In today's episode I was joined by Andrew Cieri, Senior Director of Quality for Regeneron's newly acquired cell therapy unit.

Regeneron are launching a new cell therapy unit after the acquisition of the pipeline and commercialisation rights to 2seventy products and Andrew has been tasked with launching this unit! I wanted to talk with Andrew to learn about his journey and how he's gone developing himself - both as a quality professional and leader.

Chapters

• 00:00 Introduction and Background
• 03:58 Early Interest in Science and Technology
• 07:56 Transition from Manufacturing to Quality
• 11:14 Transition into Leadership in Quality
• 22:58 Impact on Product Quality and Reflections
• 28:03 Current Focus and Future Plans
• 34:12 Values for Success in Quality Assurance
• 36:39 Leaving a Legacy and Advice for Future Leaders
• 39:23 Conclusion and Contact Information

Throughout his career, Andrew has been proactive, from transitioning into quality from manufacturing to going back to school to do a Masters in Engineering Management to develop his leadership skills. He's shown self-awareness throughout his career and still to this day is always looking to improve himself as a leader.

Thank you for joining us, Andrew, and looking forward to seeing all the amazing work you and your team do for patients in the future.

Andrew, welcome to Let's Talk Quality, the podcast season two. Great to have you on the show. Looking forward to our chat. I've given you a bit of an introduction, but if you could give the listeners just a high level introduction of who you are and your role and we can go from there.

Yeah, thank you so much for having me. Very excited to go through this. I did hear some of your season one podcast, so I'm excited to participate. My name is Andrew Cieri. I am head of quality for a newly formed Regeneron cell medicines unit. Regeneron recently acquired the pipeline and commercialization rights to 270 products. And so we are launching a new unit within Regeneron.

Excellent. Exciting stuff. So we're going to get all into that. I really want to just explore your, I suppose, your journey in quality. You've had an interesting journey, I suppose, and gone into leadership positions in the last sort of six, seven, seven years or so. But let's go back to the beginning. Why did you get into science, I suppose, and then what's continued to...

keep you in science and inspire you through to this point.

I I've always been interested in technology and how things work from a young age. you can imagine, I guess I grew up in the eighties. I guess I'm aging myself. but when I was younger, my mother likes to tell the story that I took apart every piece of, technology that we had in the house. So that includes like AM FM radios, phones, analog and, dial up.

anything I could get a screwdriver to when I was younger, I was taking apart. Remote controls, which are just coming out at the time. So you can imagine the frustration that my parents had. And that curiosity just continued all the way through school. I always was kind of drawn toward science through all the way through high school. And when I came to make a choice in majoring in college and choosing a college,

I ended up choosing WPI, which is Worcester Polytechnical Institute, and majoring in chemical engineering. I ended up majoring in chemical engineering because I was, I preferred, I liked chemistry the most out of all the sciences, and that was the field which would have given me the broadest upon graduating, kind of the broadest access to different industries. So by the time I...

Ended up graduating. I chose the biotech field and continued on. I'm from Boston and Boston has a huge kind of ecosystem for biotech and pharmaceutical development. So plenty of opportunities here. And that's where I continued. And right now, what inspires me now is just everything that's happening now in biotech continues to be incredible.

Like we are at a point in time where precision medicine is actually becoming marketed to patients worldwide. We're at the very beginning of that, but it's gonna be quite the journey. And these medicines and therapeutics are indeed precision and do work. But I think there's a lot of work to get them safer and have increased quality and reducing risk to them. So I think we have a.

a long road ahead. And that's what really excites me, being in this field and seeing all of the awesome science and innovation that is happening and doing my little part to bring it to patients.

So you did your chemical engineering degree and then you went into your first role was you started off in sort of more manufacturing validation space, didn't you?

Yeah, so yeah, the beginning of my career was definitely focused on validation and process engineering and really in biologics. So I essentially, by the time I was done with validation and moving on, I had touched pretty much every single piece of equipment that is needed for biologics manufacturing. So that comes that's inclusive of all the facilities, utilities and instruments.

and actually all the processing equipment. So I gained a very good understanding of what it takes to manufacture biologics throughout that initial part of my career.

Yeah. Yeah. And then how did that transition from manufacturing into quality go? And why? Because it's like one of the themes from a lot of the conversations that you have is people don't generally choose to go into quality assurance from, you know, as it from a young age, it's something that you typically can fall into, depending on the route you take. So how did that transition occur?

I do like to say I kind of woke up in quality one day. It kind of feels that way looking back sometimes, but I think I did have a little bit of a journey and some guidance on the way. As soon as I came out of college, well, during college, I interned at the company, UMass Biolabs that ended up hiring me. I was actually initially in a quality kind of compliance group, but quickly moved onto the floor.

to kind of get my technical chops. And the two leaders in that group that I was most closely with and working in a trailer with had a lot of experience in quality. And they helped me, kind of mentored me to make sure that I went out and got my technical experience. And if one day I wanted to come back into quality, there's always that opportunity. And it ended up happening kind of organically. So when I was in...

the role before getting into quality, it was a very quality and compliance task heavy role in manufacturing. So it was a manufacturing specialist group and I ended up being the supervisor of some other specialists and we were very focused on lab and manufacturing investigations and writing all those up. So there was a lot of technical writing involved and then as a supervisor of that group, I ended up.

doing a lot of reviewing and approval of the technical writing and then ended up training newcomers into the group and into the facility in technical writing. So kind of got sucked into a lot of those tasks are very similar to the quality group. So many times there is a SME.

or manager review prior to getting to quality. So I worked very, very closely with quality before moving into quality. And I got to know the folks, I guess, on the quality team. And it was satisfying, it was intriguing. I liked doing that work. So when there was an opportunity to get a manager role within quality, I applied and was selected. But.

A lot of the work I was doing was definitely day to day working, working very closely with quality. So I had a good understanding of, of what I was getting into. And a lot of the work translated. Of course, there was a transition that happened after that. And I think I'm glad that I did work with quality very closely and did perform a lot of the tasks, but that was definitely not everything that was there. I'm glad that I got a little bit of a leg up, but.

Yeah.

Yeah.

Definitely had a transition after after getting the quality

So was that Sanofi that were your first role in quality? Yeah.

Yeah, so I had a run in corporate validation at Santa Fe, then a role within manufacturing, and then moved into quality, all within Santa Fe, all within the Framingham, Massachusetts campus, which had multiple products, multiple commercial products being manufactured.

Yeah. Do you think working in that environment or large pharma environment helped transition because obviously there's, you know, qualities, there's a lot of products, a lot of commercial products, manufacturing going on and manufacturing and quality have to work close, you know, side by side, I guess. Do you think that probably helped you in that transition because you were, you know, almost working so closely to one another?

Yeah, I think it definitely helped. And I think at the time, the level of maturity of the quality system and the quality team that was needed to support commercial really put a lot of the responsibility and a lot of the tasks on the supporting groups. So on manufacturing, on the testing groups. And we actually had to take on a lot of those tasks and improve the quality of our work.

Yeah.

within the actual team. So working closely with quality to take the ownership of all of the documentation and all the work that we were doing was very helpful and eventually moving into quality. So I got to understand a lot of the operational excellence that goes on at a commercial site like that. A lot of how to improve right first time of documentation, of manufacturing.

Yeah.

how to improve quality of the product, how it's all connected, coming back from the testing and the supply chain and improving that manufacturing line to increase yield, reduce costs across the board. So quality is so involved in all of those activities and we had a good group there.

and it's definitely needed to support commercial manufacturing. So getting the products out the door and out to patients were paramount. So being in that environment was very rewarding and it was a great experience.

So then from Sanofi, you went to Alchemy's and then obviously you're in an associate director role and then transitioned into a director role at Bluebird further down the line. So let's talk about that transition into leadership and quality leadership. It's an interesting one. A lot of people will just naturally want to go into a leadership position. Some people may fall into it. Some people want to carry on as an individual contributor. I suppose, why did...

Why did you want to, did you want to progress into leadership position? And if so, why? And then, and what were some of the, I guess, challenges that you faced at in that initial transition into leadership?

Yeah, so kind of a two part, two part or three part question, I guess, initial, initially getting into, into leadership was not within quality and then kind of the growth within quality and the leadership there. So I guess initially I, I enjoyed the part of our, of my job and my experience that entailed coaching and mentoring others.

and teaching others and that was probably inherent to my personality and my experience even outside of work. I've always been involved in multiple sports. That was a very big part of my life for a long time. So eventually also moved into coaching of sports. So it was kind of like a parallel path in my life moving into leadership and finding satisfaction there.

And that is a key point is it's finding satisfaction in leading people is definitely a choice that you have to make. And initially it's something that you have to try out and see that, see if you actually like it. And there was a period initially where, yeah, I knew I liked it. I realized that I realized that wasn't good that great at it, to be honest. And I had to improve. There was so much of that aspect of work.

the day -to -day work that I hadn't prepared myself for fully. So I decided to go back to school and get my master's and decided to get a master's in engineering management from Tufts. And that was a big kind of turning point in my leadership. And I was able to apply a lot of the learnings from that program into what at the time I had already transitioned into quality.

So I was able to kind of, I guess, amplify and improve my leadership within quality due to the fact that I had gone to school and improved and really self -reflected on myself and my role in leadership and what I could do to improve within, not just within quality, but within the organization that I was in. So that was a kind of a definite active choice.

that I made and it's still to this day is probably the most satisfying piece of my day to day. It is coaching, it is mentoring, it is helping others in their career. That is a big piece that brings me satisfaction on a day to day level. But it's a continual choice and it is a huge aspect of the job that you have to improve on in order to get results. So.

You have to continue to whoever is, if anybody out there is thinking about getting into a leadership position, obviously try it out first, see if you like it. And it is definitely an additional challenge to your career that you have to continually improve on.

What was it that you, was there anything that triggered you thinking, right, I need to go back to school and get my masters and really develop my leadership skill? Because it sounds more like a technical skill set. You know, you've got the, the, I suppose the softer skills maybe that you that you had going into it, but it sounded like to balance the two or merge the two together. Was there anything that triggered that?

It was almost opposite. I think I had the technical skills at that point. I was highly technical the first 10 years of my career, coming out of college, being day to day, working with equipment, and then translating that. I never really fully translated that, I guess, love of coaching, love of teamwork into my actual day to day work day. So at work I had...

Thanks, guys.

plenty of technical chops, but I realized I needed to improve on those people skills and people management skills pretty quickly. I wanted to improve because I wanted the team to improve and I realized self -reflecting that I needed to understand that piece of it more, which I hadn't really studied or took the time to. Of course, in coaching sports, there are a lot of parallels, but it's not the same.

Yeah.

than coaching professionals. So I hadn't made that connection and I needed to and I wanted to. So that's really what kind of drove me there.

Let's talk about that then. What are those traits you think are transferable and that you have to bring in and other leaders should be bringing into their leadership within a quality realm?

Yeah, so given and receiving feedback, huge. And especially in quality. Sometimes, well most of the time in quality, you're actually seeing the output of your counterparts work, day to day work, sometimes even more than their managers. You're seeing all the documents that they're producing, you're seeing all the executed work that they're actually producing, and you in quality.

are there to review and approve. And also there is an aspect of coaching and mentoring there if there are things that do need to change and are needed to edit. And that is an aspect of a quality professional, whether you have reports in a team or you're having to influence without authority or not, just being used to giving and receiving feedback and improving is an important aspect and something that.

is critical both from a leadership perspective and from a quality professional perspective.

Yeah, absolutely. It's, it's so important. This just sounds like you're very self aware. And you've always been that you've always had that self awareness throughout your career, the fact that you identified key learns and triggers that, you know, you may went back to school and learned that and I think that's a big part of any leader is having that ability to look inside and, and really work on your own skills and be honest with what where you need to develop.

Sounds like you've always had that trait growing up.

Yeah, and definitely I've been lucky to have positive influences in my life from my family to my coworkers. My wife currently is also in the industry, so I have that feedback as well. And she's an awesome quality professional. So both outside of work and inside of work, I've been lucky to kind of...

interact with a lot of other leaders, both in quality and outside of quality and learn from them and get their feedback and be open to the feedback, which is something that I think at the beginning of the career, I didn't even realize. I don't even think I was realizing that I was getting mentoring and feedback. And there was a switch that happened at one point where I'm like, okay, now I'm now is actively seeking it and actually inaction in it throughout throughout the day to day.

Yeah.

Yeah, yeah, yeah, excellent. That sounds like you've that obviously learning that and going back to school is obviously quite an important part in your career. Are there any other parts of your career which you look back and think, well, that was a pretty big moment for me and a pivotal time for my career?

Yeah, I would say going back to school was huge. I really opened my eyes to the industry as a whole, but also how it connects to all of the businesses that are out there. So within my cohort, we were interacting with folks from different industries. It was tough. It was in Boston. There was a large percentage of biotech.

professionals there, but we also had folks from companies like Raytheon, in the defense sector, we had other, especially computer science background individuals in the cohort, automation, all that sort of technical kind of, the technical hotbed that we have here in Massachusetts was kind of reflected in that cohort and I was able to learn there.

Another big, and it opened up my eyes to just reflecting upon my own career, my own journey, where I fit, where my company was fitting in the overall kind of landscape. The other big change that I think I consciously made was moving more from commercial focused biotech into the R &D side and kind of expanding across.

outside of just GMP into the GCP, GLP world. And that was very eye -opening to me to see that whole other aspect of product development that I had been largely exposed to. There were little bits and pieces throughout my career where we were working on clinical trial material, but largely the work was focused on.

on commercial and supporting commercial. So that move really happened when I moved into Alkermes and coming with that, I also interacted a lot and had responsibility for the external manufacturing quality, which was much, much different than when I was used to being internally focused and having kind of the manufacturing line, all the equipment next door.

Yeah.

able to go and see, go to GEMBA per se and see what was happening and have an understanding. Whereas now you're dealing with a CMO or a CTO and you don't have direct line of sight into what's happening on a day to day. And you still have to somehow influence and build a relationship so that you're able to make quality decisions on something that is two or three steps removed from your direct line of sight. So that was.

Yeah.

Yeah.

The combination of those two kind of scopes and kind of spans of responsibility for me was definitely a turning point and eye -opening and was a great experience.

Yeah.

Brilliant. Let's just touch on, I think we've got a touch on your time at Bluebird and 270 and obviously now in to Regeneron, you've obviously been through a very, an incredible journey during that time and had a big impact on product quality there. When you look back at the last few years, how do you see it and what things will you remember?

when you really take a look back at your career in years time.

Yeah, so the other conscious move I made was definitely to get closer to newer technology. So biologics was also a focus of my work at Alkermes and moving from Alkermes to Bluebird was moving from into a different technology. It's cell and gene therapy. So definitely at the forefront of

of innovation and a lot of what's coming out of the Boston area is in that kind of genomic revolution that is happening right now. That was eye opening. We had one of the first cell and gene products being commercialized in partnership with BMS that was a Beckma and simultaneously we had a pipeline very close to commercialization and all the way through preclinical and clinical.

My focus initially coming into Bluebird was on one product, Skysona. I was a quality product lead for that. And I was able to kind of cut across the, not only the supply chain, but the entire phase that that product was in, just right pre -commercial, being commercialized in Europe and getting ready to be commercialized in the U .S. and all of the quality activities that were,

involved in that. Kind of able as a quality product lead, I didn't have direct reports, but I was interacting internally and externally with the CMC teams, with the regulatory teams, with the clinical teams as we were preparing for launch essentially. So that was very eye opening for me. I got a lot of experience there. And...

At that time, COVID also happened. So what I learned from that was that we are living in an ever increasing, you know, what they call a VUCA. We're in a volatile, uncertain, ever changing, and ambiguous world. And you have to be able to adapt and deal with that on a day to day.

you

And there are skills that come along with that as well that you have to develop in order to be part of that innovation curve and to support and anticipate from a quality perspective everything that's coming and that's needed to push the products along the product development life cycle.

You generally learn the most or you learn a lot in those times of challenging and adversity and volatility. What do you think the biggest learns have been in your leadership journey in quality assurance?

That being adaptable to change, change is inevitable. So since 2020, joining Bluebird, not only did we split in 2021, the company split into a commercial focused oncology focused company in 270 and Bluebird retained the SGD, the Cerviagenetic Disease products and ended up commercializing those.

ability to adapt the change to quickly assess and plan and prioritize, to try things out and don't be afraid, not being afraid to kind of try things out and fail and then readjust quickly and do that constant kind of planning and prioritization and execution and just trying to see what fits and what doesn't. And executing on a shared vision. So doing that,

doing that work as a team on aligning on what is the vision right now so that we're all marching towards the same vision even though many changes are happening. We have kind of the eye on the ball and can kind of adapt to everything that's happening on the ground.

Yeah.

Awesome. So what's, when we're coming towards the end of the show, and I've got some quick fire questions that I want to ask, but before we get into that, where are you at now in your career and like, what's next for you?

What's next? So I'm a big believer in executing on everything that is in front of you right now. So I'm very focused on on my quality leadership team. I have a very talented quality leadership team and a new quality unit that has been formed out of the Regeneron acquisition. And we are focused on establishing that mission right now.

We have focused on executing on all of our preclinical and clinical manufacturing and getting those products through the product life cycle. And as a quality team, just ensuring that we're establishing that patient -centric quality culture to enable that accelerated kind of product development. So anticipating.

what the needs of the business are from a quality perspective is very important. We work on being aligned internally, so doing that extra communication internally so that when questions inevitably come from the business across different units, we're all aligned. And just being accountable and doing that exercise of planning.

experimenting and committing and reprioritizing and ensuring that we're hitting all our goals. So just very focused on launching the regeneron cell medicines right now. And I'm a big believer in if you do excellent work on what you're responsible for, opportunities will eventually come and you'll be ready to take advantage of that. So that's, I don't really have, I guess a great answer for what's next.

What's next is just getting insured and insured I'm ready for the next step. That's all.

I think, I think that's, well, that's it. I think you've got it. Like you say, opportunities come when you, when you execute and you do a good job and you know, that's, you can only do what the tasks, what tasks are in front of you. And that, that means executing. What, just one thing on that patron, patient centricity topic, like are there any practical things that you, your team do that you've done in the past or you advise to, to drive that and sort of almost bridged the

the gap between the biotech and patients. Are there any practical things from a leader that you would advise?

So patient centricity is, you know, I think to us in biotech, our patient is our customer. I think what you can start with is from a quality perspective, we in quality are usually a service oriented piece of the puzzle. So we need to be very customer focused in the first place. So you start with who are your customers?

immediately within the company and ensuring that you understand their needs and you do the work of understanding all of your customers needs within the company. And then when it comes to executing on that, you will inherently have the patient in mind for everything. And in selling gene, in particular, giving that it's personalized medicine.

That is the one thing that I think was maybe, I would say, easier to understand and have as a fabric of the day -to -day, as opposed to maybe large -scale biologics manufacturing, where you're manufacturing thousands and thousands of doses for patients that are maybe months away. Cell and Gene Therapy, you are focused on...

that one participant in the clinical trial or that one patient commercially. And there is a very, very easy tie to make to the current work that you're doing to that patient on the other end. And we are in oncology in this unit. So obviously easy to relate. Personally, everybody's been touched by cancer, obviously. So there is a...

moment that we take as leaders as well as workers in this industry in that reflection that you're really working with folks and working for folks in their families and support units that are battling cancer and that's a huge battle. And so we should be doing everything we can beyond the day to day to support that. So,

That message, I think, a little bit easier in the, maybe in the cell and gene oncology space, and we kind of do that on a day -to -day reflection, week -to -week.

But that is something that is central to what we do. And it's something central to me, and it's something we always try to ensure that we have patient moments. And I encourage my teams to always participate that at large when the company is facilitating that, but also to personally think of, it's easy to think about anybody, most of us have been probably touched by cancer in particular, but any.

any disease. And this is very, it's pretty easy to kind of make that leap and make sure that we're keeping the patient in mind.

Brilliant. Right, we've come to the quickfire rounds. A few quickfire questions to throw at you, Andrew. What are the three most important values that you live and die by?

so I would say the three things that I'm always, that's always top of mind for me on my day to day, as a leader and as a leader in quality is teamwork, efficiency and compliance. So at any given moment, all of us are part of teams. There is a reason why we're in those teams. we should be contributing to those teams and taking a moment to reflect on what your.

Role is within the team, but also on how that team is doing What can you do to improve any team that you're working on on a day to day? That's only going to help Ultimately the quality of the product but also the the quality of the day to day when it comes to efficiency What are we what what are you doing in? The business process and in the day to day from a from a quality perspective of course there's a lot of quality management systems out there and policies and procedures and

work that we do on a day to day, what are you doing to implement more efficiency in your day to day work? So we should all be able to take accountability from a leadership level all the way down to individual contributor level. What can I do to ensure that we're being more efficient and be the leader, take initiative to...

ensure that you're being more efficient. Bring up inefficiencies and then, you know, volunteer to tackle them. It's not easy to do, but it's something that is so important to really move the needle in terms of quality and on the day to day. And then being in quality compliance is important. So how are you, how are my, and how is the team navigating the complexities that come with ensuring we are,

remain compliant with all the regulations, whether it's worldwide or in the US and the FDA, and making sure that the teams are at least aware of the minimum requirements at any given moment, and making sure that we're reducing compliance risk along the way. So those are like the three areas. It's teamwork, it's efficiency, and it's compliance. When it comes to quality and quality management, those are the three things that I value the most.

Do you believe in leaving a legacy?

So yeah, I think so. I think personally, again, I go back to growing up in Boston and being in a hotbed of biotech. And there is a ton of research and development that is getting pushed out of this area. So I want to contribute to that. I don't intend on leaving the area. I intend on staying here and rolling up my sleeves and doing that work that is in front of us. And...

Helping patients throughout the way and getting innovative therapies to market. As many therapies that I can help do my small piece to push forward. I think that's important. And I think that is definitely part of what I would look back as my legacy.

Excellent. Final question. What one piece of advice would you give to future quality assurance leaders?

I would say definitely when I'm looking for hiring into my group, especially I am looking for folks that can deal with that constant change, dealing with complexity, dealing with the volatility and the uncertainty. So that means you have to be adaptable to change. That means you have to be able to quickly assess a situation and plan and prioritize.

be able to break problems into chunks and execute and not be afraid to take a risk in experimenting with a solution only to potentially fall on your face and have to restart. You have to be able to do that in order to keep up with all the change and the volatility that's happening. That's the only way.

You have to break down the complexity. You have to make things, make as much certain that you can on your day to day in order to execute and keep up with that. So that's what I would be looking for, individuals who have that kind of propensity to deal with that environment.

Awesome. Excuse me, Andrew, it's been a really enjoyed the conversation. Thank you so much for coming on the show and thanks for giving us your time. If people would like to get hold of you or contact you is LinkedIn generally the best way.

Yeah, absolutely. LinkedIn is the easiest way, for sure.

Okay, awesome. Well, I've really enjoyed the conversation. Thanks again, Andrew. Best of luck with the role with Regeneron and all that you're doing. And we'll have to have another conversation, another podcast in a year's time to see how everything is developing.

Absolutely, thanks so much, Hermitian. Good luck with all the rest of the season.

Thanks, Andrew. Speak soon.

All right.