article

Q&A with Jim Sulzberger, Director of CMC

Experience

With 17 years of broad experience in the biopharmaceutical industry, Jim Sulzberger has held progressive technical and commercial leadership roles, driving innovation in process development, analytical methodologies, and manufacturing. His expertise spans recombinant protein development, scale-up strategies, and regulatory compliance, positioning him as a key industry leader in biologics and pharmaceutical manufacturing in the area of Chemistry Manufacturing and Controls (CMC).

Before joining Sapio, Jim served as Senior Director of Protein Science at COUR Pharmaceutical Development Company, where he led all aspects of recombinant protein process development, analytical methods, manufacturing operations, and facility design. Prior to that, as Technical Director at Aldevron, he played a pivotal role in guiding clients through drug substance manufacturing process design while also overseeing internal technical process development, scale-up, and technology transfer.

Preceding this, Jim held key technical leadership roles at Bio-Rad Laboratories and Pall Corporation, expanding his expertise in bioprocessing solutions and advanced manufacturing technologies. He began his career at Celgene, where he played a critical role in ensuring the quality and stability of lyophilized oncology nanoparticles for commercial release, gaining foundational experience in analytical testing and regulatory compliance.

Most recently, Jim has provided strategic consulting and hands-on leadership in analytical development, process optimization, scale-up, validation, and CMC submissions—guiding drug candidates from early discovery through Phase 2B clinical trials.

Throughout his career, he has worked closely with global biopharmaceutical and pharmaceutical companies to align process development strategies with critical quality attributes, ensuring cost-effective scalability and regulatory compliance. Along with his deep expertise in CMC, he has specialized experience and is considered an industry SME for modern areas such as design of experiments (DOE), process intensification (PI), continuous chromatography (McC), and mixed-mode chromatography (MMC).

These strengths, combined with his extensive experience in analytical, process development, and quality environments, provide him with a unique and comprehensive perspective, enabling him to effectively navigate complex industry challenges and drive innovative solutions for the life sciences industry.

Education and Certifications

Master of Science in Chemistry (Emphasis in Separation Sciences)
Northeastern Illinois University, Chicago, IL

Bachelor of Science in Biology
University of Illinois at Chicago, Chicago, IL

Certificate in Implementing Enterprise-Wide Transformation
MIT Sloan School of Management, Cambridge, MA

Publication, Presentation, and Advisory Role

Making the Move to Continuous Chromatography, BioPharm International, Volume 131, Issue 4 

Process Intensification Using Membrane Chromatography, BioProcess International West, Speaker 

Efficient Purification of a Recombinant Protein from E. coli Fermentate with Mixed-Mode Chromatography Resins, ACS BIOT, Speaker and Poster Presentation 

Process Intensification and Downstream Manufacturing: Defining Current Challenges and Exploring Future Perspectives, Biotech Week Boston (BPI East), Key Opinion Leader Panel Member/Speaker

Q&A with Jim

Q: What initially drew you to life sciences?

A: From a young age, I’ve been passionate about creating and experimenting, starting with a child’s chemistry set. Initially, I entered high school with the intention of pursuing medical school. However, my trajectory shifted when my biology teacher, who also coached my cross-country team, introduced me to a project focused on producing green fluorescent protein. That experience sparked my fascination with scientific research, and from that moment on, I knew that was the path I wanted to follow

Q: What do you enjoy most about working in life sciences, and what do you consider your major accomplishments?

A: I enjoy the challenge of reducing the cost of potentially life-saving therapeutics through thoughtful process development, process intensification, and the creation of specific analytical methods with pinpoint accuracy and precision. My specialization lies in downstream process and analytical development, as well as subsequent scale-up and validation — encompassing a significant portion of the CMC component of regulatory submissions. This work allows me to contribute to making treatments more accessible while ensuring they meet the highest quality standards. 

Significant achievements include developing scalable manufacturing processes and analytical methods for diverse and complex products, such as a monoclonal antibody-based COVID-19 vaccine in Switzerland, recombinant proteins for Type 1 diabetes, and innovative reagents for AAV precipitation, significantly optimizing downstream processes. Additionally, I was granted a provisional patent for a groundbreaking two-step purification process that modernized legacy workflows by reducing steps from four to two, leveraging advanced chromatography resins. 

Q: What drew you to Sapio Sciences?

A: As a scientist, I know firsthand that one of the most tedious and costly aspects of developing a therapeutic is screening and narrowing drug candidates. This process, coupled with the authorship of development and validation protocols and reports, can be incredibly time intensive. Beyond that, it can often feel like a scramble to aggregate and organize data for regulatory submissions. The Sapio Laboratory Informatics Platform, with its ELN, LIMS, and AI-driven solutions drastically reduce the burden in these areas. Sapio’s streamlining of data management and providing intelligent tools for data aggregation and molecule evaluation has the potential to transform how we approach these critical, previously resource-heavy, phases of drug development. I want to be part of that.

Q: What activities do you enjoy outside of work, and do you support any special causes?

A: I ran cross-country in high school and college, and I now enjoy staying active through running and biking. I also have a passion for motorcycles, and I participate in 8-ball billiards competitions. I live in Chicago, where I’m a life-long Cubs fan and never miss a chance to cheer them on — win or lose. I volunteer regularly for Meals on Wheels and Alzheimer’s Association, and I attend and participate in fund raising events such as Tour de Cure for the American Diabetes Association.