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Insights

Q&A with Joe Micsko, Director, Operational Readiness

Joe Micsko Profile photo
Insights

Q&A with Joe Micsko, Director, Operational Readiness

What inspired you to pursue a career in the biotech/pharma industry?

A: I have always been driven by a profound desire to help people, and I believe this industry is the ideal path to fulfill this passion. This industry not only allows me to pursue my passion for helping others but also provides a platform to drive meaningful advancements in healthcare, ultimately improving the quality of life for countless individuals worldwide.

Can you tell us about a project or achievement you're particularly proud of in your career?

A: One of my key successes was advancing an allogenic CAR-T facility from construction to process performance qualification (PPQ) in just 18 months. This was achieved through close cross-functional collaboration, agile project management, and proactive risk mitigation. Efficient resource allocation, continuous stakeholder communication, and advanced technology-enhanced accuracy and kept us on schedule. By focusing on quality, ongoing team development, and early client engagement, we ensured all requirements were met, ultimately delivering a high-quality outcome on a tight timeline.

How do you define operational readiness, and why is it so critical to the success of our projects at IPS?

A: Operational readiness involves a comprehensive approach that I refer to as the 3Ps: People, Process, and Plant.
People are the foundation of operational readiness. Having the right talent, and ensuring their engagement and development, is essential.
Streamlining processes are key to successful product development and manufacturing.
Ensuring the readiness of your plant is crucial for operational success.

What are some of the key challenges you see in operational readiness and tech transfer?

A: Technology transfer and operational readiness are both vital but unique steps in launching successful operations. Tech transfer moves knowledge, technology, or processes from one team to another, while operational readiness ensures all systems, processes, and personnel are fully prepared to operate effectively.

Challenges in both areas include meeting strict regulatory standards, scaling production smoothly, ensuring strong cross-functional collaboration, and managing resources. Effective strategies—like clear communication, rigorous training, and proactive risk management—are essential to overcoming these hurdles and achieving seamless, reliable operations.

Can you share your vision for the future of operational readiness at IPS? What are some goals you’re excited to achieve?

A: Our vision for operational readiness is simple: integrate People, Process, and Plant to empower clients to adapt quickly, innovate, and thrive. We're focused on building a skilled team, delivering tailored solutions, and forming long-term partnerships. By creating adaptable frameworks and gathering feedback, we’re committed to continuous improvement. Our goal is to expand market reach, demonstrate impact with real metrics, and keep our clients ready for every challenge.

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