Senior Scientist I, Purification Process Development

Role Summary

Senior Scientist I, Purification Process Development, leads purification process development, characterization, and validation, and oversees technology transfer to cGMP manufacturing for hybrid and continuous processes. The role also serves as an internal technical resource for cGMP manufacturing and Process Design, and as a subject matter expert for external clients and partners on purification processes. Based in Seattle, WA.

Responsibilities

• Leading a diverse group of scientists encompassing all aspects of purification process development, characterization, and validation as well as technology transfer to cGMP manufacturing for hybrid and continuous processes.
• Serving as an internal technical resource for cGMP manufacturing and Process Design as well as a resource and subject matter expert for external clients and partners for purification processes (small scale models, process transfer, and scale up) including authoring CMC regulatory sections.
• Serving as a functional area lead for platform or complex client early-stage (FIH) and late-stage Process Characterization (PC) projects as well as technology development projects.
• Serving as a Project Team Lead within the process development organization to execute on client projects that involve multiple functional areas for platform, early-stage (FIH) projects.
• Clearly and effectively communicating scientific information, experimental plans, and data to internal project teams, senior management, external clients, vendors, and technology development collaborators.
• Independently designing, executing, and analyzing statistically designed experiments (DOE).
• Authoring SOPs, reports, and slides which summarize, organize, and interpret experiment results with review by appropriate team members.
• Training, mentoring, and supervising staff and interns.
• Driving technology development for process intensification and continuous manufacturing to reduce manufacturing costs and footprint through improvements in culture productivity, control of product quality, and data management.
• Supporting the management of staff, capital resources, and planning within the department.
• Other tasks as assigned.

Qualifications

• BS/MS in Engineering, Biochemistry, Biology, or related field with 8+ years of experience or Ph.D. in Engineering, Biochemistry, Biology, or related field with 3+ years of experience.
• Expertise in purification technology and process development, transfer to cGMP manufacturing plants, and authoring CMC sections of regulatory filings.
• Experience with commercial process development, process characterization, and validation.
• Expertise in design of experiments (DOE) and statistical analysis.
• Experience in training, mentoring, and supervising team members as well as leading development teams for external client projects and collaborations and internal technology development initiatives.
• Experience with high throughput process development systems is a plus.
• Experience analyzing data in tools such as JMP, R, or Python.
• General understanding of cell biology, fluid dynamics, and protein chemistry as well as knowledge in other functional areas (upstream and analytical sciences).
• Experience working in a cGMP or clean room setting (this job is non-GMP but knowledge of GMP is helpful for process/tech transfer activities).