🚀 The first-ever returning guest on the podcast! In this episode, Hemish sat down with Brian Nunnally, Enterprise Quality Control Head at CSL, to dive deep into one of the most important topics in career growth - mentorship. Brian’s career is a perfect example of how mentorship, strategic career moves, and leadership development can accelerate your path to the top. He shares his journey from QC scientist to leading an entire global Quality Control organization, and why having the right mentors ...
Mar 05, 2025•51 min•Season 2Ep. 21
🎙️Would you move to a new country with no network, no guarantees - just a dream and two suitcases? That’s exactly what Katarina Bartle did. She left Slovakia, where she had built a strong academic foundation, moved to Germany for her PhD, and then took a huge risk, relocating to the U.S. for what was meant to be a short postdoc. 27 years later, she’s still here - now a biotech quality leader who has shaped global teams and helped redefine how companies approach quality. In today’s episode of Le...
Feb 19, 2025•36 min•Season 2Ep. 20
In today’s episode, I was joined by Biana Torres , Senior Director of Quality Assurance at Encoded Therapeutics . I really wanted to speak to Biana because she has built a strong leadership career in quality, moving through both big pharma and small biotech. She’s now leading in the dynamic world of cell and gene therapy, where quality and adaptability are critical. Biana started out aiming to be a doctor, pivoted into biotech by accident, and has since built a career leading quality teams throu...
Feb 12, 2025•33 min•Season 2Ep. 19
In today’s episode, I was joined by Shane Ernst, Vice President of Quality at Empower Pharmacy. I really wanted to speak to Shane because he has built an incredible career in quality leadership despite being an introvert - a trait many in the industry can relate to. His journey from analytical chemist to VP is full of valuable insights on leadership, career progression, and navigating high-stakes regulatory challenges. We talk about the following: 🔹 How he accidentally fell into quality after s...
Feb 05, 2025•44 min•Season 2Ep. 18
In this episode of Let’s Talk Quality , Hemish sat down with Rob Dallimore, Head of Quality at Wugen, to discuss his inspiring 25+ year journey in quality assurance and leadership. Rob’s experience spans small molecules, biologics, and cell therapy, giving him unique insights into what it takes to succeed across different modalities. Rob shared invaluable lessons from his career, including the mindset required to pivot into new areas of expertise, how to build resilient teams, and his experience...
Jan 22, 2025•46 min•Season 2Ep. 17
In today's episode, I'm joined by Jon Voss, one of the all-time quality greats! I've been working with Jon over the past 18 months. I'd describe him as a true gent - very humble, incredibly funny with a dry sense of humour, and someone who is so passionate about this industry. Unsurprisingly he has developed some of the leaders I've interviewed on this show! What shines through in this episode is the balance between pragmatism and patient safety. We talk about the following: The evolution of qua...
Jan 15, 2025•48 min•Season 2Ep. 16
On this week's episode of Let's Talk Quality: The Podcast🎙️ Hemish Ilangaratne is joined by Hanh Nguyen , Site Head of Quality at Minaris Regenerative Medicine , a global CDMO specializing in cell and gene therapies. Hanh’s career started in document control at Amgen, spending over a decade in Big Pharma, before taking a leap into smaller, fast-paced organizations. That move - stepping out of her comfort zone, was a pivotal moment that accelerated her growth and confidence as a leader. Hanh is ...
Dec 18, 2024•29 min•Season 2Ep. 15
On this week's episode of Let's Talk Quality: The Podcast🎙️ Hemish Ilangaratne is joined by Sang Yoon , VP of Quality Assurance at ImmunityBio , a cell and gene therapy company based in California. Sang’s story is truly inspiring. With 25+ years in biologics, medical devices, and healthcare, he’s been at the forefront of product launches, recalls, and scaling operations globally. But what stood out to me most was his approach to leadership: ✅ Build a community first ✅ Lead with trust, self-awar...
Dec 11, 2024•34 min•Season 2Ep. 14
On this week's episode of Let's Talk Quality: The Podcast🎙️ Hemish Ilangaratne is joined by Swetha Krishnan , Executive Director and Head of Quality at Mural Oncology , a fast growing biotech in Waltham, Massachusetts. Here's what they discuss: How Swetha's upbringing shaped her career progression 🚀 Moving from India to the US to pursue a career in science 🧬 Why wearing so many hats early on improved her confidence 👏 Why you don't always need all of the answers 🗯️ Balancing technical expert...
Dec 04, 2024•48 min•Season 2Ep. 13
In this episode, I had the privilege of speaking with Matthew Wheeler, Vice President of Quality and Clinical Operations at Precision BioSciences. Matthew’s journey is nothing short of inspiring. From starting his career in food manufacturing at Kellogg's to building a career in biotech, his story is one of resilience, adaptability, and leadership. In the past year, Matt was diagnosed with not one, but three rare diseases, including GPA vasculitis and IgA nephropathy. Despite these challenges, h...
Nov 27, 2024•45 min•Season 2Ep. 12
In this conversation, Lauren Smith, Chief Quality Officer at OrcaBio, shares her journey into the field of quality assurance, discussing her early career, leadership experiences, and the importance of connecting work to patient outcomes. She emphasizes the challenges and rewards of working in quality assurance, the significance of practical quality, and the need for purpose-driven leadership. Lauren also highlights the importance of employee development, self-awareness, and the impact of pivotal...
Nov 20, 2024•37 min•Season 2Ep. 11
Sean Smith, Vice President and Head of Quality at KSQ Therapeutics, shares his journey from working in big biotech to transitioning into small biotech and the challenges and opportunities that come with it. He emphasizes the importance of being willing to challenge the status quo, having an openness to learning, and practicing empathy as a quality leader. Smith also discusses the need for quality to be seen as an asset and the importance of building empowered and diverse teams. He encourages asp...
Nov 13, 2024•34 min•Season 2Ep. 10
In today's episode, I'm joined by Andrea Goddard, former Chief Quality Officer at Genentech. Andrea shares her career journey and insights into quality leadership. She started in biotech manufacturing and transitioned into quality after a conversation with her boss! Andrea emphasizes the importance of building strong relationships between quality and other departments within an organization. She discusses the challenges and rewards of working in a global role, including managing different time z...
Nov 06, 2024•37 min•Season 2Ep. 9
In today's episode, we're joined by Gary Barrera, Senior Vice President of Quality and Regulatory at Vera Therapeutics. Gary shares that his love for reading and learning, as well as his curiosity about how things work, led him to pursue a career in science. He started in manufacturing and eventually moved into quality, where he discovered his passion for ensuring the reliability and safety of products. We talk about the benefits of gaining exposure to different areas of an organization and how ...
Oct 31, 2024•42 min•Season 2Ep. 8
In today's episode I was joined by Andrew Cieri, Senior Director of Quality for Regeneron's newly acquired cell therapy unit. Regeneron are launching a new cell therapy unit after the acquisition of the pipeline and commercialisation rights to 2seventy products and Andrew has been tasked with launching this unit! I wanted to talk with Andrew to learn about his journey and how he's gone developing himself - both as a quality professional and leader. Chapters 00:00 Introduction and Background 03:5...
Oct 23, 2024•41 min•Season 2Ep. 7
In today's episode I'm joined by Laura Malagon, VP Quality and Regulatory at Grand River Aseptic Manufacturing. Laurie (as she is known as to those close to her) recently relocated from Miami to Michigan to lead the quality organisation at GRAM. She's had a fantastic journey in quality, starting her career washing glass-wear in a laboratory! We talk about the following: Relocating from Miami to Michigan this year for a new VP role. Laurie's journey into science and quality. Working with differen...
Oct 10, 2024•31 min•Season 2Ep. 6
In today's episode I was joined by James Myers, VP Quality at Spyre Therapeutics. I wanted to speak with James about his journey, starting in GCP focussed roles and learn how he transitioned into all encompassing GxP position. As a result James has gained exposure across GCP and GMP and developed himself as a true GxP quality professional. We discuss the following: Transitioning from GCP to GMP. Industry Trends. Gaining GMP Experience. Advancing to VP from director. Building a Team and Pilot Pla...
Oct 02, 2024•31 min•Season 2Ep. 5
Today I'm joined by Kelly O'Hare, current Vice President, Head of Quality at enGene, an innovative biotech developing a very exciting non-viral gene therapy focussed on bladder cancer. Kelly shares her journey in quality, discussing her transition from a technical writer to a quality leader. We talk about the importance of quality leaders being able to articulate the value of quality to their organizations. Her insights provide valuable lessons for aspiring quality professionals and leaders. Tak...
Sep 25, 2024•46 min•Season 2Ep. 4
In today's episode I was joined by Markus Gruell, SVP Quality at Autolus Therapeutics, a late stage clinical development CAR-T cell therapy company headquartered in the UK. Marcus, shares his journey in the industry and his role as VP of Quality at Autolus. We talk about his transition into the cell and gene therapy field and the challenges and opportunities it presents and move into his experience at Autolus, where he started as an associate director and worked his way up to SVP of Quality. Mar...
Sep 18, 2024•46 min•Season 2Ep. 3
Today I spoke with Sonia Razzetti, SVP of Quality at Disc Medicine, a clinical stage biotech focussed on developing therapies in the haematology space. Sonia shares her journey in quality and discusses the challenges she faced, including finding her voice in leadership meetings and aligning quality objectives with business priorities. Sonia is really open about the failures she has had to overcome which have helped her develop her career and others. Takeaways Finding your voice in leadership mee...
Sep 11, 2024•36 min•Season 2Ep. 2
We are back for Season Two of Lets Talk Quality! This week, I had the pleasure of speaking with Irving Ford, VP of Quality at Adaptimmune Therapeutics. Irving has been through the commercialisation of four cell therapy products, most recently leading Adaptimmune through the BLA and FDA approval of their engineered T cell for solid tumour, Tecelra. Irving talks about his journey from starting out his career as a Microbiologist before making his transition into the pharmaceutical industry. He star...
Sep 04, 2024•37 min•Season 2Ep. 1
Joe Franchetti, President of the Society of Quality Assurance (SQA), shares his vision for the SQA and the wider quality assurance industry, emphasizing the importance of collaboration and expanding relationships with international quality colleagues and regulators. Joe highlights the need to attract and educate younger professionals about the field of quality assurance. He discusses the role of technology, including AI and blockchain, the challenges and opportunities they present, as well as of...
Mar 13, 2024•38 min•Season 1Ep. 19
This is very special episode. I was joined by Laurie Adami, a financial services exec who was forced to give up her career after a cancer diagnosis in 2006. After a 12 year battle fighting follicular non-Hodgkin lymphoma, and six lines of therapy, Laurie received a call from her oncologist, informing her about a new therapy called CAR-T, that was being developed by Kite Pharma. They were opening a clinical trial at UCLA with five patients. Laurie was to be patient number one. One month after her...
Feb 22, 2024•1 hr 2 min•Season 1Ep. 18
In this conversation, Kimberly Wallbank, a quality systems consultant in the pharma & biotech industry, shares her insights and experiences in the world of contracting. She discusses the changes in the contracting market, the types of projects she takes on, and the shift towards remote and on-site work. Kimberly also provides advice on building a network and finding contracts, including the importance of volunteering and referrals. She emphasizes the need for flexibility, problem-solving ski...
Feb 15, 2024•31 min•Season 1Ep. 17
This week I speak with Stan Russell, who explains how quality leaders can create a function that adds true value to an organisation. Stan provides practical advice for leaders to change perceptions and measure the strength of a quality culture. He also shares his leadership style and the importance of storytelling and analogies in articulating quality to the organisation, which can result in a function that is seen as truly valuable. We discuss the following: What is a 'Quality Culture' and why ...
Feb 07, 2024•38 min•Season 1Ep. 16
This week I was joined by Vaishali Shukla, VP of Global Quality Manufacturing at Kite Pharma. "Act locally but think globally”. This is the mindset that Vaishali has helped instil in her role to help harmonize processes, engage the global network, and create a 'one team' quality approach. Vaishali talks us through her journey in quality and some of the challenges of leading a global quality operation of 500+ people, and the key aspects which have helped her to get to where she is now. We discuss...
Jan 30, 2024•27 min•Season 1Ep. 15
As a biotech professional, how do you know that the questions you ask 'experts' are accurate? Is the answer based on explicit regulations? Or is it based on personal opinion, which has been formed by historical organisational practise? In this episode, Greg Furrow, Chief Quality Officer of Mustang Bio, discusses his mission to raise awareness around the importance of industry 'experts' providing accurate and evidence-based information, rather than relying solely on personal experience or company...
Dec 20, 2023•34 min•Season 1Ep. 14
This is a story about the journey of commercialization for BMS' first cell therapies approved for the treatment of blood cancer. Jason 'Jake' Treese, played a critical role in the development, approval and commercialization of Abecma and Breyanzi; two cell therapies which have now treated 4,700 patients in clinical and commercial settings - patients that are often on their last line of treatment, and last hope of a successful treatment. We discuss leading the quality function in CAR-T cell thera...
Dec 07, 2023•46 min•Season 1Ep. 13
This week on the podcast I speak with Emily English, VP of Quality at Cartesian Therapeutics. Cartesian is a clinical-stage biopharmaceutical company developing RNA cell therapies designed to benefit the wide range of patients with cancer, autoimmune diseases, and respiratory diseases. We discussed RNA cell therapy and how Cartesian are bringing forward their mission of developing safer cell therapies for patients with autoimmune diseases. We talk about the following in detail: The work Cartesia...
Nov 29, 2023•30 min•Season 1Ep. 12
The volume of data integrity violations cited in FDA warning letters has risen alarmingly over the last decade. Several examples of poor data integrity practises have demonstrated the consequences it can have on a biotech's future, particularly when is occurs at an early stage of development. In episode 11 of Let's Talk Quality, I was joined by Brian Furmanski, Chief Regulatory Officer for Kriya Therapeutics. Brian has a large remit, covering regulatory, quality and clinical, and is passionate a...
Nov 09, 2023•30 min•Season 1Ep. 11
