• (02:17) Building credibility as a new CDMO and overcoming the challenge of limited track record while leveraging experienced talent from legacy manufacturing sites• (03:05) Why people and expertise matter more than company age when delivering successful tech transfer, development, and manufacturing outcomes• (04:17) The importance of tailoring partnerships to individual client needs and building long-term relationships across Pharma and biotech organisations• (07:00) Career journey from bench scientist to commercial leadership, and how experience across Pharma and CDMO environments shapes client-centric thinking• (10:10) Creating a patient-centric culture in manufacturing and commercial teams, and why connecting daily operations to patient impact strengthens partnershipsIf you are interested in how emerging CDMOs can differentiate themselves through culture, capability, and client alignment, this episode offers a grounded and practical perspective worth your time.Follow ARTOLinkedIn: https://www.linkedin.com/company/artotalentSpotify: https://open.spotify.com/show/0kEcRZOiJChOoN1KF2n1ngInstagram: https://www.instagram.com/arto.talent?igsh=MWdhbWl5N204a253NQ%3D%3D&utm_source=qrTikTok: https://www.tiktok.com/@artotalent?_t=ZG-8tHbGACAZaj&_r=1Apple Podcasts: https://podcasts.apple.com/us/podcast/leading-beyond-the-lab/id1783115575Website: https://arto-talent.com/Youtube: https://www.youtube.com/@life_sciencesJoon ChangLinkedIn: https://www.linkedin.com/in/joon-chang-a337895/Harry SloanLinkedIn: https://www.linkedin.com/in/harry-sloan-605620154/Timestamps:00:00 Introduction at the DCAT Conference00:33 Overview of Lotte Biologics and market positioning01:20 Capabilities in biologics manufacturing and conjugation02:01 Challenges of entering the CDMO market as a new player03:05 Importance of talent and retained expertise from legacy sites03:52 Building relationships with Pharma and biotech clients04:24 Dual hub model across the US and South Korea05:01 Manufacturing scale advantages and commercial readiness06:19 Speed, cost efficiency, and internal tech transfer benefits07:00 Career journey from Pharma to CDMO leadership08:04 Understanding client mindset from both Pharma and CDMO perspectives08:54 Project management experience and client relationship ownership09:43 Leadership philosophy and full lifecycle thinking10:10 Building an ideal organisational culture10:40 Patient-centric approach and ultra-rare disease considerations11:43 Connecting operations to patient impact12:34 Applying culture to commercial and sales teams13:21 Business development mission and value creation13:40 Leadership approach and empowering teams15:00 Vision for disrupting the CDMO industry16:21 Growth, partnerships, and expanding patient reach17:01 Personal motivation and purpose behind the work18:00 Team culture and collaboration#MakingItInManufacturing #ARTOTalent #Biologics #CDMO #Pharma #Biotech #Manufacturing Hosted on Acast. See acast.com/privacy for more information.

From hands-on pharmacology research to leading strategic projects in advanced manufacturing, this episode explores what it really takes to evolve, adapt, and lead across decades of change in life sciences.This week on Making It In Manufacturing, Harry Sloan sat down with Alison Clayton, Strategic Projects Director at Symbiosis, with over 40 years of experience spanning pharmacology research, pre-clinical and clinical development, and pharmaceutical manufacturing.In this episode, Alison Clayton covers:(00:00) Transitioning from academia into industry and navigating major company acquisitions early in a career(01:40) Moving beyond the lab into strategic, customer-facing roles and discovering a passion for leadership(03:35) Adapting to constant organisational change while maintaining a patient-first mindset(07:26) The risks of scaling too quickly in CDMOs and the importance of realistic capacity and strong partnerships(10:02) Maintaining quality and regulatory standards while growing in a highly competitive pharmaceutical landscapeThis conversation offers a grounded perspective on long-term career development, leadership in complex environments, and the evolving demands of pharmaceutical manufacturing. If you are building a career in life sciences or scaling within a CDMO environment, this episode provides practical insights worth applying.Follow ARTOLinkedIn: https://www.linkedin.com/company/artotalentSpotify: https://open.spotify.com/show/0kEcRZOiJChOoN1KF2n1ngInstagram: https://www.instagram.com/arto.talent?igsh=MWdhbWl5N204a253NQ%3D%3D&utm_source=qrTikTok: https://www.tiktok.com/@artotalent?_t=ZG-8tHbGACAZaj&_r=1Apple Podcasts: https://podcasts.apple.com/us/podcast/leading-beyond-the-lab/id1783115575Website: https://arto-talent.com/Youtube: https://www.youtube.com/@life_sciencesAlison ClaytonLinkedIn: https://www.linkedin.com/in/alison-clayton-78816711/Harry SloanLinkedIn: https://www.linkedin.com/in/harry-sloan-605620154/Timestamps:00:00 Introduction to the episode00:14 Alison Clayton introduction and career reflection00:53 Transition from academia to industry01:15 Experience at Syntex Pharmaceuticals, Roche, and Quintiles01:40 Moving into strategic and customer-facing roles02:24 Leadership style shaped by scientific background02:50 End-to-end experience across drug development03:13 Navigating challenges and career-defining moments03:35 Adapting through multiple company transitions04:24 Balancing commercial goals with patient outcomes04:56 Experiences in a male-dominated industry05:51 Advice for women in life sciences leadership06:09 Career development without a fixed plan07:00 Balancing career and family life07:26 Scaling challenges in CDMOs08:30 Risks of overpromising and underdelivering09:28 Importance of supply chain and transparency10:02 Maintaining quality and regulatory compliance10:27 Overview of Symbiosis10:57 Market demand for sterile manufacturing11:20 Scottish identity and company culture11:39 Differentiation in the CDMO market12:31 Importance of flexibility and partnerships13:21 Building long-term client relationships13:41 Future outlook for Symbiosis14:05 Evolution of biologics and impact on patients14:32 Career reflection and delivering medicines to patients15:17 What excites Alison about the future#MakingItInManufacturing #ARTOTalent #PharmaceuticalManufacturing #LifeSciences #CDMO #Biologics #DrugDevelopment Hosted on Acast. See acast.com/privacy for more information.

95% of our viewers aren’t subscribed. If you’re watching and not yet subscribed, please subscribe to the channel so you don’t miss future episodes.The CDMO model is evolving fast, but what actually separates the leaders from the rest in today’s market?This week on Making It In Manufacturing, Harry Sloan sat down with Thierry Van Nieuwenhove, CEO of Quotient Sciences, with 25+ years of experience spanning business development, engineering, global manufacturing leadership, and executive roles.In this episode, Thierry covers:• The evolution of the CDMO landscape over 25 years, from API-focused events to a global, multi-disciplinary pharma ecosystem• How Quotient Sciences built a unique translational pharmaceutics platform to combine clinical studies with drug manufacturing, accelerating development timelines by up to 12 months • A career journey from chemical engineering into global business development and leadership, including building manufacturing capabilities in India and working across Europe and the US • Why speed, efficiency, and proof of concept are critical in today’s funding-constrained biotech environment • The growing impact of AI, global innovation shifts including China, and how CDMOs must adapt to remain competitive and support emerging biotech pipelines If you are looking to understand where the CDMO space is heading, and what it takes to lead in a rapidly evolving pharmaceutical market, this episode offers a clear and practical perspective. Be sure to watch the full conversation.Follow ARTOLinkedIn: https://www.linkedin.com/company/artotalentSpotify: https://open.spotify.com/show/0kEcRZOiJChOoN1KF2n1ngInstagram: https://www.instagram.com/arto.talent?igsh=MWdhbWl5N204a253NQ%3D%3D&utm_source=qrTikTok: https://www.tiktok.com/@artotalent?_t=ZG-8tHbGACAZaj&_r=1Apple Podcasts: https://podcasts.apple.com/us/podcast/leading-beyond-the-lab/id1783115575Website: https://arto-talent.com/Youtube: https://www.youtube.com/@life_sciencesThierry Van NieuwenhoveCEO at Quotient SciencesLinkedIn: https://www.linkedin.com/in/thierryvan/Harry SloanBD CDMO LeadLinkedIn: https://www.linkedin.com/in/harry-sloan-605620154/Timestamps:00:00 Introduction to Making It In Manufacturing at DCAT00:20 Meet Thierry Van Nieuwenhove, CEO of Quotient Sciences01:40 Overview of Quotient Sciences and translational pharmaceutics03:10 Competitive advantage in the CDMO market04:23 Career journey from engineering to CEO07:00 Leadership development across global roles08:18 Operating across international markets and cultures09:17 Translating early-stage assets into clinical success12:00 Industry challenges including funding constraints14:25 AI, partnerships, and innovation in formulation16:01 Data science and accelerating development timelines17:32 Global trends including China’s role in innovation19:56 Strategic adaptation to industry shifts21:34 Demand for integrated CDMO models22:55 Customer expectations: speed, excellence, and innovation25:28 The importance of trust and long-term partnerships#MakingItInManufacturing #ARTOTalent #CDMO #PharmaceuticalManufacturing #Biotech #DrugDevelopment #LifeSciences Hosted on Acast. See acast.com/privacy for more information.

95% of our viewers aren’t subscribed. If you’re watching and not yet subscribed, please subscribe to the channel so you don’t miss future episodes.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 efficiencyIf 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 ARTOLinkedIn: https://www.linkedin.com/company/artotalentSpotify: https://open.spotify.com/show/0kEcRZOiJChOoN1KF2n1ngInstagram: https://www.instagram.com/arto.talent?igsh=MWdhbWl5N204a253NQ%3D%3D&utm_source=qrTikTok: https://www.tiktok.com/@artotalent?_t=ZG-8tHbGACAZaj&_r=1Apple Podcasts: https://podcasts.apple.com/us/podcast/leading-beyond-the-lab/id1783115575Website: https://arto-talent.com/Youtube: https://www.youtube.com/@artotalentDr Adriana Kiedzierska-MencfeldLinkedIn: https://www.linkedin.com/in/dr-adriana-kiedzierska-mencfeld/Harry SloanLinkedIn: https://www.linkedin.com/in/harry-sloan-605620154/Timestamps:00:00 Introduction00:33 Moving beyond science into leadership02:06 Career-defining moments and leadership growth04:56 Leading through COVID and regulatory pressure06:01 FDA inspection and managing high-stakes environments07:13 Transition to CDMO and company transformation09:20 Launch of Resins Bio and stepping into CEO role11:39 Building trust and delivering for clients12:29 Cost competitiveness and market positioning14:20 Speed, quality, and CDMO differentiation15:22 Market trends and opportunities in biologics17:33 CDMO positioning and capabilities18:09 Balancing existing clients and new business20:08 Personal career journey and challenges21:44 Advice for women in biotech leadership22:46 Future of biologics manufacturing24:33 Motivation and leadership purpose#MakingItInManufacturing #ARTOTalent #Biotech #CDMO #Biologics #LifeSciences #ManufacturingLeadership Hosted on Acast. See acast.com/privacy for more information.

95% of our viewers aren’t subscribed. If you’re watching and not yet subscribed, please subscribe to the channel so you don’t miss future episodes.What does it take to scale pharmaceutical packaging operations globally while maintaining flexibility, quality, and speed to market? In this episode, we explore how strategic packaging partnerships directly impact patient access and commercial success.This week on Making It In Manufacturing, Harry Sloan sat down with Peter Belden, CCO of Tjoapack, with over 25 years of experience spanning outsourced pharmaceutical services across small, mid-sized, and large organisations, primarily within packaging and global supply chain operations.In this episode, Peter Belden covers:00:00 How pharmaceutical packaging plays a critical role beyond the final step, directly influencing timelines and global market access01:25 The growing need for late-stage customisation and flexible packaging to meet changing patient demand across multiple markets02:21 Why successful CDMO partnerships start with deep client understanding, including patient population, dosing, and supply chain needs03:43 Balancing speed to market with quality through strong planning, collaboration, and supply chain alignment04:43 Strategic expansion in the US, including facility growth and new packaging lines to support long-term demandThis conversation offers a practical look at how packaging strategy, operational discipline, and global experience come together to support pharmaceutical innovation at scale. If you are involved in manufacturing, supply chain, or CDMO partnerships, this episode provides valuable perspective grounded in real industry execution.Follow ARTOLinkedIn: https://www.linkedin.com/company/artotalentSpotify: https://open.spotify.com/show/0kEcRZOiJChOoN1KF2n1ngInstagram: https://www.instagram.com/arto.talent?igsh=MWdhbWl5N204a253NQ%3D%3D&utm_source=qrTikTok: https://www.tiktok.com/@artotalent?_t=ZG-8tHbGACAZaj&_r=1Apple Podcasts: https://podcasts.apple.com/us/podcast/leading-beyond-the-lab/id1783115575Website: https://arto-talent.com/Youtube: https://www.youtube.com/@artotalentPeter BeldenLinkedIn: https://www.linkedin.com/in/petersbelden/Harry SloanLinkedIn: https://www.linkedin.com/in/harry-sloan-605620154/Timestamps:00:00 Introduction00:15 Overview of the company and CDMO positioning01:04 Evolution of pharmaceutical packaging and flexibility01:48 Late-stage customisation and supply chain adaptability02:21 Building strong client partnerships in packaging02:56 Scoping projects and delivering tailored solutions03:21 Industry change and demand for speed to market03:43 Balancing quality with responsiveness04:20 Supply chain collaboration and planning cadence04:34 US expansion and growth strategy05:06 Facility expansion and new packaging lines05:31 Managing growth and operational challenges06:07 Long-term vision and scaling capabilities06:50 Career journey into leadership07:31 International experience and UK market integration08:39 Adapting to global markets and client needs09:03 Delivering across 40+ countries10:05 Motivation and impact on patient access10:22 Closing remarks#MakingItInManufacturing #ARTOTalent #PharmaManufacturing #CDMO #SupplyChain #Biopharma Hosted on Acast. See acast.com/privacy for more information.

95% of our viewers aren’t subscribed. If you’re watching and not yet subscribed, please subscribe to the channel so you don’t miss future episodes.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 expectationsIf 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 ARTOLinkedIn: https://www.linkedin.com/company/artotalentSpotify: https://open.spotify.com/show/0kEcRZOiJChOoN1KF2n1ngInstagram: https://www.instagram.com/arto.talent?igsh=MWdhbWl5N204a253NQ%3D%3D&utm_source=qrTikTok: https://www.tiktok.com/@artotalent?_t=ZG-8tHbGACAZaj&_r=1Apple Podcasts: https://podcasts.apple.com/us/podcast/leading-beyond-the-lab/id1783115575Website: https://arto-talent.com/Youtube: https://www.youtube.com/@artotalentDavid StevensLinkedIn: https://www.linkedin.com/in/davecstevens/Harry SloanLinkedIn: https://www.linkedin.com/in/harry-sloan-605620154/Timestamps:00:00 Introduction00:14 Guest introduction and CEO journey01:02 Career background and move into @Kindeva02:50 Building and scaling a biologics CDMO05:41 Vision for inhalation technology and sustainability07:44 Future of sterile manufacturing and facility design09:57 Trust and partnerships in CDMO relationships12:12 Managing growth, capacity, and reputation12:36 Long-term vision and defining success as CEO#MakingItInManufacturing #ARTOTalent #PharmaceuticalManufacturing #CDMO #Biologics #LifeSciences #ManufacturingLeadership Hosted on Acast. See acast.com/privacy for more information.

95% of our viewers aren’t subscribed. If you’re watching and not yet subscribed, please subscribe to the channel so you don’t miss future episodes.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 efficiencyIf 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 ARTOLinkedIn: https://www.linkedin.com/company/artotalentSpotify: https://open.spotify.com/show/0kEcRZOiJChOoN1KF2n1ngInstagram: https://www.instagram.com/arto.talent?igsh=MWdhbWl5N204a253NQ%3D%3D&utm_source=qrTikTok: https://www.tiktok.com/@artotalent?_t=ZG-8tHbGACAZaj&_r=1Apple Podcasts: https://podcasts.apple.com/us/podcast/leading-beyond-the-lab/id1783115575Website: https://arto-talent.com/Youtube: https://www.youtube.com/@artotalentDr Adriana Kiedzierska-MencfeldLinkedIn: https://www.linkedin.com/in/dr-adriana-kiedzierska-mencfeld/Harry SloanLinkedIn: https://www.linkedin.com/in/harry-sloan-605620154/Timestamps:00:00 Introduction00:33 Moving beyond science into leadership02:06 Career-defining moments and leadership growth04:56 Leading through COVID and regulatory pressure06:01 FDA inspection and managing high-stakes environments07:13 Transition to CDMO and company transformation09:20 Launch of Resins Bio and stepping into CEO role11:39 Building trust and delivering for clients12:29 Cost competitiveness and market positioning14:20 Speed, quality, and CDMO differentiation15:22 Market trends and opportunities in biologics17:33 CDMO positioning and capabilities18:09 Balancing existing clients and new business20:08 Personal career journey and challenges21:44 Advice for women in biotech leadership22:46 Future of biologics manufacturing24:33 Motivation and leadership purpose#MakingItInManufacturing #ARTOTalent #Biotech #CDMO #Biologics #LifeSciences #ManufacturingLeadership Hosted on Acast. See acast.com/privacy for more information.

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 facilitiesIf 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 ARTOLinkedIn: https://www.linkedin.com/company/artotalentSpotify: https://open.spotify.com/show/0kEcRZOiJChOoN1KF2n1ngInstagram: https://www.instagram.com/arto.talent?igsh=MWdhbWl5N204a253NQ%3D%3D&utm_source=qrTikTok: https://www.tiktok.com/@artotalent?_t=ZG-8tHbGACAZaj&_r=1Apple Podcasts: https://podcasts.apple.com/us/podcast/leading-beyond-the-lab/id1783115575Website: https://arto-talent.com/Youtube: https://www.youtube.com/@life_sciencesSarah StevensLinkedIn: https://www.linkedin.com/in/sarah-stevens-1135964Harry SloanLinkedIn: https://www.linkedin.com/in/harry-sloan-605620154/#MakingItInManufacturing #ARTOTalent #Biopharma #CDMO #GMP #BiotechManufacturing #LifeSciences Hosted on Acast. See acast.com/privacy for more information.

95% of our viewers aren't following, please check!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 themWhether 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 ARTOLinkedIn: https://www.linkedin.com/company/artotalent/?viewAsMember=trueSpotify: 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.comYoutube: https://www.youtube.com/@artotalentDaniel ShearerHead of Automation at FUJIFILM Biotechnologies LinkedIn: https://www.linkedin.com/in/daniel-shearer-80574b36/Thomas McMannDirector - Contracts DivisionLinkedIn: https://www.linkedin.com/in/thomas-mcmann-05540a10b/Timestamps:00:24 $400M Multi-Modal Asset01:38 Automation Challenges06:59 Standardisation11:18 Integration + Common Pitfalls Hosted on Acast. See acast.com/privacy for more information.

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 ARTOLinkedIn: / 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 ClavelLinkedIn: / philippe-clavel-cdmo-gxapis Harry Sloan / harry-sloan-605620154 Timestamps00:00 Introduction00:17 Overview of CuraPath and its drug delivery focus02:29 What differentiates CuraPath as a CDMO04:00 Balancing cost, scalability and complex modalities05:14 Growth from discovery projects to commercial manufacturing06:10 Expanding expertise from polymers to lipid nanoparticle technologies07:41 Supporting customers across the full development journey09:21 The significance of delivering a therapy reaching the market10:12 Transitioning to GMP manufacturing and operational discipline11:34 Challenges that come with scaling CDMO operations13:27 Building a culture that embraces problems and deviations15:27 Understanding customer motivations and building trust18:24 Collaboration across supply chains within drug manufacturing21:17 Maintaining company culture while scaling leadership23:32 Encouraging challenge and empowerment within teams27:13 Advice for business development professionals in CDMO31:08 Future outlook for CuraPath and its pipeline34:25 Personal motivation behind leading the company39:02 Episode closing#MakingItInManufacturing #ARTOTalent #CDMO #PharmaceuticalManufacturing #DrugDelivery #Biotech #LifeSciences Hosted on Acast. See acast.com/privacy for more information.

95% of our listeners aren't following, please check!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 integrityIf 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 ARTOLinkedIn: https://www.linkedin.com/company/artotalent/?viewAsMember=trueSpotify: 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.comYoutube: https://www.youtube.com/@artotalentThana SubramanianGAMP Global Steering Committee Co-ChairLinkedIn: https://www.linkedin.com/in/thanasubramanian/Thomas McMannDirector - Contracts DivisionLinkedIn: https://www.linkedin.com/in/thomas-mcmann-05540a10b/Timestamps:00:27 ISPE History02:33 GAMP New Good Practice Guide (GxP Process Control Systems) Third Edition07:32 Benefits of ISPE and GAMP Hosted on Acast. See acast.com/privacy for more information.

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/artotalentSpotify: https://open.spotify.com/show/0kEcRZOiJChOoN1KF2n1ngInstagram: https://www.instagram.com/arto.talent?igsh=MWdhbWl5N204a253NQ%3D%3D&utm_source=qrTikTok: https://www.tiktok.com/@artotalent?_t=ZG-8tHbGACAZaj&_r=1Apple Podcasts: https://podcasts.apple.com/us/podcast/leading-beyond-the-lab/id1783115575Website: https://arto-talent.com/YouTube: https://www.youtube.com/@life_sciencesMichael KocherCEO at Xellia PharmaceuticalsLinkedIn: https://www.linkedin.com/in/michael-kocher-191863a/Thomas McMannDirector - Contracts DivisionLinkedIn: https://www.linkedin.com/in/thomas-mcmann-05540a10b/ Hosted on Acast. See acast.com/privacy for more information.

97% of our viewers don't realise they aren't subscribed, please double check, thank you!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 supplyHis unconventional journey from the military into life sciences leadership, and what it taught him about resilience and decision-makingReal-world examples of project success and failure, including moments where patient access was directly at riskWhat it’s like operating as a global pharmaceutical executive, managing multi-site, multi-culture manufacturing networksInside Novo Nordisk’s US expansion, including the launch of its first US-produced drug and early GLP-1 manufacturing challengesIf 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 ARTOLinkedIn:   / 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.comYoutube:    / @life_sciences  Preben HaaningBoard Member at Xellia PharmaceuticalsLinkedIn:   / preben-haaning-18a6193  Thomas McMannDirector - Contracts DivisionLinkedIn:   / thomas-mcmann-05540a10b  Timestamps:02:03 Xellia Pharmaceuticals11:07 From the Military to Life Sciences19:11 Project Success and Failure28:51 Global Pharmaceutical Executive46:41 Novo Nordisk Expansion of US Supply Hosted on Acast. See acast.com/privacy for more information.

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 ARTOLinkedIn: https://www.linkedin.com/company/artotalentSpotify: https://open.spotify.com/show/0kEcRZOiJChOoN1KF2n1ngInstagram: https://www.instagram.com/arto.talent?igsh=MWdhbWl5N204a253NQ%3D%3D&utm_source=qrTikTok: https://www.tiktok.com/@artotalent?_t=ZG-8tHbGACAZaj&_r=1Apple Podcasts: https://podcasts.apple.com/us/podcast/leading-beyond-the-lab/id1783115575Website: https://arto-talent.com/Youtube: https://www.youtube.com/@life_sciencesGregor Kawaletz - CEO at MabionLinkedIn: https://www.linkedin.com/in/gregor-kawaletz-276a4830/Thomas McMann - Director At ARTOLinkedIn: https://www.linkedin.com/in/thomas-mcmann-05540a10b/Timestamps:00:00 First month as CEO at Mabion02:19 Two decades in the CDMO space including NextPharma, Catalent and Recipharm02:42 Moving from CCO to CEO05:10 Growth strategy and business model evolution06:57 €500k innovation award and WPD09:41 Biosimilars regulation and market access11:04 Navigating a multipolar global supply landscape12:47 Expanding Mabion’s future offering#MakingItInManufacturing #ARTOTalent #CDMO #Biologics #Biosimilars #LifeSciences #ManufacturingLeadership Hosted on Acast. See acast.com/privacy for more information.

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 ARTOLinkedIn: https://www.linkedin.com/company/artotalentSpotify: https://open.spotify.com/show/0kEcRZOiJChOoN1KF2n1ngInstagram: https://www.instagram.com/arto.talent?igsh=MWdhbWl5N204a253NQ%3D%3D&utm_source=qrTikTok: https://www.tiktok.com/@artotalent?_t=ZG-8tHbGACAZaj&_r=1Apple Podcasts: https://podcasts.apple.com/us/podcast/leading-beyond-the-lab/id1783115575Website: https://arto-talent.com/YouTube: https://www.youtube.com/@life_sciencesAlexander SchäferLinkedIn: https://www.linkedin.com/in/alexander-sch%C3%A4fer-4515a433/Tom McMannLinkedIn: https://www.linkedin.com/in/thomas-mcmann-05540a10b/Timestamps:00:00 Introduction and context from CPHI00:54 Overview of European operations and contract packaging services01:28 Servicing biotech versus pharma clients03:12 Building trust through execution and reputation04:24 Managing challenges with open communication and solutions06:29 Essential skills for business development professionals07:21 Investment in injectables, devices, and future capacity10:25 Closing reflections#MakingItInManufacturing #ARTOTalent #PharmaManufacturing #Biotech #BusinessDevelopment #CPHI #ContractPackaging Hosted on Acast. See acast.com/privacy for more information.

The CDMO Changing the Game in Drug DeliveryThis 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 ARTOLinkedIn: 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.comYoutube: https://www.youtube.com/@life_sciencesAnkit GuptaCEO at InstapillLinkedIn: https://www.linkedin.com/in/reachankit/Thomas McMannDirector - Contracts DivisionLinkedIn: https://www.linkedin.com/in/thomas-mcmann-05540a10b/Timestamps:00:11 Stand Out FDA Approval & Speed to Market08:00 Global Growth and Operations10:55 Insights & Leadership Takeaways Hosted on Acast. See acast.com/privacy for more information.

Continuous manufacturing is reshaping biologics - and today’s guest is one of the leaders driving that shift.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 ARTOLinkedIn: https://www.linkedin.com/company/artotalentSpotify: https://open.spotify.com/show/0kEcRZOiJChOoN1KF2n1ngInstagram: https://www.instagram.com/arto.talent?igsh=MWdhbWl5N204a253NQ%3D%3D&utm_source=qrTikTok: https://www.tiktok.com/@artotalent?_t=ZG-8tHbGACAZaj&_r=1Apple Podcasts: https://podcasts.apple.com/us/podcast/leading-beyond-the-lab/id1783115575Website: https://arto-talent.comYoutube: https://www.youtube.com/@life_sciencesHimanshu GadgilCEO of EnzeneLinkedIn: https://www.linkedin.com/in/himanshu-gadgil-3326307/Thomas McMannDirector - Contracts DivisionLinkedIn: https://www.linkedin.com/in/thomas-mcmann-05540a10b/Timestamps:00:10 Enzene's Vision04:10 Building & Scaling a Global Platform07:51 Enzene's Competitive Edge14:56 The Future of CDMO's21:01 Vision for Enzene's Future Growth Hosted on Acast. See acast.com/privacy for more information.

The CDMO everyone’s suddenly talking about, and the CEO taking it to the next level.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 ARTOLinkedIn: https://www.linkedin.com/company/artotalentSpotify: https://open.spotify.com/show/0kEcRZOiJChOoN1KF2n1ngInstagram: https://www.instagram.com/arto.talent?igsh=MWdhbWl5N204a253NQ%3D%3D&utm_source=qrTikTok: https://www.tiktok.com/@artotalent?_t=ZG-8tHbGACAZaj&_r=1Apple Podcasts: https://podcasts.apple.com/us/podcast/leading-beyond-the-lab/id1783115575Website: https://arto-talent.comYoutube: https://www.youtube.com/@life_sciencesDirk T. LangeCEO at Pyramid Pharma ServicesLinkedIn: https://www.linkedin.com/in/langedirk/Thomas McMannDirector - Contracts DivisionLinkedIn: https://www.linkedin.com/in/thomas-mcmann-05540a10b/Timestamps:00:11 Pyramid Overview01:41 Key Data03:46 Doubling Fill Finish Capabilities05:38 Growth Challenges Hosted on Acast. See acast.com/privacy for more information.

In this episode of the Making It in Manufacturing Spotlight Series, we sit down with Raj Puri, Chief Commercial Officer at Argonaut Manufacturing Services. 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 ARTOLinkedIn: https://www.linkedin.com/company/artotalentSpotify: https://open.spotify.com/show/0kEcRZOiJChOoN1KF2n1ngInstagram: https://www.instagram.com/arto.talent?igsh=MWdhbWl5N204a253NQ%3D%3D&utm_source=qrTikTok: https://www.tiktok.com/@artotalent?_t=ZG-8tHbGACAZaj&_r=1Apple Podcasts: https://podcasts.apple.com/us/podcast/leading-beyond-the-lab/id1783115575Website: https://arto-talent.comYoutube: https://www.youtube.com/@life_sciencesRaj PuriCCO at Argonaut Manufacturing ServicesLinkedIn: https://www.linkedin.com/in/raj-puri-3137665/Thomas McMannDirector - Contracts Division at ARTOLinkedIn: https://www.linkedin.com/in/thomas-mcmann-05540a10b/Timestamps:00:10 Stepping Into The Role & Early Lessons04:03 Scaling Smart: Challenges and Capabilities09:07 Culture, Talent & The Future Hosted on Acast. See acast.com/privacy for more information.

The CDMO Changing the Game in Drug DeliveryThis 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 ARTOLinkedIn: https://www.linkedin.com/company/artotalentSpotify: https://open.spotify.com/show/0kEcRZOiJChOoN1KF2n1ngInstagram: https://www.instagram.com/arto.talent?igsh=MWdhbWl5N204a253NQ%3D%3D&utm_source=qrTikTok: https://www.tiktok.com/@artotalent?_t=ZG-8tHbGACAZaj&_r=1Apple Podcasts: https://podcasts.apple.com/us/podcast/leading-beyond-the-lab/id1783115575Website: https://arto-talent.comYoutube: https://www.youtube.com/@life_sciencesAnkit GuptaCEO at InstapillLinkedIn: https://www.linkedin.com/in/reachankit/Thomas McMannDirector - Contracts DivisionLinkedIn: https://www.linkedin.com/in/thomas-mcmann-05540a10b/Timestamps:00:11 Stand Out FDA Approval & Speed to Market08:00 Global Growth and Operations10:55 Insights & Leadership Takeaways Hosted on Acast. See acast.com/privacy for more information.

What does it really take to build one of Europe’s fastest-growing drug-product CDMOs, and do it with scientific precision, culture-first leadership, and a B-Corp mindset?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 ARTOLinkedIn: https://www.linkedin.com/company/artotalentSpotify: https://open.spotify.com/show/0kEcRZOiJChOoN1KF2n1ngInstagram: https://www.instagram.com/arto.talent?igsh=MWdhbWl5N204a253NQ%3D%3D&utm_source=qrTikTok: https://www.tiktok.com/@artotalent?_t=ZG-8tHbGACAZaj&_r=1Apple Podcasts: https://podcasts.apple.com/us/podcast/leading-beyond-the-lab/id1783115575Website: https://arto-talent.comYoutube: https://www.youtube.com/@life_sciencesHanns-Christian MahlerCEO at ten23LinkedIn: https://www.linkedin.com/in/hanns-christian-mahler/Thomas McMannDirector - Contracts Division at ARTOLinkedIn: https://www.linkedin.com/in/thomas-mcmann-05540a10b/Timestamps:00:00 Career Beginnings & ten2308:18 Challenges with Scaling14:29 Culture & Leadership Style20:00 Scientific Rigour vs Sustainability26:07 Challenges with Geopolitical Issues29:13 The Future & AI Hosted on Acast. See acast.com/privacy for more information.

If you're leading in pharma, biotech, or manufacturing, this is essential listening.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 directionIf you're in a leadership role within pharma or biotech, this is the episode you’ll want your entire team to hear.Follow ARTOLinkedIn: https://www.linkedin.com/company/artotalentSpotify: https://open.spotify.com/show/0kEcRZOiJChOoN1KF2n1ngInstagram: https://www.instagram.com/arto.talent?igsh=MWdhbWl5N204a253NQ%3D%3D&utm_source=qrTikTok: https://www.tiktok.com/@artotalent?_t=ZG-8tHbGACAZaj&_r=1Apple Podcasts: https://podcasts.apple.com/us/podcast/leading-beyond-the-lab/id1783115575Website: https://arto-talent.comYoutube: https://www.youtube.com/@life_sciencesJ.D. MoweryDivision President - CDMOLinkedIn: https://www.linkedin.com/in/jdmowery/Thomas McMannDirector - Contracts Division at ARTOLinkedIn: https://www.linkedin.com/in/thomas-mcmann-05540a10b/Timestamps:00:00 Filling Sites & Scaling Smartly06:38 Quality as a Differentiator13:30 Partnering with Purpose17:19 The Future of CDMOs and AI Hosted on Acast. See acast.com/privacy for more information.

In this episode, we’re joined by Abbas Hussain, an internationally recognised engineering leader and current Projects & Engineering Manager at EUROAPI.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 ARTOLinkedIn: https://www.linkedin.com/company/artotalentSpotify: Leading Beyond The LabInstagram: Instagram (@arto.talent)TikTok: artotalent on TikTokApple Podcasts: Leading Beyond The LabWebsite: HomeYoutube: ARTO Recruitment\Abbas HussainProjects & Engineering Manager at EUROAPI.LinkedIn: https://www.linkedin.com/in/abbas-sayyed-028a7812/Thomas McMannDirector - Contracts Division at ARTOLinkedIn: https://www.linkedin.com/in/thomas-mcmann-05540a10b/Timestamps:00:00 Career Beginnings08:31 Culture Differences16:58 CAPEX, Project Planning & Delays30:42 Sustainability36:54 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.

In this episode, we feature Michael Vrijs, a well-recognised expert in cleaning validation and biopharma manufacturing, known for turning complex compliance into practical strategy: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 ARTOLinkedIn: https://www.linkedin.com/company/artotalentSpotify: Leading Beyond The LabInstagram: Instagram (@arto.talent)TikTok: artotalent on TikTokApple Podcasts: Leading Beyond The LabWebsite: HomeYoutube: ARTO RecruitmentMichael VrijsManager Manufacturing TechnologyLinkedIn: https://www.linkedin.com/in/michael-vrijs-84b97940/Thomas McMannDirector - Contracts Division at ARTOLinkedIn: https://www.linkedin.com/in/thomas-mcmann-05540a10b/Timestamps:00:00 Career Beginnings06:09 Cleaning / Validation13:53 Common Mistakes / Auditor Handling22:11 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.

In this episode, we are joined by Carsten Jasper, a globally recognised leader specialising in pharmaceutical quality, regulatory compliance, and digital transformation within life sciences.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 ARTOLinkedIn: https://www.linkedin.com/company/artotalentSpotify: Leading Beyond The LabInstagram: Instagram (@arto.talent)TikTok: artotalent on TikTokApple Podcasts: Leading Beyond The LabWebsite: HomeYoutube: ARTO RecruitmentCarsten JasperSenior Director, QRM and CQV (R&D)LinkedIn: https://www.linkedin.com/in/carsten-jasper-59189982/Thomas McMannDirector - Contracts Division at ARTOLinkedIn: https://www.linkedin.com/in/thomas-mcmann-05540a10b/Timestamps:00:00 Career Beginnings10:09 CSV Validation & Risk Management 15:13 Data Integrity & AI23:53 Auditing31:54 Rounding Up#MakingItInManufacturing #ARTOTalent #ManufacturingAndEngineering #ISPE #AI #OPEX #CDMOS #DataIntegrity #Auditing #CSV Hosted on Acast. See acast.com/privacy for more information.

In this episode of Making It In Manufacturing, we speak with Simon Adams, a seasoned advisor and founder of Adams Bio Consulting Ltd, about the evolving demands of leadership in the Life Sciences sector.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 ARTOLinkedIn: https://www.linkedin.com/company/artotalentSpotify: Leading Beyond The LabInstagram: Instagram (@arto.talent)TikTok: artotalent on TikTokApple Podcasts: Leading Beyond The LabWebsite: HomeYoutube: ARTO RecruitmentSimon AdamsFounder and Principal at Adams Bio Consulting LtdLinkedIn: https://www.linkedin.com/in/simon-adams-86005710/Thomas McMannDirector - Contracts Division at ARTOLinkedIn: https://www.linkedin.com/in/thomas-mcmann-05540a10b/Timestamps:00:00 Career Beginnings07:18 Aseptic Compounding18:50 CDMOs28:19 OPEX45:44 Leadership & Management#MakingItInManufacturing #ARTOTalent #ManufacturingAndEngineering #ISPE #AI #OPEX #CDMOS Hosted on Acast. See acast.com/privacy for more information.

In this episode, we feature Hazem Eleskandarani, P.E., PMP, a distinguished leader in pharmaceutical engineering and quality assurance: 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 ARTOLinkedIn: https://www.linkedin.com/company/artotalentSpotify: Leading Beyond The LabInstagram: Instagram (@arto.talent)TikTok: artotalent on TikTokApple Podcasts: Leading Beyond The LabWebsite: HomeYoutube: ARTO RecruitmentHazem Eleskandarani Senior Director, Global Quality EngineeringLinkedIn: https://www.linkedin.com/in/hazem-eleskandarani-p-e-pmp-47705842/Thomas McMannDirector - Contracts DivisionLinkedIn: https://www.linkedin.com/in/thomas-mcmann-05540a10b/Timestamps:00:00 Career Beginnings12:40 Project Acceleration & Drawbacks20:36 Risk Management & Project Delays31:45 AI & Leadership38:41 Cross Functional Managing #MakingItInManufacturing #ARTOTalent #ManufacturingAndEngineering #ISPE #AI Hosted on Acast. See acast.com/privacy for more information.

In this episode, we feature Hilary Mills-Baker, a distinguished expert in process automation and computer systems validation within the life sciences sector: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 ARTOLinkedIn: https://www.linkedin.com/company/artotalentSpotify: Leading Beyond The LabInstagram: Instagram (@arto.talent)TikTok: artotalent on TikTokApple Podcasts: Leading Beyond The LabWebsite: HomeYoutube: ARTO RecruitmentHilary Mills-BakerEuropean Manager of Quality and ValidationLinkedIn: https://www.linkedin.com/in/hilarymillsbaker/Thomas McMannDirector - Contracts DivisionLinkedIn: https://www.linkedin.com/in/thomas-mcmann-05540a10b/Timestamps:00:00 Career Beginnings12:03 DeltaV & Automation16:40 AI & Cyber Security22:31 Gender Diversity in M&E28:42 GAMP and ISPE#MakingItInManufacturing #ARTOTalent #ManufacturingAndEngineering #ISPE #AI Hosted on Acast. See acast.com/privacy for more information.