Scientist I - Downstream Process Development

Position Summary

The Scientist I is a part of the Downstream Process Development team. This collaborative team develops processes for therapeutic biologic candidates in preclinical, clinical, and late-stage development. The primary responsibility will be to develop scalable and robust purification processes that produce protein within targeted product quality profile for clinical and commercial scales. This individual plays a synergistic role within downstream group and will collaborate extensively with members of upstream, analytical and formulation development groups.

Essential Functions

• Designs, executes, and interprets complex downstream process development studies supporting clinical and commercial biologics programs.
• Serves as a subject matter expert in downstream processing, with particular emphasis on Chromatography, Ultrafiltration/diafiltration (UF/DF), Depth filtration, Viral inactivation and Viral filtration.
• Apply strong experimental design principles to develop efficient, scientifically rigorous studies that address process performance, robustness, and scalability.
• Independently analyses complex experimental datasets, identify trends and risks, and translate results into clear technical conclusions and recommendations.
• Authors and reviews technical reports, development documents, presentations, protocols, and other documentation supporting process development activities.
• Presents scientific strategy, experimental results, recommendations, and technical risks to project teams and senior stakeholders.
• Serves as the Downstream Process Development functional-area lead on cross-functional development programs.
• Partners with Manufacturing and other technical functions to support process scale-up and technology transfer to internal or external manufacturing facilities.
• Provides technical support during manufacturing implementation, including troubleshooting and resolution of process-related issues.
• Collaborates effectively across organizational and geographic boundaries while maintaining clear communication and strong follow-through.

Required Education, Experience, and Skills

• Bachelor’s degree and 8+ years’ experience in biopharmaceutical industry or Masters and 6 years’ experience, or PhD and 0-2 years’ experience or relevant combination of education and experience.
• Extensive knowledge of the scientific principles and practical execution of protein purification using column chromatography and filtration techniques including UF/DF, depth filtration, viral inactivation, and viral filtration.
• Demonstrated ability to independently design scientifically rigorous experiments and interpret complex datasets.
• Skilled in Unicorn-based AKTA programming and result evaluation.

Preferred Education, Experience, and Skills

• BS or advanced degree in Chemical Engineering, Biochemical Engineering, Bioengineering, Biotechnology, Biochemistry, or a related scientific or engineering discipline.
• Experience supporting late-stage process development, process characterization, validation readiness, or commercial process development.
• Familiarity with viral clearance for early and late-stage programs.
• Experience supporting technology transfer activities, including preparation of process descriptions, transfer documentation, risk assessments, and manufacturing support.
• Hands-on experience with pilot-scale downstream processing equipment and operations.
• Familiarity with process characterization, scale-down model qualification, and establishment of proven acceptable ranges or process operating ranges.
• Experience supporting regulatory filings or responding to technical questions related to downstream process development.
• Demonstrated experience leading a functional area on a cross-functional development program and/or leading complex technical project teams.
• Ability to effectively coordinate activities across multiple functions, communicate priorities, identify risks, and drive decisions.
• Excellent verbal and written communication skills, including the ability to communicate complex technical concepts to both technical and non-technical audiences.
• Strong organizational and project-management skills, with demonstrated ability to manage multiple priorities and deliverables.

Travel Requirements

Domestic and international travel up to 20% may be required.