Lead Scientist, Purification Process Development

Cyprotex Limited; Redmond (WA); On-site; USD 126,000 - 137,000; Full time

Job summary

Just-Evotec Biologics’ Purification Process Development group seeks a Senior Scientist I to lead a diverse team in purification process development, characterization, and technology transfer to cGMP manufacturing for hybrid and continuous processes.

You will design and analyze experiments, mentor staff, and collaborate with external partners, applying high throughput screening, DOE, and process modeling to advance low-cost biotherapeutics.

Qualifications

• BS/MS with 8+ years of experience or PhD with 4+ years.
• Expertise in purification technology and transfer to cGMP manufacturing; CMC writing.
• Experience with commercial process development, characterization, and validation.
• DOE and statistical analysis expertise.
• Leadership of development teams for external client projects and collaborations.
• Experience with high throughput process development systems is a plus.
• Experience analyzing data in JMP, R, or Python.
• Knowledge of GMP/cGMP environments and experience with regulatory filings.

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.

Skills

Chromatography

Filtration

High throughput screening

Process modeling

Multicolumn chromatography

DOE

Statistics

Python

R

JMP

Leadership

Communication

CMC writing

Regulatory knowledge

Education

BS/MS in Engineering,Biochemistry,Biology,or related field

PhD in Engineering,Biochemistry,Biology,or related field

Tools

Microsoft Office

Google Suite

Job description

Just-Evotec Biologics’ Purification Process Development group seeks a Senior Scientist I to lead a diverse team in purification process development, characterization, and technology transfer to cGMP manufacturing for hybrid and continuous processes.

You will design and analyze experiments, mentor staff, and collaborate with external partners, applying high throughput screening, DOE, and process modeling to advance low-cost biotherapeutics.