Scientist, Pharmaceutical Science​/ Research, Biotech Research

Requisition

Location:

Bothell, WA, US

Do you want to join a team where the mission is meaningful, the challenges are complex, and you can directly see the results of your hard work? Lundbeck Seattle Bio Pharmaceuticals (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. Join us on our journey to advance brain health and transform lives.

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.

• 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.

• 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.

• BS or advanced degree in Chemical Engineering, Biochemical Engineering,…