Associate Director, Purification Process Development

The Role:

Were seeking an enthusiastic and hardworking leader who is passionate about expanding worldwide access to biotherapeutics through the advancement of continuous bioprocessing technology and mammalian cell culture processes.

This person will join a fast-paced collaborative and multidisciplinary team to support purification process development at bench and pilot scale for the advancement of low-cost biotherapeutics position will oversee purification process development and will include process optimization technology transfer and process characterization for hybrid and end-to-end continuous processes.

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 development for clinical and commercial therapeutic proteins. 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 Youll Do:

• Lead a diverse group of scientists and engineers responsible for all aspects of purification process development including process characterization and validation as well as technology transfer to cGMP manufacturing for hybrid and end-to-end continuous processes.

• Develop implement and continuously improve process development strategies aligned with company goals and client needs to accelerate development timelines and reduce costs while providing excellent client services

• Effectively model leadership behaviors in line with Evotec corporate culture and foster a culture of scientific excellence collaboration and continuous improvement.

• Lead highly complex projects and investigations by integrating deep knowledge of purification process development and broad knowledge of project work and functional areas covering biologics development and manufacture.

• Define and drive technology development strategies for process intensification and continuous manufacturing to reduce manufacturing costs and footprint through improvements in productivity product quality control and data management through collaboration with vendors internal and external partners as well as influencing the biologics industry.

• Serve 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.

• Serve as an internal technical resource for cGMP manufacturing MSAT 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 communicate scientific information experimental plans data and strategies 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; may also be invited to present and lead scientific meetings committees and workstreams

• Manage staff training capital resources and planning within the department to support multiple client and technology projects at various stages of process development and characterization.

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 leading a high functioning purification development team for process development projects and collaborations as well as technology development initiatives.

Pluses:

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

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

• Knowledge of cGMP and quality and/or regulatory requirements in the US and/or EU.

Why Join Us:

• Growth Opportunities: Were a company that believes in continuous learning and development. Whether its professional courses mentorship or new projects well help you grow.

• Inclusive Culture: Were committed to building a diverse and inclusive environment where everyones voice is valued and curiosity is encouraged.

• Innovative Projects: Youll 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 dont just talk about thinking outside the box we throw the box away. If youve got ideas we want to hear them.

Are You Still Curious

If youve read this far then chances are youve got a curious mind just like us. So what are you waiting for Take the leap and apply today. We cant wait to see where your curiosity leads you and how it will shape the future of Just-Evotec.

The base pay range for this position at commencement of employment is expected to be $154000 to $180000; Base salary offered may vary depending on individuals 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.