Associate Director, Purification Process Development

Evotec•Seattle, WA

4d•Onsite

About The Position

We're 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 manufacturing. This 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.

Requirements

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.

Nice To Haves

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.

Responsibilities

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.