MBS Alumna Stephanie Lee Earns Outstanding Early Career Professional Award, Celebrating Contributions to the PDA and Flourishing Career at Amgen

Keck Graduate Institute (KGI) alumna Stephanie Lee, MBS ’21, recently won the Outstanding Early Career Professional (ECP) Award from the nonprofit Parenteral Drug Association (PDA), the leading global provider of science, technology, and regulatory information. The award honors Lee’s many contributions to the PDA—where she currently serves as West Coast Chapter President—and the biopharmaceutical industry.

Lee first became involved with the PDA Southern California (SoCal) Student Chapter as a student in KGI’s Master of Business and Science (MBS) program, serving as President-Elect and then President during her time at KGI. She initially joined because she felt it would be an excellent opportunity to learn more about the industry.

“They cover many topics, including regulatory, quality control, risk, and data integrity,” Lee said. “The more I’ve gotten involved, the more I’ve learned. Also, the PDA SoCal Student Chapter provided a unique opportunity to connect directly with, network, and collaborate with industry professionals. Not only did we work closely within the student chapter, but we also worked with the parent PDA SoCal Chapter to put on industry events.”

Her involvement in the PDA has enabled her to meet many people who share her goals and interests. After graduating from KGI, she moved back to the San Francisco Bay Area—where she is originally from—and became involved with the West Coast Chapter, taking over as President at the beginning of 2023.

Around that time, Cylia Chen Ooi, who is on the PDA Board of Directors and was Lee’s industry mentor while she was at KGI, told Lee about the organization’s inaugural Early Career Professional (ECP) Mentorship Program, which had started in June 2022. Lee joined, where she was paired with Jason Kerr, KGI alumnus and 2022 winner of the ECP award, who served as her mentor in the ECP Mentorship Program.

Lee interviewed chapter leaders from the 24 local chapters worldwide and compiled a PDA Guidebook, completed in April 2023. It was Lee’s work on the guidebook and with the SoCal Student Chapter and West Coast Chapter that contributed to her winning the 2023 ECP award, which she was presented with at the PDA Annual Conference in April.

She feels that the industry experience gained during her time with PDA has been well complemented by her experience in KGI’s MBS program, where she concentrated on Biotech Management while also receiving a Bioscience Industry Law and Practice Certificate from Southwestern Law School. 

“I liked how the MBS program emphasizes bridging science and business,” Lee said.

She appreciated learning from her professors, particularly Henry E. Riggs, Professor of Management Dr. Steven Casper, and Dr. Joel West, MBS Program Director and Professor of Innovation and Entrepreneurship.

“We had a lot of group projects,” Lee said.

“When going into the workforce, everything is about collaboration. So KGI prepared me well for that.”

She also enjoyed participating in the Team Master’s Project (TMP), where students gain real-world experience by collaborating with a biotech company on a specific issue. In her case, she got to work with both Gilead and Amgen.

After working for a semester with Gilead, she had two opportunities to work with Amgen—first as a graduate intern in global operations planning and then as a graduate student consultant in clinical risk mitigation and management. These collaborations eventually led to full-time employment at Amgen, where she now works as a Chemistry, Manufacturing, and Controls (CMC) Integration Project Manager in Process Development.

“As a project manager, I am the ‘glue’ that holds the team together,” Lee said. 

She works cross-functionally with various teams (including drug substance and drug product, CMC regulatory affairs, supply chain, partnership management, manufacturing, engineering, variations management, and combination product operations) to optimize development strategy and ensure that everyone delivers upon their agreed-upon schedules, timelines, and work streams.

“I have a cool opportunity to work with people in these different areas to drive continuous improvement for the programs that I’m on, as well as working with my leads and directors to bring that strategy forward,” Lee said.

Lee plans to continue working in roles where she can help advance drug development and commercialization, ideally working in Global Operations.

“Ultimately, we’re trying to get these life-saving medicines to patients when they need it—our mission at Amgen is to serve ‘every patient, every time,'” Lee said. 

Lee’s work with the PDA reflects her current role’s diversity and career trajectory.

“Their scope is much broader than their title (parenteral drugs, which are delivered via injection or infusion) suggests,” Lee said. “They deal with the quality and regulatory aspects of the industry, as their mission is to connect people in science and regulation. However, they cover many other topics as well.” 

Events held by the PDA West Coast Chapter recently include Cell and Gene Therapy and Women in Life Sciences.

“PDA has been a great opportunity for me in my career growth,” Lee said. “Leading the West Coast Chapter has been a lot of work, but it’s also very rewarding. I am grateful for the experience.”

Casper applauds Lee’s contributions to KGI and her cohorts in the MBS program.

“Stephanie Lee was an outstanding student and leader at KGI,” Casper said. “While serving as President of our local PDA chapter, Stephanie worked tirelessly to create opportunities for KGI students to network with local industry professionals. We are proud of her accomplishments at KGI and wish her all the best as she continues to develop her professional career at Amgen.”