Associate Director, Purification Process Development

Job Title: Associate Director, Purification Process Development

Location: Redmond

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:

We’re looking for a passionate and curious Associate Director, Purification Process Development to join our team. If you’re excited by new challenges, solving complex problems, and learning every step of the way, you might just be the perfect fit. In this role, you’ll have the opportunity to drive impactful projects, collaborate with bright minds, and explore uncharted territories.

As an Associate Director, Purification Process Development at Just-Evotec, you'll have the freedom to ask the hard questions, think outside the box, and find creative solutions that push us forward. It’s a role where your curiosity will fuel both your personal growth and the success of the team.

What You'll Do:

• Leading a purification department with 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 end-to-end continuous processes.

• Leading highly complex projects and investigations by integrating deep knowledge of purification process development and broad knowledge of project work with knowledge of multiple functional areas outside of purification.

• Collaborating across the organization to accelerate clinical development timelines while reducing development costs.

• 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 while working with vendors and external partners as well as influencing the biologics industry.

• Serving as a Project Team Lead within the process development organization to execute on client projects that involve multiple functional areas and the full range of regulatory stages.

• 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) and authoring CMC regulatory sections.

• Clearly and effectively communicating scientific information, experimental plans, and data to internal project teams, cross-functional area teams, senior management, external clients, vendors, and technology development collaborators as well as the external scientific community such as regulatory agencies, review boards, publications, and conferences.

• Managing staff, training, capital resources, and planning within the department while supporting multiple client projects at various stages of process development and characterization.

• Other tasks as assigned.

Who You Are:

• BS/MS in Engineering, Biochemistry, Biology, or related field with 15+ years of experience or Ph.D. in Engineering, Biochemistry, Biology, or related field with 9+ years of experience.

• Expertise in continuous purification technology 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 purification development teams for external client projects and collaborations and internal technology development initiatives. 

• Experience with high throughput methods (e.g. HT assays, robotics such as TECAN and Robo-Columns, and lab automation) is a plus.

Pluses:

• Experience analyzing data in tools such as JMP, R, or Python.

• 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).

• Experience working in retail, service industry, or other environments that require physical work and positive attitude.

Why Join Us: