Senior Scientist I, Purification Process Development

Cyprotex Limited; Redmond (WA); Vor Ort; USD 126.000 - 137.000; Vollzeit

Zusammenfassung

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.

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

Chromatography

Filtration

High throughput screening

Process modeling

Multicolumn chromatography

DOE

Statistics

Python

R

JMP

Leadership

Communication

CMC writing

Regulatory knowledge

Ausbildung

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

PhD in Engineering,Biochemistry,Biology,or related field

Tools

Microsoft Office

Google Suite

Jobbeschreibung

Job Title: Senior Scientist I, Purification Process Development

Location: Redmond, WA

Reports to: Director, Process Sciences

About Us:

At Just-Evotec, we believe that curiosity is the spark that drives innovation and success. As a forward-thinking team, we thrive on challenging the status quo, learning from each other, and pushing the boundaries of what’s possible. We’re on a mission to create a place where curiosity isn’t just encouraged, it’s celebrated.

Are you someone who asks questions, seeks answers, and isn’t afraid to go deeper? #BeCureious with us and see where your curiosity can take you!

The Role:

Just-Evotec Biologics’ Purification Process Development group is seeking an enthusiastic and hardworking team member who is passionate about expanding worldwide access to biotherapeutics through the advancement of continuous bioprocessing technology.

This person will join a fast-paced, collaborative, and multidisciplinary team to support purification process development at the bench and pilot scale for the advancement of low-cost biotherapeutics manufacturing. Process design at Just-Evotec means exposure to innovative technologies like high throughput automated robotic screening and continuous processing technologies for a first-of-its-kind flexible and reconfigurable manufacturing facility.

The successful candidate will have experience in chromatography and filtration theory and operations. Experience with high throughput chromatography screening, chromatography mechanistic modeling, multicolumn chromatography, and process modeling is a plus. The ideal candidate will have strong scientific group management and leadership skills as well as a proven track record of a deep understanding of purification process development. Strong written and verbal communication skills are required as well as experience in client and multi-site communication. Experience with common software packages (such as Microsoft Office, Google Suite, etc.) is required. Finally, the ideal candidate is curious, creative, engaged, and the type who works well independently and in teams while constantly looking for ways to advance scientific processes and improve technology.

What You’ll Do:

• 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.

Who You Are:

• 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 4+ years of experience.
• Expertise in purification technology and process development, transfer to cGMP manufacturing plants, and authoring CMC sections of regulatory filings.
• Experience withcommercial 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).

Why Join Us:

• Growth Opportunities : We’re a company that believes in continuous learning and development. Whether it’s professional courses, mentorship, or new projects, we’ll help you grow.
• Inclusive Culture : We’re committed to building a diverse and inclusive environment where everyone’s voice is valued, and curiosity is encouraged.
• Innovative Projects : You’ll have the chance to work on groundbreaking initiatives and cutting-edge technology in an atmosphere where your curiosity is the key to success.
• A Place for Big Ideas : We don’t just talk about thinking outside the box, we throw the box away. If you’ve got ideas, we want to hear them.

Are You Still Curious?

If you’ve read this far, then chances are you’ve got a curious mind—just like us. So, what are you waiting for? We can’t wait to see where your curiosity leads you—and how it will shape the future of Just-Evotec.

Let your curiosity guide your career #BeCurious and explore the endless possibilities at Evotec!

The base pay range for this position at commencement of employment is expected to be $126,000 to $137,000; Base salary offered may vary depending on individual’s skills, experience and competitive market value. Additional total rewards include discretionary annual bonus, comprehensive benefits to include Medical, Dental and Vision, short-term and long-term disability, company paid basic life insurance, 401k company match, flexible work, generous paid time off and paid holiday, wellness and transportation benefits.

Evotec (US) Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, gender, age, disability, genetic information, gender expression, gender identity, national origin, religion, sexual orientation, or veteran status.