LabOps Leadership_Omri Paran: Audio automatically transcribed by Sonix

LabOps Leadership_Omri Paran: this mp3 audio file was automatically transcribed by Sonix with the best speech-to-text algorithms. This transcript may contain errors.

Kerri Anderson:
By building a platform to share challenges, thoughts from leaders, and network together, the LabOps Leadership Podcast is elevating LabOps professionals as well as the industry as a whole.

Samantha Black:
With the intent of unlocking the power of LabOps, we deliver unique insights to execute the mission at hand, to standardize LabOps, and empower LabOps leaders.

Kerri Anderson:
I’m Kerri Anderson.

Samantha Black:
And I’m Samantha Black. Welcome to the LabOps Leadership Podcast.

Samantha Black:
We are here today with Omri Paran, who is Senior Director of Operations and Practice Leader at Azzur Cleanrooms on Demand. Thanks for joining us today, Omri.

Omri Paran:
Thanks for having me, it’s my pleasure.

Samantha Black:
Great, so let’s jump right in. First question is usually about background. So can you just tell us a little bit about how you got to where you are today?

Omri Paran:
Sure, from my education, I’m a mechanical engineer, and joined my first life science company, it was called Pacira Pharmaceuticals as an intern just before graduation, it’s this perfect intersection of luck and me looking for opportunities. So at that time when I was hired, they were still, all their products were still pre-commercial, so they’re all late-stage developmental, and right when I joined, it was on the tail end of some bad news from a clinical trial. So the company had gone through significant layoffs, I think 40% layoffs, and with my hiring in that cohort, they were rebuilding again. They recruited new funding, and we were rebuilding. So the company was small, it was about 60 employees. The mission at that point was to commercialize their first product. So it was all hands on deck trying to get this product kind of into the end zone and commercialized. And so even as an intern in their engineering group, I got a lot of opportunities to learn the ropes of how operations in pharmaceuticals actually runs. So my title was CAD Intern, just controlled all the drawings and revise drawings. And so in this role early on, my responsibility was to walk down the equipment that was being built like the actual, we called them skids. The skids were all of our stainless tanks, the valves, the pumps, everything that’s responsible for manufacturing product. So I’d walk down the equipment and then make sure that the drawings aligned. So it was, so at a very granular level, I understood what the equipment was that was charged with manufacturing the product. And so with that experience, I kind of started to connect to other departments. And that’s the first experience I had where I started to pull information from different groups and then became a concentration group of information that other departments depended on to understand what’s happening on the floor. I started to learn about calibration and started to learn about the data output that was coming out of this skid. So these, this manufacturing process was highly skills, a lot of data collected, if you think about temperature probes, pressure, probes, conductivity, mixer speeds, pump speeds, valve states. So there’s a big data set that represents the progress of every batch. And if you imagine we’re developmental, we’re still trying to find the secret sauce, if you will. And so small variations batch-to-batch wants to be understood, need to be understood, or hard to understand. That’s what is the controlling step for progress, that’s what I observed, at least at this stage of the company’s maturity. So it came a critical piece that I could contribute, after I learned how to read these data traces from the automation was, I could take this data and then share it with the R&D leaders and the operations leaders who were using this analysis to determine how they should tweak the recipe to make the next batch more successful and closer to the endpoints they wanted to see. So I started to incorporate this knowledge of how to get the data out, how to relate that, to how the instrumentation actually works out on the floor, and so that kind of got me in front of decision-makers who were actually deciding how to vary parameters to achieve the endpoints they need. A year passes, and they have an opening in their automation engineering department. At this point, I’ve also graduated, so I applied for this role in automation engineering and which kind of aligns really well with my background in mechanical engineering, and get that role. And then a short year after that, the company is successful, we commercialize this product, and we transform one of our research and development suites in San Diego into a commercial suite. So there’s the level of compliance goes up a little bit when you’re commercializing. I was then, my role then was to continue overseeing the automation system and these data streams from production and to make sure that all the ends are tied up between the data that’s gathered on the floor and what ends up being recorded in our batch record and what kind of goes along with substantiating the quality of every single batch we make. So also, of course, you can, when you transition from R&D to commercialization, it’s we call that a tech transfer, a technology transfer. And physically what’s happening at a company level is that the folks who are operating the equipment, they’re actually changing in the prior stages, like in clinical development, and in those early stages, a lot of R&D folks are involved on the floor. They’re watching the equipment, they’re watching real-time data, sort of free to make little tweaks, to keep the process going. And when you transition into commercial, those people are gone, and the folks running the equipment are manufacturing technicians who, you know, they don’t possess the institutional knowledge of, exactly, oh, this doesn’t sound right, let me tweak something, or let me report something to supervisor because this doesn’t seem right. You trade this institutional knowledge and who’s running the equipment, but you gain a lot of consistency. That’s what having manufacturing technicians affords you, is that there’s a much better guarantee that batch to batch it’ll be run consistently. So what that also means is that if there’s a built-in issue in the way he’s running, that issue will appear again and again every lot because this was a young commercial system, it was sort of riddled with bugs, if you will. And some of them were software bugs, which were in my area to fix. So we called this, we had a big blitz where we had to repair these software bugs, so that was in my responsibility. And so I was learning what sorts of issues appear when you’re commercial and then what are the corrective actions that are appropriate. So I implemented them, and at the same time, because it’s a new commercial system, our cycle time was quite slow. So you can imagine cost of goods is quite high and cycle times slow. So coupled with the mission to remove the software bugs was also this sort of concurrent mission to over time reduce cycle time significantly and try to get lots to fit within a 24-hour period so that the company could bring production to a 24/7. So that took several years, but we, but when we launched commercially, we were producing about maybe less than five successful lots per week that were passing our release criteria. And then when this sort of development cycle time reduction and the blitz to reduce bug was basically much more mature, this same production facility was producing lots, so the whole company had to, the culture in parallel with my development and my learning, the company culture was evolving. We staffed up from 60 employees when I started up to over 25 at this hub that manufactured in San Diego. We transformed the culture from being very centered around development, R&D tweaking, we evolved and moved to a much more consistent, regimented, even you might say, sort of production facility. And so running much more consistently, finding alternate suppliers. We did everything we had to do to make production more consistent and more reliable, and that was success. And fortunately, sales also of this product picked up, and it was time to scale up production. The company was looking at ways that it could guarantee the stability of the supply and kind of risk mitigate against having one single production facility in San Diego. So what the company decided to do is to contract with the CDMO in the end to augment production. So they decided to retain their own run production facility in San Diego and bring up this partner in the UK. And they noticed over time that my character is such that I like to work with lots of groups. That’s what helped me be successful early on as I was collecting information from different groups, sharing it, the different groups. I was …, I like being in the position where I’m a central person that people can depend on and go to, and I like to learn from lots of people too. My career gets dull if I’m not learning things that rub off on me from other folks. So because of my, because I’m inclined this way, they asked me to go to the UK with another engineer and lead the tech transfer effort to do this. And so when I reflect back on that opportunity, it actually was one of the high points of my career until now. We, so my family and I relocated to the UK, and we lived there for one year while we, while this UK partner of ours was beginning to start up their own the same skid. It’s this twin skid of what we had in San Diego. We started about in the UK, and so, of course, we had to teach them the technology, and my role was to teach them how to manage the automation piece, how to have their, how to get their arms around all the documentation. They have to use to, all the specs they use to control how the automation is actually developed. And then we also had to teach them, we had to transfer all this tribal knowledge that may or may not appear in documentation and explain, when you run this equipment, you should expect these issues. If they pop up, here’s a library of corrective actions and then we hand it over. And then and then when one year was up, we went back home and then we support them remotely. So it was very interesting to observe what sorts of issues appear on, when these other companies running our same equipment, on our same recipe. Interestingly, a lot of these are the same, but some issues are unique, and it just comes from the way they approach doing certain activities. So it would have this other company run the equipment and our product, actually gave us information, and it gave, it shed new light on our own process. So observing deviations that they experienced at their facility helped us discover preemptive improvements we could implement back in San Diego on the original facility. And now we’re roughly at 2016, and so we’re commercially manufacturing in San Diego and in the UK, and now as an initiative to implement continuous improvements and to continue reducing the cost of goods, it’s time to scale up the process again. So the process is scaled up, new equipment is designed, and again, I don’t think I shared this part, but the company culture at … was they really wanted to own every piece of the process, not just the manufacturing, even the design of the equipment. So yes, we hired engineering firms to help, but the in-house engineers were the ones that primarily developed the design of these systems. So we had experts in hardware who actually identified what sorts of tank geometries and impellers we need in our mixers, what sorts of valves we need, and then they had my team and myself, and we actually defined the software recipe and the software steps. So this really strong in-house team made a lot of decisions on how to build a scaled-up system. And so it’s constructed, and then the first scale-up system, it’s about four and a half times larger in, per batch than the original one. The first one is both in the UK with our CDMO, and then the second one is built back in San Diego. So the capacity to manufacture this product is augmented almost 10x in about four years. And so that equipment is running at that time and it’s being started up, still not commercially yet, still under development scale-up process. And I get this bug like I want to, I want to develop in a different direction away from automation, engineering, more toward people management, get close to, and so move forward in that sense, develop new personal management skills, but also move my involvement with the life science process earlier in the life cycle of products. So I wanted to kind of work in clinical manufacturing because then I can work with techs who are on the floor, or getting the manufacturing done, and I could be, and R&D, could be my client, because the new pipeline candidates that are developing, they need to run them on equipment that’s capable of clinical phase production. So it’s equipment that’s bigger than lab scale, … commercial scale. And so I look for this new role, and I find it in my company, and I apply for the job, and I get that. And so in this role, in the Senior Manager of Production for Clinical Production and I’m also, it’s a hybrid role, the other half is I’m also the Manufacturing Technical Support Senior Manager. And so in this role, I have … two roles. One is that I support our commercial manufacturing, investigate quality issues for them, and that’s for the manufacturing type of support role. And the second role is that I lead the team that’s doing clinical production and I get to work with R&D every day and kind of learn how their pipeline is evolving. And so in that role is when I really gain these leadership skills in people management. Prior to that, the leadership I had came from technical expertise, and like I said, people would come to me for data, and so my leadership evolved at this time. I’ve learned how to relate to all different folks and learn what’s important to the R&D department and what sorts of results they need to have, and how we can help them from a lab management perspective, managing this clinical facility for them and getting the loss out the door, and so that was also a great experience. In that role, I reported to a great mentor, Dan Copeland, and so I learned data analysis from him. I learned how to have a really kind of level head from him too, and that’s, I’m very thankful. And then at this point, I had been at Pacira for about 13 years, and it was an experience I would never give back, it was amazing. And so the opportunity came knocking. I heard about this company called Azzur Group, and they had just built a new subsidiary called Cleanrooms on Demand. They, so Azzur Group is a life science consultant, and in 2018 they basically learned from one of their clients, they’re always receptive to client needs, so they learned that one client had a need to build a cleanroom for their clinical process. And so the client was weighing the costs of building their own, they even considered outsourcing production of their clinical activity to a CDMO, and they did a cost-benefit analysis, this client decided they still wanted to build, and this was in Boston, real estate was scarce. It was going to be a tough proposition to build a small clean room. So Azzur decided, we have a warehouse for other activities. Why don’t we build a modular cleanroom in that warehouse? The client will move into our cleanroom to operate their process, we’ll retain their IP, they’ll retain their personnel who know how to run the process. It’ll just be our cleanroom, so we’ll take care of the compliant envelope, if you will, the facility, and this client can focus with their core competence on the chemistry. And so that was successful for the product and successful for Azzur, and so this kind of launched Cleanrooms on Demand. So this business now exists in Boston, there are many cleanrooms leased out there by small companies in large. Moderna is a big client of Cleanrooms on Demand in Boston, and the business wanted to grow, so grew out in the West Coast. It’s, so there’s a Cleanrooms on Demand facility in the San Diego market to tap that biotech hub, and there’s one that I’m launching as this practice leader in the San Francisco. And so it’s the same concept that they brought on with this one client back in 2018. We have this facility in Alameda, and it has 26 cleanrooms, and so multiple tenants can license the cleanrooms, multiple clients can license them. And it’s the same thing described, we take care of the facility like HVAC maintenance, routine sanitization, warehouse, material management, pest control, office space, cafeteria, all the things, all these ancillary costs that a client doesn’t need to carry for them to develop their clinical process, we carry that for them. So again, they can focus their core competence on the chemistry. We have this tagline, we bring the compliance, they bring the science. My facility is under construction now. It’s going to launch, open its doors for clients in Q1 of next year, 2024.

Kerri Anderson:
Wow, that’s an incredible journey to hear how you went from mechanical engineering to where you are today.

Omri Paran:
Yeah, yeah, I know, and I think that’s what I like in my life and my career. I like to learn new things, develop, experience changes, and so this career has taken me around the world literally, and it’s taken me from San Diego to the Bay Area also, and yeah, I wouldn’t give it up for anything in the world.

Samantha Black:
Yeah, you covered a lot. You did a great job. A lot of the questions that I would have asked you, you already answered them preemptively, so I love when that happens, so that was great. But I’m wondering, coming from an engineering background, I think that’s like a main theme of the podcast is, you can come to operations from anywhere. I think you don’t have to have a necessarily science degree to be in lab operations, and I found it so interesting to see how you use that in like your first company. But I’m just wondering why you decided to make the shift where you’re probably not involved in the equipment side of it so much, and more historically where your background is, that seems like a big jump. So maybe can you talk a little bit about why you decided to make that jump? Was it just maybe you liked the people management, and you wanted to do more of that? Or I’m just curious, what motivated you?

Omri Paran:
Yeah, that’s a good question. I have to ask myself that too sometimes. But no, what I didn’t share earlier is that I’m also I’m a closeted finance aficionado, and late in my career, I also got my master’s degree. It’s a hybrid degree called Master of Engineering, and it merges engineering disciplines with some business administration disciplines. And I got that specifically to expand my leadership skills and how to sort of think as a department manager, finance leader for a department too, and so in this new opportunity with Azzur Cleanrooms on Demand. As a practice leader, I’m responsible for the whole P&L for the facility, and it combines responsibilities. So obviously it’s got the oversight responsibility for the facility and all the personnel inside, but it’s also a client facing. So it’s helping me to stay close to what the client needs so we can be responsive to their needs. And personally, that satisfies sort of my interests in learning about people, learning about their issues, trying to bring creative solutions to their issues, and then also this challenge of running the site profitably, trying to render services that are, that will delight the customer while still delivering value to us. So it’s a new challenge, and I always like new challenges, and this kind of helps me continue embarking on this development where now I can focus on my sort of financial discipline, if you will.

Samantha Black:
Yeah, I think that’s fascinating. I think it sounds like you like a hybrid role where you just take on a lot of different types of tasks, and that fits in perfectly with operations because I feel like you have to manage so many different things, so many different relationships with different teams cross-functionally. Sounds like it’s a great fit. I’m sure in your time you’ve come across a lot of different issues, and I think working on the R&D side and then the commercial side, what are some of the main challenges working in an operations space that you notice throughout all of those? Like what are some of the common threads through there that you’ve picked up on and have been able to address?

Omri Paran:
Well, what’s interesting is in automation engineering, we have this troubleshooting method, it’s like a pyramid. If you think of how equipment in the field which is software-driven, how it’s built from the ground up, so there’s a physical layer on the floor that’s like the cables and the instruments, and then you go all the way to the top and then you finally get this presentation layer, which is what’s on the HMI, like what the operator sees. And so in between the physical layer and the presentation layer, there’s everything else, there’s the databases, the computer, the software. And so issues normally, the most common issues are the ones lowest down, so physical layer. And then so that’s like a very simplistic way of identifying issues in automation, but I use that analogy to identify systemic process issues, even human process issues follow a similar pyramid, in my view. So really over and over again failures happen at the most simple physical level, or they happen at the most simple sort of human level. And then when you have a network of humans for that, a better term, but there’s, the numbers of conversations you have to have as a network of humans, it grows exponentially. So it’s like a game of telephone. There’s going to be miscommunication when more people are involved. This goes more than one person is involved, there’s going to be some degree of miscommunication, and you can have success even with 5% miscommunication. But as you have more and more groups, the opportunity for miscommunication grows, and it becomes harder. So what I see in, normally in really critical activities when like tensions are high, if you will, and there’s pressure, and there’s like the time has to be crunched, for example, then people don’t have the time necessarily to communicate clearly. And so this happens at the tech transfer, like when there’s two different company cultures trying to work on one process. This is what we saw in the new, so the first bridge we have to cross is getting a common language, if you will, and so what that means is this issue can be anticipated because it happens everywhere. So having a really well-defined processes that are written down or maintaining dashboards where people can communicate issues and bring to light issues are having on the floor is really helpful. So operations, what we do is we have a daily stand-up meeting, it’s 15 minutes in the morning, and we use a visual management board, and we just write where, we have written down what are the plans for the day, and there’s a … every functional group and what are the activities for the next period, maybe it’s just the next day even. But so every group goes down, and they express to everyone else in the room like, I’m doing this today, tomorrow I’m doing this, I have this obstacle, who can help me get past this obstacle? So it’s just, it’s very frank, and we use language where, you know, I have this issue with the calibration, like it’s a calibrations issue, please help me with this obstacle, you’re the ones that can help me. And so we identify with really clear language what needs to be done to get people’s issues removed so they can move.

Kerri Anderson:
Yeah, that sounds like an incredible way to approach communication within the team, and I think operations, it is a customer service role, and especially at your current company, you’re working with other companies, you really are customer service. What are some tools and ways you have to improve communication with the other companies you’re working with?

Omri Paran:
There’s a preemptive component to that, too, in my view. When we bring a licensee on, and they’re about to move in, then a major piece of the agreement we have to arrive at is a mutual understanding of the services and the swimlanes. So a licensee comes to our facility, we immediately become one of their most prominent suppliers, if you will. This level of service were provided to them is one of the most significant supplier relationships that they’re going to have. It’s us, and they’re critical API, or their tissue supplier it’s, we’re up there. So it’s important to understand a mutual, it’s important to establish mutual understanding of where our services go and where their responsibility begins. So there’s a long, there’s actually a lengthy process of site fit where we make sure that we can induct all their assets and all the raw materials. and at the same time, we’re continually talking about, okay, this is our offering, this is our offering, this is where the offering ends, this is where you can opt-in to enhance the offerings, this is where, and then this is where your responsibility begins. So there’s a preemptive piece where we educate and just say, we arrive mutually at an understanding of what will help us both be successful, the client and Azzur. And then on an ongoing basis, we have touchpoints where we also want to remain abreast of what’s happening in the room. We don’t need to, at a basic level, for us to just render the services, we don’t need to know what’s in the room necessarily because it’s their process, their intellectual property. But if we know a little bit of when they’re getting closer to their milestone, let’s say, and we can understand the human side, that maybe tensions will be higher if they have a failure, they’ll have to regroup quickly, and maybe repeat or run. We can anticipate either they’re going to need like stat test results or stat deliveries of new raw materials. So we like to have touch points and understand what’s happening so we can anticipate, and then we staff appropriately, we can prepare a backup plan, maybe get an extra fridge for them ready if we know there’s going to be extra raw materials, for example. So by doing this kind of pretty, pretty aggressively talking and asking, how’s it going this week? What’s happening next week? Then we can be better partners. And again, we view that as our role. We want them to focus on their chemistry because we want to accelerate their path through clinical development, and we can accomplish that mission by being the ones who take the extra time to check in, because they don’t always have time to, they don’t have time to initiate talks with us, but we’re there to serve. We make sure that we have open communications at all times, and I think that’s how we avoid these issues.

Kerri Anderson:
Yeah, absolutely. I think that’s incredible advice for any ops leader, whether you’re an R&D or the environment you’re in, just understanding the why of the science going on and how you can best be there and support. It’s a great approach. So I had another question, I’m curious. This is a funny one, but you mentioned overseeing the building, the facility as a whole, and that’s everything from pests to a lot that can go on within operations. What’s one of the funniest things that you are now overseeing that you maybe didn’t expect to?

Omri Paran:
So I, kind of everything. Ask me like how a TV show is, how a movie is, how a restaurant is, I’ll just tell you, it’s great, love it, or, and so I’m famously not picky when it comes to snacks or cafeteria facilities, but I notice with my employees and especially with, when two other facilities of ours and the East Coast, I noticed other clients there’s a, there’s suggestion boxes, and there’s so many complaints of, about the cafeteria facility that we provide. You know, we have snacks and drinks, we have this beverage machine, the bean-to-cup coffee machine that’s, I think it’s the most delicious coffee that there is, but so many complaints. I manage everything in the facility. I manage like even the bathrooms. I’m even, I’m the food and beverage coordinator, too. So that’s the most surprising, is that the hardest place to get people to agree and to be happy is in the cafeteria.

Kerri Anderson:
I definitely relate to that. Always the surprising one.

Samantha Black:
People love their snacks. They’re very picky about it.

Omri Paran:
Yeah, they are.

Samantha Black:
I think you did such a great job at answering our questions, like you’ve packed so much information into all of those. But I think, just to finish up here, I think you have a lot more to share with people. And if somebody wants to find out more about what you do or maybe learn from you, can they find you, are you open to connecting with people and sharing more about your story? And how can somebody do that?

Omri Paran:
So I don’t do the social things too much, but I’m on LinkedIn, and so anyone can find me there. And yeah, I’m definitely open to talk with anybody who’s interested and to learn from them too.

Samantha Black:
Awesome. Thank you, Omri, this has been a wonderful conversation. Thank you for spending the time to share your story with us today. We really appreciate it, and we wish you the best of luck.

Omri Paran:
Thanks, Samantha. Thanks, Kerri.

Kerri Anderson:
Thank you for tuning in to this episode of the LabOps Leadership podcast. We hope you enjoyed today’s guest.

Samantha Black:
For show notes, resources, and more information about LabOps Unite, please visit us at LabOps.Community/Podcast. This show is powered by Elemental Machines.

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