James Park discusses Lotte Biologics' strategy to establish itself as a global CDMO through dual manufacturing hubs in the US and Korea, advanced biologics and ADC capabilities, and a strong service-oriented culture. He outlines the company's expansion plans, technological differentiation, and support for Korea's emerging biotech ecosystem, while reflecting on cross-cultural leadership and the country's growing role in global biopharmaceutical manufacturing.
Could you introduce yourself to our international readers, and tell us a little about your background?
I joined the company at the end of 2024; prior to that, I spent several years as CEO of GC Cell, a cell and gene therapy company with a strong R&D focus, alongside a smaller CDMO component. Before that, I spent seven years at Samsung Biologics, heading global sales and operations, and prior to my time in Korea, I worked across several pharmaceutical companies in the US, including Bristol Myers Squibb, Merck (known as MSD outside the US), and Janssen. In total, I have more than 30 years of experience in the pharmaceutical industry.
My academic background is in chemical engineering, with a bachelor’s degree, followed by a master’s in operations research and management engineering. I began my career as a process engineer before eventually transitioning to the business side, focusing on licensing and out-licensing opportunities. In 2015, I had the opportunity to come to Korea to join Samsung Biologics, a CDMO. I did not anticipate staying this long, but this is now my eleventh year in Korea. Despite being Korean American, I had to adjust to the very different work culture here, and I have genuinely enjoyed learning and working here over the past decade.
Why did Lotte decide to enter biologics, despite the scale and capital intensity of the sector?
I was not directly involved when Lotte Group made that initial decision, but the rationale mirrors what we have seen from other large international companies: identifying the next major growth engine for the group. Given the ageing global population, there will be sustained demand for new medicines and new therapeutic platforms, and biologics, still a relatively young field at roughly 20 years old, has considerable runway ahead of it. This sits alongside adjacent and increasingly prominent platforms such as ADCs and various bispecific and multispecific formats, as well as continued long-term potential in cell and gene therapy despite its current slowdown.
Lotte Group is well known across Asia Pacific, having originated in Japan before expanding into Korea, but it carries far less brand recognition in the US or Europe. Given how challenging and competitive the research side of the pharmaceutical industry already is, entering as a CDMO offered a faster route into the broader healthcare space. The company’s entry into biologics began with the acquisition of a BMS manufacturing facility in the US, which became the foundation of our CDMO business. The group acquired a facility with a genuinely rich history in product development, technology transfer, commercialisation, and regulatory and quality compliance, our current Syracuse site. At the same time, recognising the need for scale to compete with established CDMO players, they invested heavily in building considerably larger capacity in Songdo, South Korea. Operating dual sites across the US and Korea gives us meaningful flexibility to support clients across both regions, which has proven particularly valuable given the geopolitical environment of the past few years.
Having a US-based site has been a considerable advantage, particularly for clinical supply and commercial manufacturing within the US market. But the value goes beyond geography alone: we invested in and built our ADC manufacturing facility for bioconjugation, enabling ADC production beginning from January 2025. And we are already seeing strong inbound interest from potential ADC clients as a result. Songdo, meanwhile, offers considerably greater scale, 120,000 litres of capacity compared to 40,000 litres in Syracuse, giving us the flexibility to bring a product in at the clinical stage through Syracuse, and, as it scales toward peak demand, transfer manufacturing internally to Songdo for larger-volume production, with meaningful cost-of-goods benefits.
What mandate were you given when you became CEO, and what are your priorities today?
A CDMO business fundamentally depends on securing manufacturing orders and contracts to commercialise client products. I had a track record of doing exactly that at my previous company, bringing in manufacturing orders across multiple facilities, and that history is largely what drew Lotte Group to bring me on board to replicate that success here. I think of this personally as something of a “CDMO 2.0” chapter for me. While my prior experience was rooted in sales, operations and business development, stepping into the CEO role at LOTTE Biologics required considerably more: getting our facilities genuinely ready, managing operations across two sites simultaneously, and, critically, using that same BD and sales foundation to bring in new clients, which remains central to growing any CDMO business. That combination, replicating past success while managing a multi-site operation as CEO within a major Korean-US conglomerate, was really the opportunity in front of me.
In an increasingly competitive CDMO market, what differentiates Lotte Biologics?
That is always a challenging question to answer well, but one genuine differentiator is that we established a US presence early. Converting an existing pharmaceutical manufacturing facility into a functioning CDMO takes considerable time, both operationally and in shifting internal mind-set from supporting captive, internal demand to serving multiple external clients across varying product stages. That transition took us a few years, but we have largely completed it. We are also building an entirely new facility around modern smart-factory automation, alongside N-1 perfusion capability supporting considerably higher titres. Where historical titres sat around one to two grams per litre, modern technology now reaches up to ten grams per litre, so we built N-1 capability into our 3,000-litre production bioreactors, allowing product to be pulled directly from that stage into downstream purification, alongside 15,000-litre capacity, giving us real flexibility in harvest bioreactor sizing. Combined with our smart-factory automation, which allows us to monitor process parameters in near real time to optimise yield, this represents genuinely new capability for our facility.
Equally important is the people we retained alongside the BMS facility itself, roughly 500 individuals bringing 15 to 20 years of experience manufacturing biologics. That expertise is now being actively transferred into Songdo, where we are simultaneously hiring a large number of people, including new graduates and running structured cross-training programmes between Syracuse and Songdo, allowing knowledge and skills to cross-pollinate across both sites. This is something our competitors did not have in the same way when they began; while some have since acquired their own US facilities, converting them will similarly take time, which gives us a genuine head start in that respect. Our task now is converting that advantage into new client relationships across both sites.
With much of today’s ADC innovation originating in China, how important are Chinese biotechs to your growth strategy?
Our strategic focus has followed the broader trend from traditional monoclonal antibodies through bispecifics and trispecifics toward ADCs, which is why we built bioconjugation capability in Syracuse, scaling from 100 litres up to 1,000 litres. There is clearly strong momentum in the ADC space, and we are seeing considerable client interest as a result. Having that capability based in the US matters for geopolitical reasons, but also practically: since the US remains the largest pharmaceutical market, most clinical studies are ultimately conducted there, making a US-based supply chain genuinely advantageous. A further benefit is that our Syracuse campus houses both monoclonal antibody drug substance manufacturing and bioconjugation under one roof, meaningfully simplifying the overall supply chain.
As for Chinese companies specifically, there is undeniably a great deal of ADC innovation emerging from China. But any company ultimately pursuing approval in the world’s largest market will need to run clinical studies in the US. A modern, well-located US facility, backed by experienced operators and larger available capacity, positions us well to attract that client base, alongside others, regardless of their geographic origin.
How would you describe your current client mix between biotech and larger pharmaceutical companies?
Broadly, Syracuse is oriented more toward biotech and mid-sized companies, supporting programmes from clinical development through to launch, while our larger Songdo facility is positioned around commercial-scale and soon-to-be-commercial products. That said, the two sites work together: as a product’s volume grows, we can transfer manufacturing from Syracuse to Songdo, giving clients flexibility across both scale and location for a single product. I could not give you an exact percentage split, but our strategy spans both segments, supported by strong development capability in Syracuse, including process development, scale-up, technology transfer, and master cell bank capability, which allows us to support a product from early development right through to launch, before scaling further as needed.
How important has your US manufacturing footprint become in client discussions, particularly as supply-chain resilience has moved up the agenda?
Over the past year or two, it has come up frequently, largely driven by geopolitical factors and tariff policy discussions coming out of the current US administration. Even where pharmaceutical companies are building their own internal US manufacturing capacity, my experience across the industry tells me they will still want an alternate, external source, since redundancy genuinely benefits both the company and the product. So even companies investing in their own domestic capacity remain drawn to CDMO partners with a US presence, which is naturally true for our competitors as well. Much of this ultimately depends on a given client’s specific needs; for smaller or mid-sized companies still developing their product, our roughly five-thousand-litre scale in Syracuse tends to sit in something of a sweet spot, well suited to late-phase development and initial launch, particularly given how uncertain early commercial uptake can be, compared to considerably larger-scale facilities elsewhere.
How close is the Songdo facility to full operational readiness, and what role will automation play?
The facility was originally targeted for GMP readiness by around April 2027. We completed mechanical completion in June of this year, 2026, and have since worked to accelerate the GMP timeline by five to six months, now targeting operational GMP status by November. Based on direct conversations with a number of potential clients seeking faster timelines, we recognised real value in dedicating additional effort, resources and capital to accelerate that schedule, which has been a core focus for us throughout the first half of this year. We are making strong progress and remain hopeful of reaching operational status by November rather than next April, and that accelerated timeline has already generated additional client interest.
On automation specifically, we have not yet demonstrated this at commercial scale, since we do not yet have a client running through the facility, but we do have a pilot plant on-site, supporting work at up to 500 litres, allowing us to conduct smaller-scale process work upfront and execute faster technology transfer into commercial scale. Combined with our broader smart-factory and automation approach, this should allow us to move technology from small scale to full commercial capacity considerably faster, and we anticipate that advantage is already helping support early client conversations ahead of the facility formally opening.
With biotech venture funding remaining relatively selective, how do you plan to fill that capacity without resorting to global price competition?
Price is certainly one factor, but quality and on-time delivery matter just as much, and while every CDMO claims strength in both, we recognise we still have work to do to fully compete with more established competitors. That said, we are confident in what Lotte Group’s broader heritage brings to this business: a deep, consistent focus on service, which runs through every part of the group, from retail to food and beverage, and now into biologics. Translating that same service-first culture into our operating model, and consistently delivering what clients genuinely need, remains our central focus and, I believe, our best path to sustainably filling capacity.
What role do you see Lotte Biologics playing in the development of Korea’s biotech ecosystem through Bio-Venture initiative?
This is genuinely exciting to be part of. Having spent roughly 30 years in this industry, I remember a time when US pharmaceutical companies simply did not look toward Korean biotech at all, two or three decades ago, that would have seemed unlikely. Today, that has changed entirely; companies like Alteogen and LigaChem Biosciences have secured substantial licensing agreements with partners such as GSK, reflecting how significantly Korean innovation and clinical data quality have advanced over the past decade or two, and that progress is now being genuinely recognised internationally.
As a CDMO, we cannot reasonably expand into every area, particularly research, which is an intensely competitive space on its own. But we can meaningfully support innovative, early-stage biotech companies as they develop their products and shape their research strategy, much as similar initiatives operate around Boston’s biotech ecosystem. We are pursuing something similar here in Korea, and given the Korean government’s strong current support for both AI and biotech, working closely with government visibility and grant support to help smaller biotech companies grow feels like a genuine win, for us, for those companies, and for Korea’s broader biotech ecosystem. Companies like Alteogen and LigaChem likely started in comparable circumstances, and if we can help identify and support the next generation of companies like them, that would be a genuinely rewarding outcome for everyone involved.
Having worked extensively in both the US and Korea, what differences do you see between teams in each market, and what might each learn from the other?
Korean work culture is often defined by the concept of “pali pali,” meaning quickly, quickly, and that mind-set extends well beyond the workplace into daily life generally. Koreans take real pride in moving fast and delivering results efficiently. American teams, by contrast, may not always move at the same pace, but tend to bring considerable dedication, persistence, and a clear, mature understanding of process and what is genuinely required to reach the intended outcome. That is precisely why I emphasise cross-pollination between our Korean and US teams: drawing on the best practices from both sides to build what I think of as the best of both worlds, which I hope becomes a genuinely effective operating model going forward.
As a final message, what should potential clients and partners considering Korea, and Lotte specifically, know about you as a partner?
We are admittedly still a relatively young CDMO and a later entrant to the market, but we bring genuine eagerness to deliver strong service across every part of our business. Give us the opportunity, and you will find a company that is young, yet genuinely experienced, having inherited a legacy BMS facility and a team carrying 15 to 20 years of hands-on manufacturing expertise. As I mentioned, combining the best of both worlds gives us real flexibility, both in terms of capability and capacity, as well as location. Whenever you need us, we are here. And while Lotte Group carries a rich, well-established history across Asia Pacific, our ambition going forward is to build that same recognition across the US and Europe too.
