Tell us about your experience in leading scale-up and tech-transfer activities from lab scale to production scale.

In my previous role as a Senior Cell Culture Scientist, I have extensive experience in leading scale-up and tech-transfer activities from lab scale to production scale. I have successfully managed multiple projects and met deadlines while ensuring adherence to cGMP standards and regulatory guidelines. I have collaborated with cross-functional teams to integrate cell culture processes with overall product development, and have optimized cell line development and culture conditions to improve yield and quality. Additionally, I have mentored and trained junior scientists and technicians in cell culture techniques. My strong record-keeping and organizational abilities have allowed me to prepare and review scientific reports, SOPs, and quality documents. I stay current with advancements in cell culture technology and apply new findings to enhance process development.

In my previous role as a Senior Cell Culture Scientist, I have successfully led several scale-up and tech-transfer activities from lab scale to production scale. For example, I oversaw the transfer of a cell culture process for a new product from the lab to a 200L bioreactor for large-scale production. This involved coordinating with process engineers, manufacturing teams, and regulatory experts to ensure a smooth transition. I also implemented process optimizations during the scale-up, resulting in a 20% increase in product yield while maintaining high quality. Additionally, I have mentored and trained junior scientists and technicians in cell culture techniques, providing guidance on process scale-up and troubleshooting. Overall, my experience demonstrates my ability to lead and manage scale-up and tech-transfer activities in a compliant and efficient manner.

In my previous role as a Senior Cell Culture Scientist, I led a major scale-up and tech-transfer project that involved transitioning a cell culture process from lab scale to a 2000L production bioreactor. This project required close collaboration with process engineers, manufacturing teams, and regulatory experts to ensure the successful transfer of the process while maintaining cGMP compliance. I developed a comprehensive project plan, including risk assessment, process validation, and documentation, to mitigate potential challenges. During the scale-up process, I identified process optimizations that significantly improved product yield and quality. For example, by modifying the feeding strategy and optimizing cell culture conditions, we achieved a 30% increase in product yield without compromising purity or functionality. I also implemented real-time process monitoring and control strategies to minimize variability during scale-up. As a result of these efforts, the project was completed ahead of schedule and within budget, with seamless tech-transfer and successful production at the larger scale. I also provided leadership and guidance to a team of scientists and technicians throughout the project, ensuring effective communication and collaboration. Through regular team meetings, training sessions, and feedback sessions, I facilitated knowledge transfer and skill development for the team members. My experience highlights my strong leadership and problem-solving skills, ability to adhere to regulatory guidelines, and effective collaboration with cross-functional teams.