Scientist I

About the Role

Lundbeck Seattle BioPharmaceuticals (Lu-SBP) is seeking a Scientist I for the Downstream Process Development team. This team develops processes for therapeutic biologic candidates across preclinical, clinical, and late-stage development. The primary responsibility is to develop scalable and robust purification processes for protein production at clinical and commercial scales. This role involves collaboration with upstream, analytical, and formulation development groups.

Key Responsibilities

• Design, execute, and interpret complex downstream process development studies for biologics programs.
• Serve as a subject matter expert in downstream processing, focusing on Chromatography, Ultrafiltration/diafiltration (UF/DF), Depth filtration, Viral inactivation, and Viral filtration.
• Apply strong experimental design principles to develop efficient and scientifically rigorous studies addressing process performance, robustness, and scalability.
• Independently analyze complex experimental datasets, identify trends and risks, and translate results into technical conclusions and recommendations.
• Author and review technical reports, development documents, presentations, and protocols supporting process development.
• Present scientific strategy, experimental results, recommendations, and technical risks to project teams and senior stakeholders.
• Serve as the Downstream Process Development functional-area lead on cross-functional development programs.
• Partner with Manufacturing and other technical functions to support process scale-up and technology transfer to internal or external facilities.
• Provide technical support during manufacturing implementation, including troubleshooting and resolution of process-related issues.
• Collaborate effectively across organizational and geographic boundaries with clear communication and follow-through.

Requirements & Tech Stack

• Bachelor’s degree and 8+ years’ experience in the biopharmaceutical industry OR Masters and 6 years’ experience OR PhD and 0-2 years’ experience OR a 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.

Qualifications (Preferred)

• 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.