Contact Us
Contact Us
Blog Posts

Introducing Jesse Ahrendt, Antheia’s SVP of Quality Assurance & Regulatory Affairs

We’ve recently welcomed Jesse Ahrendt, our new Senior Vice President of Quality Assurance and Regulatory Affairs, who will lead our quality and regulatory efforts. He brings 25 years of experience leading biotech, pharma, and medical device quality systems and compliance, most recently hailing from Zymergen, where he worked with Antheia COO, Zack McGahey. We sat down to speak with him about his background and his vision for Antheia’s future:

Welcome! Tell us a bit about yourself?

I’ve had a varied career, and it’s taken me from small startups to global multinational pharma corporations. I started out studying biology but turned toward industry pretty quickly, taking on a job in a QA/QC laboratory testing environment. I found that I loved exploring the feedback loop between quality assurance and the development of actual products you’re trying to commercialize, and eventually, the impact on patient outcomes.

My first mentor taught me that the quality of a product is only as good as the data you create to support it, and I’ve carried that with me throughout my career. I haven’t always been in pharmaceuticals, but I have always worked in a regulated environment – I started with medical devices, and with the exception of a few stints in consumer care, I’ve been in pharma for the last 21 years.

Tell us how and why you came to Antheia?

I truly believe in the promise and expectations of the bioeconomy, and that Antheia has a central role to play in making it a reality. Today, Antheia has a clear path forward from a quality and regulatory perspective, which means I’ll be supporting the development of quality systems as part of our validation process and scale up, laying a foundation for our commercial product pipeline. This will require extensive collaboration across supply chain, business development, and R&D, from biology to fermentation to downstream purification. It is very exciting.

You exude a lot of energy talking about quality systems – what sparks that excitement?

Oh, it’s a lot of fun! I’m a QA geek at heart, and it brings me a lot of personal joy. I’m sure a lot of people are familiar with Good Manufacturing Practice (GMP); in our case, GMP is really about how we must execute to bring all of the development work to fruition when it is transferred into a commercial manufacturing environment to ensure products have required levels of safety and efficacy. GMP has a lot of written rules, and it has even more unwritten rules that require an extensive amount of time in the industry to learn and truly understand. All of my corporate and consulting experience has helped me hone an understanding of how to navigate those unwritten rules.

I love puzzles, and this work is just that; taking what I know about how the picture has to look, and creating the right puzzle pieces to make the picture look the way it needs to for the company to be successful. This process looks somewhat different for every company and as a pharma company, the puzzle can be even more complex with the pieces being all different shapes and sizes – for me, solving that puzzle is a lot of fun. If I’d told my 22 year old self that, he’d laugh in my face and tell me it sounds boring. But after 25 years, it’s thrilling to me because the challenge is different every single time. And that makes it all worth it.

Quality assurance and regulatory approval is especially important in building industry confidence, but that confidence is not always a given – what do you think are the biggest misconceptions?

When I talk to my friends who are not in pharma, I find that sometimes they have a distorted view of pharma as being full of rather bad actors. But there are some great pharmaceutical companies that are navigating the regulatory landscape, staying nimble within the required quality and safety guidelines, and bringing life-changing therapies to the market. Discovery is accelerating, how we develop new products is evolving, and pharma companies, small and large, are creating opportunities lightyears beyond what we could have predicted – and wrote regulatory guidelines around – 25 years ago. Everyone is adapting to a constantly changing environment.

I think the established industry is also doing a good job of partnering with smaller companies to keep driving innovation. It’s common to see these massive pharma companies with tens of thousands of people and dozens of global factories, but they’re not necessarily always the ones driving the next-generation work. Smaller companies often have more flexibility to pursue major advancements, so you’ll often find the conglomerates partnering with or acquiring smaller teams to expedite drug discovery and innovation.

From the regulatory side, that landscape is incredibly advanced, despite the fact that it isn’t happening at the speeds we’d prefer. There is always a game of catchup, which is a result of rapid discovery and development milestones, and sometimes that gets a hefty dose of criticism. However, I look at the way that the FDA has partnered with manufacturers in the last couple of years to deal with drug shortages. Even though there are still problems, that partnership is much better than it was 25 years ago and I expect that we’ll continue to solve these challenges better and together over time.

Antheia’s core mission is to innovate and transform essential medicine supply chains – tell us more about how you see your role at Antheia in bolstering this mission, and more about the challenges ahead.

Supply chain issues aren’t going away any time soon, and that includes pharma. The question remains how we fix those issues, and keep supply chains moving?

The EO signed last fall underscored the urgency of boosting domestic biomanufacturing capabilities, calling for a coordinated biotech framework to drive innovation and protect consumers from supply chain failures. The sometimes fragile nature of a global supply chain has been a known issue for quite some time but the challenge of the past few years has really brought it to the forefront. I’m excited about being part of a company whose mission and work is specifically addressing this call to action. We’re leading the effort to use biomanufacturing to make pharma supply chains more reliable, cost effective, and localized. It’s a big, exciting opportunity, and we’re at the forefront of this evolution for the industry.

Where do you see Antheia’s positioning in the future?

I envision us as one of the most successful biomanufacturers for substitute agricultural-based KSMs and APIs. Once we have the systems and processes in place, it won’t take a lot to deploy facilities globally, especially considering our pipeline. There’s no shortage of products that we could apply our technology to and I could see us providing product solutions to a very eager global marketplace with manufacturing facilities engaged around the world.

Richard Sherwin

Head of Commercialization

Richard is an industry veteran with more than 30 years of experience in the KSM, API, and intermediate markets. He is responsible for leading the commercialization and revenue generation for Antheia’s robust pipeline of products. Richard brings an exceptional track record of leading international sales teams, driving revenue growth, building strategic partnerships, and delivering innovative products to market, including ANDA and NDA developments. Richard led commercial efforts at some of the leading global pharmaceutical companies and most recently, built his own consultancy business advising a range of clients, including $1B divisions of major multinationals.

Appropriate regulatory submissions will be prepared and submitted to support Antheia’s customers who need to reference and access necessary process-related information.

Yihui Zhu, PhD

Head of Fermentation

Yihui leads the fermentation team at Antheia. With over 25 years of hands-on experience in the field, he brings in-depth knowledge and expertise in microbial metabolism and fermentation process development. He is also skilled in developing comprehensive fermentation data collection, analysis, and visualization systems. Prior to joining Antheia, he served as a fermentation lead at Intrexon and Codexis where he successfully built fermentation labs and teams and led multiple biofuel and biochemical projects to reach stretch milestones and tech transfer. Yihui is passionate about the potential of fermentation and is dedicated to advancing the field through innovative research and development.

Yen-Hsiang Wang, PhD

Head of Strategy, Partnerships, and Finance

Yen-Hsiang leads strategy, partnerships and finance at Antheia. He completed his M.S. and Ph.D. in Bioengineering at Stanford, with extensive research experience in synthetic biology, metabolic engineering and computational modeling. Before joining Antheia, he worked at McKinsey and Tencent with a strong focus in corporate strategy and big data/advanced analytics. At Tencent, he served as Director of Strategy and Business Development for the AI Lab, leading corporate initiatives in healthcare AI/ML applications and commercialization. He also served in AI4H (Artificial Intelligence for Health), a collaboration between WHO and ITU, to establish global standards for AI in healthcare.

Audrey Wang

Head of Financial Planning and Analysis

Audrey leads financial planning and analysis at Antheia. With an MBA from Washington University in St. Louis, Audrey is passionate about leveraging financial analysis, digital technology, and data analytics to guide companies in making optimal investments and strategic business decisions. Audrey has a decade of experience in helping companies solve unique problems and creating long-term impact with unconventional approaches. Before joining Antheia, she was at Vir Biotechnology and Merck where she led various FP&A workstreams, including investment valuation, asset prioritization, and manufacturing sites operation finance support. Audrey completed CFA Level II and passed the U.S. CPA exam in 2011.

Antonij Tjahjadi, CPA

Head of Accounting

Antonij Tjahjadi leads accounting at Antheia and holds active CPA license. He joined Antheia with more than 20 years of experience in corporate accounting, bringing deep expertise in ramping up accounting operations for start-up companies, SEC reporting/technical accounting, and SOX implementation efforts. Before joining Antheia, he held various leading roles in both public and private company settings, including directing accounting functions at Ambys Medicines, where he successfully implemented Netsuite with Point Purchasing integration and set up various accounting policies and processes, and played a key role in the initial public offering of Nutanix, Inc.

Ken Takeoka

Head of Biology

Ken leads the Biology team at Antheia, which incorporates both strain and protein engineering functions. He has more than 16 years of experience in the synthetic biology field, working with leading companies, including Amyris and Novartis. One of his passions is molecular biology tool development and he previously worked to build the foundation for the automated strain engineering pipeline at Amyris. At Novartis, he modernized the molecular biology techniques and established a platform to model mechanisms of antibiotic resistance in a range of organisms.

Suzanne Sato

Head of Downstream Processing

Suzy leads downstream chemistry processes at Antheia. She has 19 years of experience in process development, including route development through synthetic chemistry and scale-up of small molecule APIs for GPCR targets under cGMP for Phase I-III trials. Before joining Antheia, Suzy led a full DSP team at Amyris where she successfully pivoted developments from biofuels hydrocarbon products to pharmaceutical intermediate, flavor, fragrance and nutraceutical products. She led a team that scaled 11 products and took five products to commercial manufacturing.

Farrah Pulce, PMP

Head of Project Management

Farrah leads program and project management at Antheia. She has over 20 years of experience leading program and project management, operations, and engineering for companies across the CPG, aerospace, and automotive industries. Prior to joining Antheia, Farrah implemented and led the sustaining program management team at Impossible Foods. She also led product operations, project management, and cost optimization at Blue Bottle Coffee and Tyson Foods to develop and commercialize new products. As a certified project management professional (PMP), Farrah has a proven record of successful project delivery, improving project management practices, and building collaborative teams.

Jordyn Lee

Head of Communications

Jordyn leads communications and external affairs at Antheia. She brings a decade of multidisciplinary communications experience in helping companies make complex science and technology accessible to broad audiences, all while maintaining technical accuracy and integrity. She has a passion for visionary storytelling and translating impact across the entire communications ecosystem – her work has spanned from public relations to corporate communications to marketing. Jordyn has served as an advisor to a number of different life sciences companies and most recently led corporate communications at Amyris.

Ben Kotopka, PhD

Head of Data Science

As Head of Data Science at Antheia, Ben manages in-house software development and external partnerships for storing and interpreting research data, executing bioinformatics analyses, and streamlining business processes. Prior to Antheia, Ben worked as an academic researcher at the intersection of machine learning, bioinformatics, and synthetic biology. Following this, as an entrepreneur and consultant, he developed and deployed data science solutions for biotechnology applications ranging from metabolomics-driven compound discovery to MRI segmentation.

Guerin Kob

Head of Supply Chain

Guerin is responsible for leading the design, development, management and improvement of Antheia’s end-to-end global supply chain. He has over 15 years of experience leading high-performing supply chain and procurement teams at leading biotechnology and specialty chemical companies, with extensive experience in process development and end-to-end supply chain optimization. Prior to joining Antheia, Guerin served as Senior Director of Global Supply Chain for Sumitomo Chemical’s biotechnology division with Valent Biosciences, where he led the end-to end supply chain including procurement, logistics and distribution, integrated business planning, materials management, customer service, and supply planning functions globally.

Pavel Aronov, PhD

Head of Bioanalytics

Pavel leads the Bioanalytics team at Antheia. He has 20 years of experience in analytical and clinical chemistry, mass spectrometry, chromatography, and metabolomics. Pavel built and led the original Chemistry and Analytics team at Impossible Foods enabling strain development, fermentation, DSP, regulatory, QC, and scale-up of leghemoglobin biomanufacturing. During his academic career at UC Davis and Stanford University Pavel developed a vitamin D assay used by all major clinical diagnostics laboratories and pioneered metabolomics studies to investigate kidney disease and microbiome.

Jesse Ahrendt

Head of Quality Assurance and Regulatory Affairs

Jesse has more than 25 years of experience in regulatory affairs, quality systems, manufacturing quality, and regulated industries, ranging from early- to late-stage pharmaceuticals, biomanufacturing, consumer care, and medical devices. He has supported global product launches and the underlying quality supply chain components in industries that require strict adherence to internationally accepted quality standards. Before Antheia, he led quality efforts at Zymergen and Sandoz, and supported many global pharmaceutical companies during his time in Biotech Consulting at NSF International, all to bring quality to the forefront in manufacturing, standardize global processes, and support customer regulatory requirements.

Heidi Pucel

Chief People Officer

Heidi is a results-driven human resources executive and HR business partner who leverages decades of experience in empowering, motivating, and inspiring to drive transformation within high-performing and rapidly-growing workforces. A certified executive coach and passionate advocate for people-oriented solutions, Pucel serves as a partner to executive teams to design programs that support employee development, engagement, and recruitment and retention. Pucel most recently served as Chief People Officer for Countsy, where she worked as an interim HR executive for clients in the biotechnology and software industries, such as Ceribell and Tune Therapeutics.

Zack McGahey

Chief Operating Officer

Zack is a leading executive in operations management, specializing in bioprocess engineering and manufacturing management. He has over 20 years of experience leading manufacturing functions for companies across the pharmaceutical, synthetic biology, diagnostics, and automotive industries. Before joining Antheia, Zack was VP of manufacturing and capex project management at Zymergen. He also gained experience managing commercial scale facilities operations for Tesla, where he was responsible for managing 10 million square feet of factory, lab and warehouse space during the Model 3 ramp.

Kristy Hawkins, PhD

Co-Founder & CSO

Kristy has over 20 years of experience in the field of synthetic biology, focusing on yeast metabolic engineering for the production of small molecules. She did the founding work on the benzylisoquinoline alkaloid pathway during her graduate studies and gained valuable industry experience at Amyris and Lygos. Kristy is an expert in tool development, high-throughput screening, and host strain and heterologous pathway engineering.

Christina Smolke, PhD

Co-Founder & CEO

Christina is a pioneer in synthetic biology and metabolic engineering, where she has over 20 years of experience. As Professor of Bioengineering and Chemical Engineering at Stanford University, her laboratory led the breakthrough research to engineer baker’s yeast to produce some of the most complex and valuable medicines known. Under her leadership, Antheia’s synthetic biology platform enables new possibilities for drug discovery and efficient, sustainable, transparent, and on-demand drug manufacturing at scale. Her vision and accomplishments have garnered numerous awards, including the Chan-Zuckerberg Biohub Investigator, NIH Director’s Pioneer Award, Nature’s 10, Novozymes Award for Excellence in Biochemical Engineering, and TR35 Award.

U.S. Secretary of State Antony J. Blinken visits Antheia to discuss biotechnology innovation

Appropriate regulatory submissions will be prepared and submitted to support Antheia’s customers who need to reference and access necessary process-related information.