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Operational Readiness and Cultural Excellence
Tue, 3 Jun
1345 – 1415
Operational Readiness and Cultural Excellence
Varun Choudhary, Moderna
As the Global Operations Readiness Manager at Moderna, I lead efforts to ensure readiness for pivotal commercial and global PPQ milestones. This role encompasses strategic alignment across programs to meet regulatory timelines, operational objectives, and commercial priorities. By building a cohesive global readiness framework, we can elevate our program management and operational execution to deliver excellence in PPQ processes.Objectives:Global Readiness Framework: Establish a scalable, standardized approach to support program readiness for PPQ across multiple markets and regulatory landscapes. Program Integration and Alignment: Enhance synchronization of program activities, bridging the gap between operational, regulatory, and commercial teams. Excellence in Execution: Foster a high-performing culture that drives operational agility and proactive risk management.
1415 – 1445
Operational Readiness and Cultural Excellence
Justin Cook, Sequence Inc
Jared Auclair, PhD, Northeastern University
Adam Sokolnicki, Millipore Sigma
In an era of rapid technological advancement and evolving regulatory landscapes, operational readiness is more than just having the right systems in place—it requires a strong culture that fosters innovation, adaptability, and continuous learning. How are leading organizations in the biotechnology industry cultivating environments that empower their teams to embrace change, drive innovation, and sustain long-term success?
This dynamic panel will bring together senior leaders from key sectors—biotechnology operating companies, engineering service providers, contract manufacturers, and university pilot facilities—to engage in a candid discussion about cultural excellence as a foundation for operational readiness. Panelists will share insights on:
- Building a high-performance culture that encourages innovation and agility in an evolving industry.
- Overcoming resistance to change by fostering a mindset of adaptability and continuous learning.
- Developing workforce capabilities to keep pace with cutting-edge technologies and new operational models.
- Bridging the gap between technical excellence and cultural transformation to drive long-term success.
Join us for an engaging conversation with industry experts who are shaping the future of biotechnology operations by prioritizing people, culture, and innovation.
This dynamic panel will bring together senior leaders from key sectors—biotechnology operating companies, engineering service providers, contract manufacturers, and university pilot facilities—to engage in a candid discussion about cultural excellence as a foundation for operational readiness. Panelists will share insights on:
- Building a high-performance culture that encourages innovation and agility in an evolving industry.
- Overcoming resistance to change by fostering a mindset of adaptability and continuous learning.
- Developing workforce capabilities to keep pace with cutting-edge technologies and new operational models.
- Bridging the gap between technical excellence and cultural transformation to drive long-term success.
Join us for an engaging conversation with industry experts who are shaping the future of biotechnology operations by prioritizing people, culture, and innovation.
1445 – 1515
Agile and Lean Technology Transfer to Take on the Next Pandemic!Recent infectious disease outbreaks such as the 2020-23 covid-19 pandemic and 2022-23 RSV epidemic have demonstrated how critical it is for the pharmaceutical industry to be ready to rapidly respond to these types of public health emergencies. An agile and lean approach to technology transfer is essential for the successful scale-up and launch of biopharmaceutical drug products under such highly pressurized and accelerated circumstances. The presentation will describe a strategic and nimble technology transfer methodology utilized during the COVID-19 and RSV crises, to enable the timely production of the urgently needed immunizations. Real-world examples are used to showcase how this agile and lean inspired approach can streamline the technology transfer process without compromising on product quality or introducing additional risk. Strategies for navigating the challenges posed by regulatory constraints will be discussed and attendees will learn best practices for ensuring operational readiness and maintaining flexibility across processes. This presentation will highlight the importance of developing a more robust and nimble technology transfer execution plan in readiness for the next national health crisis. Are you ready for it?
Speaker Qualifications
Speakers selected to present at ISPE events are leading professionals in their fields. However, it may be necessary to make substitutions. Every possible effort will be made to substitute a speaker with comparable qualifications. Every precaution is taken to ensure accuracy. ISPE does not assume responsibility for information distributed or contained in these events, or for any opinion expressed.
Agenda Changes
Agenda is subject to change. Last minute changes due to functional, private, or organizational needs may be necessary. The event organizer accepts no liability for any additional costs caused by a change of the agenda.