Scientist I - Downstream Process Development
About The Position
The Scientist I is part of Lundbeck Seattle BioPharmaceuticals’ Downstream Process Development team, which develops processes for therapeutic biologic candidates in preclinical, clinical, and late-stage development. The role focuses on developing scalable, robust purification processes that produce proteins within targeted product quality profiles for clinical and commercial scales. The Scientist I collaborates extensively with upstream, analytical, and formulation development groups and serves as the downstream functional-area lead on cross-functional programs. The position involves designing, executing, and interpreting complex process-development studies; supporting scale-up and technology transfer; and providing technical support during manufacturing implementation. Domestic and international travel of up to 20% may be required. The position is based in Bothell, Washington. The listed salary range for potential hires working or residing in Washington is $135,000–$155,000, with eligibility for a 10% bonus target and participation in the company’s long-term incentive plan.
Requirements
- Bachelor’s degree and 8 or more years of biopharmaceutical industry experience; or a master’s degree and 6 years of experience; or a PhD and 0–2 years of 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.
- Skill in Unicorn-based AKTA programming and result evaluation.
Nice To Haves
- 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, 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 establishing proven acceptable ranges or process operating ranges.
- Experience supporting regulatory filings or responding to technical questions related to downstream process development.
- Experience leading a functional area on a cross-functional development program and/or leading complex technical project teams.
- Ability to coordinate activities across multiple functions, communicate priorities, identify risks, and drive decisions.
- Excellent verbal and written communication skills, including the ability to explain complex technical concepts to technical and non-technical audiences.
- Strong organizational and project-management skills, including the ability to manage multiple priorities and deliverables.
Responsibilities
- Design, execute, and interpret complex downstream process-development studies for clinical and commercial biologics programs.
- Apply downstream-processing expertise, especially in chromatography, ultrafiltration/diafiltration (UF/DF), depth filtration, viral inactivation, and viral filtration.
- Design efficient, scientifically rigorous experiments addressing process performance, robustness, and scalability.
- Analyze complex experimental datasets, identify trends and risks, and translate findings into technical conclusions and recommendations.
- Author and review technical reports, development documents, presentations, protocols, and other process-development documentation.
- Present scientific strategy, experimental results, recommendations, and technical risks to project teams and senior stakeholders.
- Lead the Downstream Process Development functional area 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 resolving process-related issues.
- Collaborate across organizational and geographic boundaries with clear communication and follow-through.
Benefits
- Flexible paid time off (PTO).
- Medical, dental, and vision health benefits.
- Company-match 401(k).
- Eligibility for a 10% bonus target based on company and individual performance.
- Eligibility to participate in the company’s long-term incentive plan.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
