Principal Scientist, Biologics Process Development - Downstream Purification

Principal Scientist, Biologics Process Development
- Downstream Purification Catalent is seeking a Principal Scientist, Biologics Process Development
- Downstream Purification to support late-stage biologics process development, technology transfer, and commercialization activities for therapeutic proteins and antibodies.

This is a highly visible, client-facing Process Development role supporting the advancement of biologics programs across a diverse portfolio of mAbs, bispecific antibodies, and recombinant proteins. While approximately 25% hands-on laboratory based, the majority of the role focuses on technical leadership, program management, and guiding teams through downstream purification process development activities including chromatography, UF/DF, filtration, viral clearance, and cell removal processes.

The successful candidate will bring significant industry experience in biologics purification and downstream process development, with a strong understanding of late-stage development, process characterization, technology transfer, and manufacturing readiness. Candidates should possess hands-on expertise in at least one of the following areas: monoclonal antibody (mAb) purification, bispecific antibody purification, or recombinant protein purification.

About Catalent Madison Catalent's Madison, Wisconsin facility is a state-of-the-art biologics development and manufacturing site supporting customers from research through early- and mid-stage clinical production. Located at 726 Heartland Trail, the 102,700-square-foot GMP facility specializes in mammalian cell line engineering, drug substance manufacturing, and biopharmaceutical process development. The site is home to Catalent's proprietary GPEx and GPEx Lightning technologies, enabling the generation of high-producing mammalian cell lines for biologic therapies.

With production capabilities ranging from 50L to 4,000L and a recent $45 million expansion, the Madison campus continues to play a critical role in Catalent's global biologics network while supporting Wisconsin's growing life sciences industry.

Location:

100% Onsite at our facility in Madison, Wisconsin

Shift: Monday – Friday, First Shift  

Key Responsibilities Technical Leadership & Scientific Strategy:
Serve as the scientific lead for downstream process development programs supporting monoclonal antibodies (mAbs), bispecific antibodies, and recombinant protein therapeutics. Provide strategic direction, scientific consultation, and technical oversight across multiple client programs, with a focus on purification process development, scale-up, technology transfer, and commercial readiness.

Process Development Oversight:
Guide the design, development, optimization, and characterization of downstream purification processes, including chromatography, ultrafiltration/diafiltration (UF/DF), viral filtration, clarification, and cell removal methodologies to enable successful clinical and commercial manufacturing.

Client Partnership & Program Management:
Act as the primary technical contact for client development projects, leading meetings, communicating project status, providing scientific rationale, and ensuring alignment between technical execution and program objectives.

Technology Transfer & Commercial Readiness:
Lead technology transfer activities, process characterization studies, scale-up strategies, validation readiness initiatives, and viral clearance programs supporting progression from development through cGMP manufacturing and commercialization.

Cross-Functional Leadership:
Collaborate with Process Development, MS&T, Manufacturing, Quality, Regulatory, and Analytical teams to drive project execution, troubleshoot technical challenges, and ensure successful project…