Ten minutes with Shauna McCabe, WuXi Biologics

"If you don’t understand why or how something is done the way it is, ask why," advises Shauna.

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How did you get started in WuXi Biologics?


WuXi Biologics allowed me, along with so many others the opportunity to relocate home. After completing my undergraduate degree I was forced to move away from home in order to follow my career. There were no opportunities within the biopharma industry that were within commuting distance to me in the north east. I was working in Cork for 13+ years when the opportunity to work in WuXi Biologics became available. I sold my house and relocated my family back up home to be closer to my family and friends.


My leadership role within WuXi Biologics naturally followed as I joined the project at such an early stage. We had products lined up for the facility prior to construction so we were faced with the challenge of facility fit, Technology Transfer, commissioning and qualification all at once. There were plenty of projects to lead and roles to grow into.


Why did you choose to work for WuXi Biologics? In what way have your expectations been met?


WuXi Biologics is Ireland’s only Contract Research Development Manufacturing Organisation (CRDMO). We manufacture biologics for companies that don’t have sufficient capacity to meet their own demands or in some cases the client may not have a manufacturing facility of their own. As a result, we manufacture multiple different types of products for multiple companies. Each new product brings a new learning, be it a new technology or a new and improved method of processing. We work with the best in class across the biopharmaceutical industry which allows us to become best in class as a CRDMO.


What are you working on at present?


We have completed the commissioning and qualification phase of the project and have moved into the manufacturing of engineering batches. Engineering batches allow us to test our recipes and procedures prior to the manufacture of product for human use. We have successfully completed the first of our batches and are making improvements and tweaks to ensure successful qualification during our validation batches. We have a very aggressive production schedule to meet, so my team need to ensure that we manufacture right first time and aim for 100% success rate during manufacturing. We need to challenge automation recipes, process recipes and procedures to ensure they are robust enough to allow us to control process parameters that are critical for successful batch manufacture.


The production facilities within WuXi Biologics offer flexible high tech equipment that allow us to turn over batches at a fast rate. We predominantly use single use technology within the manufacturing facility which requires a lot of design and testing prior to use. My team work with vendors to ensure we only introduce single use technology that meets pharma grade specification and is robust enough to meet our needs.


In addition to the demands of the current batch schedule we also work on new product introductions with both new and existing clients. We determine if their product will fit within the current manufacturing suites. We work on facility re-design to accommodate where possible, new equipment design, purchase, commissioning and qualification while supporting the Technology Transfer of the product into site.


No two days are the same in WuXi Biologics which means it never gets boring.


What is the best part of your job?


I have the pleasure of leading a fantastic team of scientists and engineers. Gender balance within the team is 50-50 and we have a great mix of nationalities which always makes lunch time interesting as we discuss different traditions, cultures and of course food.


There is a mix of experience within the team from university interns to people with 15+ years of experience. The team are extremely dedicated to the products and are focused on the manufacture of high quality, high yielding batches. The team are also focused on improvements, they research new technologies and bring new ideas on a continuous basis. They analyze manufacturing times/time in plant and drive down production costs where possible. Overall the team are responsible for batch manufacture, meeting critical process parameters and ensuring the batch is viable through automation recipes, batch documentation, processes and procedures. Seeing the successful manufacture of a batch and knowing my team are largely responsible for that success through processes and procedures they have created is probably the best achievement overall and the best part of the job.


Their determination and drive for success makes my role a lot easier than it should be.


What is a defining career moment or high point for you? / Is there a career moment you are really proud of?


The day/night we completed our first drug product fill within manufacturing will forever be one of the high points for me. I joined WuXi Biologics at a very early phase of the project. During the interview stage my manager Ronan Rafferty took me to see the site where excavation work had just begun. Seeing the site manifest from the construction phase and mature into an industrial complex has been exciting and eye opening. Being involved in the design, construction, commissioning and qualification phases give you a different insight into the workings of the facility. The opportunity to be heavily involved from the very start, to the day we filled the first ever bottles with product, was a massive achievement and will always be a career moment that I am really proud of.


In addition, we came through a start-up phase of the project in the height of the Covid -19 pandemic. We put every precautionary measure in place to ensure people felt safe and could close out the construction phase of the project. There was a huge commitment from everyone working onsite and at home to ensure the project continued and that key milestones were reached for site.


Where do you see WuXi Biologics five years from now?


I expect WuXi Biologics to be busting at the seams with multiple products and focusing on expansion into adjacent overflow land five years from now.


What’s the best piece of professional advice you’ve received at WuXi Biologics?


When I joined WuXi Biologics we were receiving applications from hundreds of people. There was pressure to fill roles, yet it was very hard to decide if people would be a good fit for the team. One of my colleagues advised me to wait for the right person to come through instead of filling a role for the sake of it. This has been the best advice I have received and the reason I have such a fantastic team with a huge skillset of people.


If you could go back in time and give yourself a piece of advice at the start of your career, what would that be?


To ask more questions and to become more involved in cross functional teams. You only get a true understanding for an organization as a whole when you get stuck into their processes and procedures. If you don’t understand why or how something is done the way it is, ask why. It will give you a better understanding of the facility as a whole. You won’t learn if you don’t ask questions!


What advice would you give to someone who is thinking about interviewing at WuXi Biologics?


I would suggest you research the role and make sure it is the role for you. Biopharmaceutical manufacturing does not mean you need a qualification in science or engineering. There are many roles to suit many professions and for those just starting out with qualifications and without. We need you to be mindful of what we do and the importance of supply of high quality product to patients in need. I would suggest you follow our promotional material look at our PROUD values and decide if you want to be part of our team. Learn how WuXi Biologics interacts and gives back to the wider community and local charities. Research our sports and social clubs and societies and see if they interest you. Finally look at location, commute and lack of morning and evening traffic.


What would you say are the key skills and capabilities necessary to be good at what you do?


When you move into a leadership role it’s important that you allow your team make the decisions and you become the sounding block. I am ultimately responsible for the decisions my team make so it is important to hear all suggestions but guide the decisions based on experience. Every person has a different view or suggestion, no one person can always be right so it’s important that everyone is heard, given a chance and that we try new methods.


What is the best career lesson you have learned so far?


· Be open minded to new ideas and suggestions and embrace change

· Don’t be afraid to challenge. If you don’t think it’s right or if you think something could be improved then don’t be afraid to say. It shows you care and have quality and responsibility at the forefront of your mind.

· Be seen and be heard. A quiet child is always last to be fed! If you want something to happen you need to be vocal. Say it and follow up!


If you were applying for role today at WuXi Biologics, how would you prepare?


I would research WuXi Biologics as a global company. Look at how we work and interact with our clients. I would come armed with multiple examples of how and why you are a fit for the role. Find someone who works in the company, reach out and ask for feedback and come prepared.


Which industry professionals would you recommend people to follow on Twitter/LinkedIn?


Within WuXi Biologics, I love to follow Xiaoyu Xie. She is our PR & GA Lead of Ireland, Corporate Communications and Public Affairs. You can become so submerged in daily activities that it’s hard to keep up with all the activities onsite. Xiaoyu, does a fantastic job publishing and promoting the Dundalk site and the local area.


As a carryover from my previous employment, I like to follow Liz Dooley on LinkedIn. Liz is a Senior Director in The Janssen Pharmaceutical Companies of Johnson & Johnson, leading engineering and technology groups within a best in class plant. Liz puts a huge effort into the promotion of women in Science, Technology, Engineering and Math (WiSTEM) and is heavily involved in ISPE Ireland Affiliate. She is a key speaker at many events and promotes heavily through LinkedIn and social media.


In addition I generally follow sports mentors and coaches as they all use different methods of coaching and mentoring. It can be good to get a completely different perspective on how to manage teams from alternative sources.


Is there a particular book or resource you’d recommend to someone early in their career?


There is no one book that will define your career. There are snippets of wisdom you can take from many books but the only way you can define your career is to get stuck in. Be flexible to business needs. This will allow you to gain experience and build on your current skillset which will set you up for future employment.


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