Introduction
Hi there! My name is Claire. I was born and grew up in Taipei City – the capital of Taiwan. I hold a master’s degree in Bioengineering, and I’m currently working at a biotech company in Boston. If you’re considering pursuing a STEM degree and looking to work in the State after graduation, then you might find some useful information in this article.
Growing up with a passion for Biology, I earned my Bachelor's degree in Biomedical Engineering in Taiwan. I completed an internship at Beckman Coulter (Taiwan branch) and conducted research to develop the sprayable thermosensitive chitosan-based hydrogel. This material is liquid at low temperature and solidifies into a barrier at body temperature designed to prevent irreversible abdominal adhesions caused by surgery.
To broaden my career opportunities, I decided to move to Boston (a.k.a one of the largest pharm/biotech hubs in the US) in 2019 to pursue my master’s degree in Bioengineering at Northeastern University. Instead of co-op (limited open positions due to COVID), I chose to do thesis for my graduate path. For my graduate thesis, I worked on developing a pharmacokinetics model to determine the optimal lipid/surfactant ratio in drug development. I investigated the mechanism of surfactant effect on dynamic processes governing drug absorption in vitro; used mathematical equations to represent drug-lipid-surfactant interactions; and incorporated these equations to predict the concurrent effect of lipid and surfactant on overall drug absorption. This experience strengthened my research skills (experimental design, data analysis, data interpretation) and lab skill (HPLC).
After graduating, I joined Editas Medicine as a Senior Development Associate in Cellular Process Development, marking my entry into the world of Cell Therapy. I worked on EDIT-202 program – an allogeneic cell therapy for oncology. The responsibilities of Process Development Team included developing the differentiation process by guiding pre-edited iPSC into mature iNK cells (60+ days), scaling-up the differentiation process in bioreactors (up to 50L), and driving the differentiation process from research-grade to clinical-stage. After a year and half, I joined Clade Therapeutics as a Process Engineer II working on a similar project, but we focused on iPSC-derived CART cells differentiation.
To this day, I’m still committed to Cell Therapy. However, instead of immunotherapy for oncology, I’m currently working at Somite Therapeutics – a biotech/AI company dedicated to developing iPSC-derived myogenic satellite cells for Duchenne Muscular Dystrophy (DMD), a rare disease characterized by progressive muscle degeneration and weakness due to genetic disorder.
Biomedical Engineering Fellow
career options
Biomedical Engineering Fellow
skills
What are the main hard skills you use on a daily basis in your current job?
It is fundamental to have a solid knowledge of the field you wish to work in. For instance, if you want to work for a cell therapy company, understanding of stem cell regeneration and genomic editing is essential. Conversely, if you are aiming to work in CMC, familiarity with regulatory requirements, such as Good Manufacturing Practices (GMP), FDA regulations, and International Council for Harmonisation (ICH) guidelines, is required.
Experimental design is often more complex than it appears. A well-designed experiment must consider parameter design, result accuracy, statistical analysis, feasibility of execution, and even the potential follow-up experiments based on each possible outcome. Conducting research efficiently within limited time, budget, and resources is important in biotech. Operating bioreactor/lab equipment and running bioassays is a plus (which is nice to have but you can learn after); while a solid concept of experimental design is basic for a process engineer, and you will use this skill in your day-to-day job.
As a process engineer, you need to summarize the results from various experiments into technical reports and present your findings along with recommendations for the next steps in small team or company meetings. Additionally, part of the job involves (1) writing Standard Operating Procedures (SOPs) for tech transfer to internal/external collaborators, and (2) drafting CMC-related documentation (such as Master Batch Record, Raw Material Risk Assessment, Bill of Materials, and Development Report) for IND application filings or other regulatory purposes.
What are the main soft skills you use on a daily basis in your current job?
Driving a drug product from laboratory research to commercialization is a lengthy and complex process involving multi-functional teams. The ability to work in a team environment, respect different perspectives, and integrate various fields of expertise is crucial. As a process engineer, I collaborate closely with (1) R&D team for process development and optimization (2) AD team for supporting assay validation, (3) manufacturing team for process tech transfer, (4) QC/QA team for documentation and regulatory compliance.
Typically, a bio-experiment can take a week (or even more than two months for iPSC-derived cell therapy). Given this, effective time management and multitasking are vital skills to ensure that project milestones are met on time without compromising quality. For example, as a process engineer, you might have three experiments running simultaneously, along with various internal/external meetings and collaborative activities with other teams – how do you arrange your day to manage these tasks effectively without working overtime?
The pharmaceutical and biotech fields are dynamic and rapidly evolving – frequent changes in corporate goals and strategies are not uncommon. Being adaptable helps you respond effectively to unexpected changes and challenges. Flexibility in mindset and ability to learn new approaches or techniques are essential for navigating these uncertainties and shifts in project scope.
Claire
’s personal path
Tell us about your personal journey in
Biomedical Engineering Fellow
:
I graduated in 2021. Without co-op or internship experience, my resume was less competitive in the job market as a recent graduate; and the gap in knowledge between academia and industry left me uncertain about which positions i was interested in pursuing.
I submitted over 100 applications in total, had 25+ phone screenings with HR and around 10 panel interviews (typically you will be meeting with the hiring manager and 4 to 5 team members or colleagues you would be working closely with). The hiring manager from my first job contacted my master’s advisor for a referral of talented graduate students, and my advisor recommended me. Due to the connection, the hiring manager skipped the HR phone screening, directly reached out to me for an introduction, and then scheduled a panel interview with the team. Despite my limited experience in cell therapy, I demonstrated a strong passion for learning new knowledge and technologies, as well as the ability to work in a team environment. Finally, I got the job at a mid-size biotech company. The first three months were particularly challenging due to the fast pace of biotech industry compared to academia, especially since I had no prior understanding of stem cell culture, differentiation and process development. However, overall I enjoyed my first job a lot and appreciated to have great colleagues and gain extensive experience, learning many new skills along the way.
Unfortunately, the company decided to reorg and sell the pipeline I was working on, which lead to layoffs for our entire team. My manager left the company before the layoff. She recruited one of my colleagues and me to join her new team at a starup. Because of the company size was much smaller, in addition to applying my previous experience in developing upstream iPSC differentiation process, I was exposed to various different things such as downstream process development, efficacy bioassays, and drafting regulatory related documentation. After a year, the starup struggled with Series B funding and was acquired by another company. Due to the acquiring company’s corporate strategies, the entire CMC team (Process Development, Analytical Development, Manufacturing, and Quality) was laid off.
Thankfully, I found my current job at the last minute. This starup, founded in 2024, is relatively young and needs someone who cannot only perform wet lab work but also take on some management responsibilities. Unlike my previous work in immunotherapy for oncology, we’re now doing iPSC-derived muscle cells for Duchenne Muscular Dystrophy (DMD) disease. I’m in the process of becoming an expert in muscle cell differentiation while still applying my skills in experimental design and problem-solving in my daily work.
What would you tell your younger you regarding building your current career?
Connections are much more important in the industry than you might imagine. Don’t be too shy to engage with others at networking events. Ask questions whenever you don’t understand something; no one will laugh at you. Read pharm/biotech news daily and talk to people in your field more frequently to stay updated on industry trends.
Final thoughts & tips
Finding a job in the United States is always challenging for international students due to the added expense of immigration sponsorship for employers. However, don’t be discouraged or overwhelmed by rejections during your job search. Focus on being well-prepared yourself (such as having professionals review your resume and practicing for interviews), keep applying and learn from each interview experience. So that you can perform confidently when you meet your dream job. Remember, chance favors the prepared mind.
Resources to dig in more
Biomedical Engineering Society (BMES)
Biomedical Engineering Society (BMES) is a professional organization that provides a networking platform for students, researchers, and industry professionals working in the broad field of biomedical engineering. Their paid membership offers access to the annual meeting, workshops, professional resources, and networking events.
BioSpace
BioSpace is a digital hub delivering in-depth news and insights on the biotech and pharmaceutical industries. It’s a nice source for daily updates on industry trends, company news, and regulatory developments.
Boston Taiwanese Biotechnology Association
Boston Taiwanese Biotechnology Association (BTBA) is a non-profit organization held by a group of Taiwanese students, researchers, and pharm/biotech professionals in the greater Boston area. It offers annual symposium, weekly workshops/seminars, podcasts, and mentor-mentee programs to support individual career development and foster networking between academic and industry.
