Scientist I - Downstream Process Development

About the role

Lundbeck Seattle BioPharmaceuticals (Lu-SBP), located in Bothell, Washington, is the Process Development Center of Excellence for Biologics within the global Lundbeck CMC organization. Since integrating into Lundbeck in October 2019, Lu-SBP has supported commercial launch of Lundbeck’s first biologic product (Vyepti) and advancement of a growing biologics pipeline in collaboration with our Copenhagen-based Process Science & Validation Team. The Lu-SBP team leads and supports the development of new product candidates from cell line development through commercial validation of Drug Substance and Drug Product manufacturing processes.

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.

Responsibilities

• 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.
• Applies strong experimental design principles to develop efficient, scientifically rigorous studies that address process performance, robustness, and scalability.
• Independently analyses complex experimental datasets, identifies trends and risks, and translates 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.

Requirements

• Bachelor’s degree and 8+ years’ experience in biopharmaceutical industry, or Master’s 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.

Qualifications

• 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

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

Pay

Salary range for candidates who will work or reside in the state of Washington: $135,000 - $155,000, with eligibility for a 10% bonus target based on company and individual performance, and eligibility to participate in the company’s long-term incentive plan. Range may vary based on qualifications, skills, competencies, and proficiency for the role.

Benefits

Flexible paid time off (PTO), health benefits including Medical, Dental and Vision, and company match 401k. Additional benefits information is available on the Lundbeck U.S. career site.