Angela Au G’05 G’11 has loved science as far back as she can remember. Completing both her master’s and Ph.D studies in the biomedical program at the College of Engineering and Computer Science, she now works as the Associate Director of Manufacturing Technology at LOTTE BIOLOGICS. In this one-on-one interview, Au gives insight into her career path, her current role at Lotte Biologics and how she discovered her passion for her field.
What sparked your interest in Syracuse’s biomedical engineering program?
I completed both my M.S. and Ph.D. in Bioengineering through the Department of Biomedical and Chemical Engineering at Syracuse University, taking a break in between the program. My Ph.D. was completed part-time at SU via a non-traditional scenario while working full-time as a Research and Development manager at Nutramax Laboratories, Inc. down in Baltimore, MD after completing my M.S.
My journey to SU followed completion of my undergraduate studies at the Johns Hopkins University (JHU) where I majored in Biomedical Engineering and double majored in Mathematical Science, with a minor in Entrepreneurship and Management. As an undergraduate, I was fortunate to have had the opportunity to work in the JHU Department of Orthopedic Surgery laboratory where my biomedical-based research was largely focused on biomaterials. There, I was involved with evaluation of toxicity from wear particles from hip implants. My second project involved evaluation of thermo-reversible polymers for cartilage repair. Through immersion of these projects at Hopkins focused on understanding the impact of the cellular environment and stimuli on the cellular milieu, I discovered this was a field that I wanted to learn more about and dive more into. I applied to several different graduate programs which had strong biomaterials programs, of which SU had a long-standing Bioengineering program with some phenomenal faculty with diverse research interest. SU also had a biomaterials program with a focus on both hard and soft biomaterials, including polymer research.
My decision to attend SU was based on a chance encounter at the Society for Biomaterials conference, where I met Dr. Julie Hasenwinkel and a few of her graduate students working in her laboratory and the Biomaterials group with Dr. Jeremy Gilbert. The enthusiasm and passion they had for the program, SU, and the innovative research into orthopedic materials including hip implants and bone cement, as well as materials for spinal cord regeneration solidified my decision to attend SU over other programs.
Did you always want to be an engineer?
I think I’ve always had an engineering mindset and it was a natural choice for a career. According to my parents, even as a toddler, I have always gravitated to and enjoyed tinkering with puzzles, solving math problems, and had a curiosity for understanding how things worked around me. I have always loved science, particularly biology, chemistry, and physics and my favorite course even in high school was Calculus. I’m a quintessential nerd and lean into that being who I am. I actively participated in Odyssey of the Mind starting in middle school and was President of the Science Olympiad club in high school, where I enjoyed competing the most in areas involving solving problems, building contraptions, and designing and building weight-bearing balsa wood towers and bridges.
I was first introduced to Biomedical Engineering by my 11th grade Biology AP teacher. I knew I wanted to make a difference in a medical-related field but did not want to go directly into medicine as a practitioner. He suggested biomedical engineering as an option, where I could combine my love of solving problems by generating innovative solutions, while still focusing on the life sciences to bridge my passion to help others via an indirect route.
What is your role at LOTTE BIOLOGICS?
I currently wear many hats as the Associate Director of Manufacturing Technology/Manufacturing Science and Technology. There is a technical component, a strategic component, and a leadership component. In order to be proficient in my typical day, all three components are needed. Generally, my current role involves serving as a product steward across the process and analytical lifecycle. This includes working with clients and supporting our business development teams to support technical discussions. Having worked in multiple roles across process development, later process stages, through commercialization, as well as Quality Control, this has established a great foundation across multiple areas pivotal to the biopharma lifecycle. Currently, my role is to provide leadership and guidance for those working directly in Process Development, Process Characterization, and managing the technology transfer of processes from client programs from laboratory-scale to manufacturing-scale.
The role includes developing technical strategies, along with supporting growth and development of the organization. The breadth of activities and deliverables on a given day keeps things exciting. This could involve developing a new process once provided with a new cell line (research cell bank), developing and optimizing the operating and process parameters, evaluating and optimizing media formulation, screening resins, establishing statistical Design of Experiment (DoE) studies to support robust design spaces, and executing process validation. The team also executes feasibility runs with client processes to ensure minimal impact as part of the transfer between scales and from the client and also support Toxicology, Clinical, and Commercial batches. Once a process is ready for transfer to the manufacturing scales, the team supports troubleshooting via routine trending of process performance and quality attributes, providing technical guidance for forward processing, spending time on the manufacturing floor, and also completes deviations and root cause analysis investigations, while implementing robust corrective and preventive action, as appropriate to ensure robustness of the client material.
Other aspects include evaluation materials and consumables as part of the process stream, performing risk assessments to ensure safety of the product and ultimately, efficacy of the biopharmaceutical product. The team works to also trend and analyze data from multiple systems, building and leveraging data analytics programs and visualizations to facilitate real-time data evaluation between laboratory-, pilot-, and manufacturing-scales. As part of supporting GMP operations, we also lead and complete deviations and root cause analysis investigations where we leverage our sleuthing skills and technical expertise to drill down to the source of a deviation or issue. As scientist and engineers, we work across teams to also develop solutions for corrective actions and preventive actions for process, equipment, and analytical robustness.
Beyond the technical and strategic side, which I really enjoy, I am most fulfilled by my role on being able to support and influence others. This is associated with supporting others through direct mentoring and coaching others, or through building other’s confidence and technical acumen, whether they are on my own team, as well as those from other functional teams. This enables growth within the organization to support learning new skills and also developing new people leaders, whether direct people leaders or those leading cross-functional teams.
What projects are LOTTE BIOLOGICS currently working on?
LOTTE BIOLOGICS continues to provide biopharmaceuticals for our clients. Additionally, LOTTE BIOLOGICS has invested in building an antibody drug conjugate (ADC) facility at our Syracuse Bio Campus, which also includes QC laboratory, and process and analytical development laboratories. This has been a huge endeavor over the last year and a half to bring this newer modality to the site to harness the protein/antibody via bioconjugation using specific types of chemistry to better deliver the potent compound such as a chemotherapeutic agent (therapeutic drug payload) to the cancer cell. At a high level sample scenario, the antibody serves as the missile to deliver the conjugated linked drug specifically to a targeted cancer cell for destruction. This reduced the side effects typically seen with general systemic administration of the drug since the ADC is a more targeted approach for the patient to attenuate the response. We plan to have the ADC facility ready for manufacturing in early 2025. This is in addition to our current manufacturing capability here in Syracuse of 5,000 Liter scales.
We are also in the process of implementing a new laboratory to support the Sartorius AMBR 250 high-throughput automated system to facilitate process development through later process characterization studies. The system will enable use of these smaller scales and volumes to enable process scale-up to larger bioreactor scales. Leveraging process engineering principles, we can design and execute experiments to build process understanding while coupling this with our larger laboratory-scale bioreactors.
Additionally, as part of the business expansion and capabilities in the CDMO space, LOTTE BIOLOGICS recently had the groundbreaking in building a Songdo Bio Campus in Songdo, Korea which will house even larger scale production bioreactors at the 15,000 Liter scales to facilitate our ability to provide increased bioreactors for multiple clients at multiple scales. This will include 3 different plants to supplement and further increase the capabilities at the Syracuse Bio Campus. It has been great to collaborate with our colleagues in Korea on new endeavors as the business continues to expand.
What do you love most about your role?
I love that I am able to work with great people every day to solve scientific and technical problems. There is innovation all around me daily as we face new challenges in terms of how we scale-up a process to how we work around a deviation in our manufacturing facility. This requires both inside the box, as well as outside-the-box thinking. The people I work with is also key to my role. I work with phenomenal scientists, engineers, bioprocess associates on the manufacturing floor, as well as folks across other organizations in non-science-based fields that allow me to keep growing as an individual, while also supporting my personal journey for lifelong learning in finance such as budgeting, business development, to supply chain and logistics, to name a few.
What future do you see for Lotte Biologics?
LOTTE BIOLOGICS strives to be a top 10 contract development manufacturing organization (CDMO) in a very competitive market and field of biopharmaceuticals. As there are so many medicines that need to be brought to patients quickly and with a high degree of quality, LOTTE strives to help other companies in their journey to achieve this goal.
What advice do you have for students who may want to pursue similar careers to yours?
First, engineering can be hard. The coursework is rigorous, and at times, it can be discouraging. Use this time to learn and really take in the basics. These courses help build the foundation where you continue to add on new layers over time and you can always go back to the foundations. You don’t need to know everything.
Second, I would suggest taking opportunities as they arise even if they may not seem to align with your original career path or ideal job for what you thought you would be doing after graduation. Although I had started my education believing I wanted to work primarily on soft biomaterials, I took the chance to work in an industry very different from a typical biomedical device company. There, I was able to leverage my understanding of materials and cell-based knowledge to engineer in vitro models to understand if specific agents would reduce inflammation and oxidative stress on different cell types. This provided me with a foundation and ability to learn the intricacies of how industry worked, while also continuing to build my leadership capabilities and network. I also never considered working in the biopharmaceutical industry, but 13 years later, I still love being able to develop new bioprocesses in bioreactor tanks and purifying these through different materials. When opportunities came up, I took the leap although I wasn’t the expert and have worked in different areas including leading a Quality Control bioanalytical team to continue expanding my personal capabilities through developing strategies for team execution while not being the subject matter expert.
Third, I suggest identifying a great mentor. I was fortunate enough to have a phenomenal undergraduate research advisor, who continues to be a mentor to this day, who actively supported her student’s growth and development. She was an advocate for her students by sending students to present their work at conferences and publishing in research journals. She provided career advice, as well as personal advice. Throughout my career, I have also had additional mentors to support me in different stages of what I needed in my career in how to navigate the complexities.
What do you like to do for fun?
My husband is a retired Air National Guardsman who grew up in Syracuse, NY, so he’s quite an adventurist who loves the outdoors. For fun, he has pulled this southerner (Houstonian) into a plethora of outdoor activities. In the winter, we enjoy downhill skiing and in the summer, we enjoy boating on Oneida Lake and are fortunate is only a few miles from our house. We are also only a short drive away from the Adirondacks and Finger Lakes where we frequent wineries, breweries, and get out on the boat. More recently, I have started golf lessons to dive into a new sport. Aside from spending time outdoors, I read a lot of non-fiction books on leadership and also scientific articles to stay up to date on industry trends.