This person is an experienced Biopharmaceutical Program Manager with a strong background in gene therapy and biosimilar pipelines. They have expertise in early-, mid-, and late-stage drug and biologics development processes, chemical methodology, and proteins analytics. They are skilled in managing external partners, vendors, CMOs, and CROs, while collaborating effectively with internal cross-functional teams. They have a proven track record of driving strategic CMC advancements and optimizing business processes, ensuring compliance with FDA guidance, ICH, and other relevant quality standards. They hold an MS in Biology and Biochemistry, as well as a Certification in Principles and Practices of Regulatory Affairs from Northeastern University. They are highly organized, capable of multitasking in fast-paced environments, and fostering a culture of innovation. They are proficient in project management, with excellent communication and collaboration skills.