GxPodcast

Quality Culture and Excellence with Chris Lewis

Get ready for Episode 7 of the GxPodcast!
This week, we're joined by Chris Lewis, the Vice President of GMP Quality for Umoja Biopharma.
Prior to joining Umoja in 2021, Chris served in various Quality leadership roles at Amgen, Sandoz/Novartis, AstraZeneca Biologics, and AveXis/Novartis Gene Therapies, helping to bring life-changing clinical and commercial biologic, small molecule, and gene therapy products to patients and their families around the world. To enable the manufacture of these products, Chris has had the honor and privilege of supporting the startup of five separate cGMP manufacturing facilities, including the building of teams and organizations focused on establishing and maturing an effective quality culture and best serving one another to best serve patients together.
Outside of Umoja, Chris has a passion for supporting growth in the local biotechnology community, serving as the current President of the Mountain States PDA Chapter and as a Mentor in the Colorado BioScience Institute’s Mentor Program.
Tune in to hear us talk all things innovation and purpose. Looking at the automation of cell and gene manufacturing, industry regulations, and the power of purpose. 
#GXPodcast

Offshoring and Risk Management with Eckart Schwarz

It's time for Episode 6 of the GxPodcast!
This week, we were joined by Eckart W Schwarz, MD, President and Founder of a bespoke Life Science Consultancy, and expert in solutions and drug management. Eckart has 30+ years experience in leadership, designing and delivering global strategic and operational solutions. 
Eckwart has had an impressive career, from spearheading groundbreaking initiatives at GSK, including the establishment of a pioneering offshore R&D Capability Center in Bangalore, India, to the creation of innovative regulatory affairs delivery platforms. 
During his extensive work in leadership, Eckwart has been working on a vast collection of degrees from across the globe, including D.Sc. Hon Dr of Science, MD / M.B.,Ch.B. British Medical Degree, and FFPM (Hon) – 2022 Hon Fellowship, Faculty of Pharm. Med.. 
Tune into this new episode to listen to the insightful conversations we shared about the globalisation of drug treatment, tech breakthroughs, biopharmaceutical work and much more. 
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Compliance By Design with Carlos Yuraszeck

We're on episode 5 of the GxPodcast already!
In this episode, we're joined by a prominent figure in the pharmaceutical and biotechnology industries for nearly three decades, focusing on quality, compliance, and the manufacturing of advanced therapeutic products.
Throughout his journey, Carlos Yuraszeck has been instrumental in developing effective Quality Systems aimed at enabling Compliance by Design across the GxP spectrum.
Most recently, as the Head of GMP Manufacturing at the Astellas Institute of Regenerative Medicine, Carlos was responsible for various functions, including MS&T, Cell Manufacturing, and Engineering.
At Celgene, Carlos played a pivotal role in launching a groundbreaking treatment for Multiple Myeloma, contributing to the company's evolution into one of the most successful biotech companies. His expertise extends beyond product development to include building and running manufacturing facilities, understanding regulatory requirements, and collaborating with overseeing agencies. This unique combination of skills allows him to guide therapies from concept to patient treatment.
Prior to Celgene, Carlos held positions at Pfizer, Pharmacia, and Merck, where he gained experience in Quality Assurance, Quality Control, Validation, and Corporate Compliance.#GXPodcast

Balancing Compliance with Innovation with Vaishali Shukla

Welcome to episode 4 of the GxPodcast!
In this episode, we're joined by an industry expert, Vaishali Shukla, a proven leader with expertise in quality compliance and in developing the teams required to deliver it. In her current role as VP, of Quality at Kite, Vaishali leads 700+ professionals globally across multiple manufacturing sites. In this role, Vaishali oversees functional and site strategies at each of the Kite manufacturing locations, setting overarching goals and objectives as well as developing and executing short- and long-term strategic direction. With ~ 20 years of experience in the biopharmaceutical industry, she is an expert in a broad variety of subjects ranging from early clinical development to commercialization of Cell and Gene therapy, biologics & small molecules. Vaishali’s career includes work at BioVest International, Takeda Pharmaceuticals, Shire Pharmaceuticals, and UniQure, where she implemented novel processes for continuous development. With a BS in Biology, master’s degrees in Botany, Regulatory Affairs, Pharmaceutical Economics and Policy, and a Ph.D. in Pharmaceutical Science. Vaishali lives in the Boston area and is the proud mother of her daughter Smita, who is following in her footsteps as a female trailblazer in the biosciences.#GXPodcast

Quality Systems Remediation and Culture Transformation with Joseph Chi

Welcome to episode 3 of the GxPodcast!
We're excited to be joined by Joseph Chi, a renowned quality and compliance advisor and expert with over 20 years of experience in global environments, from small biotech firms to large pharmaceutical and medical device businesses. Joseph excels in leading projects for compliance, remediation, and process implementation. With special expertise in quality and compliance management, quality systems, audits, and ISO standards as a certified auditor, he's not just a leader, but also a mentor skilled in team training and project leadership. An expert in international regulations like EUMDR and pharmaceutical and medical device regulations - Joseph's insights are invaluable to anyone within the industry.
Let's dive in.

Enterprise Systems Harmonization with Alisa Pukhovich

Welcome to episode 2 of the GxPodcast!
In this episode, we have a conversation with Alisa Pukhovich. Alisa is an expert in pharmaceutical development with over 25 years of experience. She is a Subject Matter Expert (SME) in Global Submission Management, Electronic Filings, Compliant Data Management, and Regulated Environments. She also has extensive experience in the implementation and validation of computer systems. Alisa has led diverse, cross-functional teams in obtaining regulatory approvals for drug applications filed by startups and large pharmaceutical companies.
Currently, Alisa works as a consultant, where she assists enterprise clients in achieving their business goals by assessing their current state and providing business solutions, training, systems, and documentation enhancement proposals to ensure better systems user adaptation.
Let's dive in.

Pharma 4.0 and Push for Paperless with Jamie Leary

Welcome to Episode 1! Jamie Leary is a man who has 16-plus years in the pharmaceutical industry and has spent an equal amount of his time in manufacturing, technical operations, and quality roles. He has extensive experience leading teams as the project manager on hypercare initiatives, remediation initiatives, tech transfers, facility startup, and operational readiness. Listen in as we discuss Pharma 4.0 and the move toward paperless operations in the space of Life Sciences.