Selecting the best-fit people from the outset lays the groundwork for long-term success. A strong team will not only tackle today’s challenges but also anticipate and overcome the inevitable challenges ahead. Look for innovative problem-solvers who thrive in dynamic environments, adapt to evolving needs, and drive meaningful progress. With the right team in place, your cell therapy journey will be positioned to deliver favorable results.
"Success starts with the right people. I believe in hiring top talent and trusting them to do their jobs because they are the experts. In a field where the right expertise drives breakthrough cell therapies, our role as leaders is to provide guidance, remove obstacles, and create an environment where teams can thrive." – Ria S. Barrett, Sr. Director & Head of Human Resources
Your technical, process development, and analytical teams will serve as the backbone of your project. As you move toward manufacturing, a robust MSAT team is critical. Ensure you have experts who understand GMP requirements, regulatory guidelines, and manufacturing operations while working closely with your quality team.
Do not underestimate the importance of a strong logistics and supply chain team. Their role involves managing raw materials, coordinating shipping vendors, and overseeing complex scheduling, all of which are essential for smooth operations.
If your team lacks expertise in CMC and/or what is required from a quality and compliance perspective for product release and process control, address this gap immediately. Engage a dedicated advisor who can support both you and your manufacturing partners, or bring in a full-time hire or consultant to manage this function.
Additionally, if you are partnering with a CDMO, strong project management on both sides is non-negotiable. Clear expectations, well-documented processes, and rigorous tracking of activities, decisions, and timelines will be essential for success.
“Effective project management is at the crux of a cell therapy program. From aligning cross-functional teams to ensuring seamless execution, it’s about driving clarity, accountability, and momentum at every stage of development.” Michelle Ng, Sr. Director & Head of Portfolio & Program Management
Whether you manufacture in-house or partner with a CDMO, leveraging advanced tools and equipment is key to optimizing production. If your team lacks direct experience with certain technologies, collaborate with industry leaders who can introduce you to cutting-edge solutions.
By combining your expertise with that of scientists and engineers developing novel manufacturing platforms, you not only refine your own processes but also contribute to the advancement of the industry as a whole.
From pre-clinical support to Phase I-III clinical trials and commercial enablement, we collaborate with cell therapy developers for a seamless, science-driven approach to development, manufacture, and release of product.
Each project at Made Scientific is supported by a dedicated core team of subject matter experts and led by an experienced project manager, ensuring a consultative partnership focused on success. Our adaptable and resourceful strategies deliver high-quality outcomes, on budget, and on time.
Interested in hearing more? Let’s talk.